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Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10154604 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC10154604 | ||
References | PMC10154604 | |||
Purpose | Communicated by Narihiko kondo.This study assessed whether increasing sodium in a sports drink above that typical (~ 20 mmol L | PMC9813217 | ||
Methods | Endurance trained males ( | PMC9813217 | ||
Results | Cycling time was similar 176 ± 9 min (Low Na | PMC9813217 | ||
Conclusions | HEAT | When conducting prolonged exercise in the heat, those who fully hydrate would benefit by increased sodium content of the beverage by improved plasma volume and sodium maintenance.Australian New Zealand Clinical Trials Registry (ACTRN12616000239460) 22/02/16. | PMC9813217 | |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00421-022-05025-y. | PMC9813217 | ||
Keywords | Open Access funding enabled and organized by CAUL and its Member Institutions | PMC9813217 | ||
Introduction | hyponatremia, EAH | HEAT, HYPONATREMIA | The role of sodium ingestion on the development of exercise associated hyponatremia (EAH) is uncertain (Hew-Butler et al. Therefore, the purpose of the present study was to evaluate plasma sodium and plasma volume responses to prolonged exercise in the heat with fluid losses compensated by a typical commercially available sports drink (21 mmol L | PMC9813217 |
Methods | BLIND | A double blind, randomized cross-over design was employed. Randomization was achieved via an on-line, random number generator. A technician allocated the treatment and assigned a letter to each. Researchers did not know which letter was which treatment. This study was approved by the University of Otago Human Health Ethics Committee (H16/002). | PMC9813217 | |
Pre-trials | FLUID LOSS | Participants gave written informed consent and filled in an activity and health questionnaire (PAR-Q). Body mass and height were measured and, thereafter, a graded maximal oxygen consumption (Those meeting the pre-determined inclusion criteria (see below) attended another session in which fluid loss was estimated during 1 h of cycling to determine fluid intake for experimental trials. This was conducted under the same conditions as experimental trials, cycling at 55% | PMC9813217 | |
Participants | cardiovascular or kidney disease | Inclusion criteria comprised regularly exercising, male, no cardiovascular or kidney disease, no medications or supplements excepting vitamins or sports drinks, passed PAR-Q, and a Eighteen participants responded to advertisement, 18 came to the lab for an initial visit, 16 passed the screening and Based upon earlier work (Vrijens and Rehrer | PMC9813217 | |
Experimental trials | RPE, thirst, fluid loss | FLUID LOSS | Each participant consumed a diet of his choice before the first trial but was required to eat this same diet before the second trial. The last meal was consumed 2 h before each trial. Participants were also instructed to drink 1 L of a commercial sports drink (6 g LThe trials were planned to consist of cycling for three hours at 55% Participants arrived approximately ~ 1 h before exercise was to start. They first voided their bladders and collected a urine sample, for urine specific gravity (USG) measurement to assess hydration status, and then were weighed. Thereafter, a rectal thermistor was inserted (11 cm past the anal sphincter), cycling clothes were put on and a heart rate monitor was attached. A venous catheter was placed in an antecubital vein and, after sitting for 10 min, the first baseline blood sample and other baseline physiological and subjective measures were taken. Participants then moved into the climate-controlled chamber and began cycling.The beverage was consumed every 15 min (from 15–165 min) at a rate equal to the fluid loss, determined in the pre-trial.Core temperature and heart rate (Polar Electro, Finland) were monitored continuously and recorded at 15 min intervals along with ratings of perceived exertion (RPE) (Borg scale 6–20) (3), body temperature sensation (scale 1–13) and thirst (scale 1–9). Subjective ratings were collected prior to beverage consumption and any blood draw.Nude body mass (after voiding and drying) was also recorded before and after any trips to the toilet and at the end of each trial. Urine was collected, volume and USG of the post-exercise micturition were measured. Some urine samples were not collected. Criteria for terminating a trial before the planned three hours were: (1) a plasma sodium ≤ 130 mmol L | PMC9813217 |
Blood sampling and analyses | sweat loss, mass loss, Sweat loss | BLOOD | During each trial, venous blood samples were obtained from an indwelling catheter (22G, Becton Dickenson, Madrid, Spain) in an antecubital vein. Blood was drawn every 30 min during, and upon completion of, exercise. In total, during each experiment, ~ 30 ml of blood was drawn. Blood samples were analyzed immediately for sodium (GEM Premier 3000, Instrumentation Laboratory, Bedford, USA) and hematocrit and hemoglobin (OSM 3, Radiometer Medical, Brønshøj, DK). Changes in plasma volume (PV) were calculated according to Dill and Costill (Dill and Costill Sweat loss was estimated by change in body mass corrected for mass loss from toileting and fluid intake. Rates of sweat loss were calculated by dividing by exercise time. | PMC9813217 |
Data analyses | Data are expressed as mean ± standard deviation. A Dataset analyzed in the current study is available from the corresponding author upon reasonable request. | PMC9813217 | ||
Results | PMC9813217 | |||
Participants, trial completion and compliance | mass loss | Three participants dropped out after the 1 h pre-trial because of time commitments. Another participant dropped out, because he fainted in the first trial after half an hour. He came back to repeat the trial, but felt unwell again and exited the study. Twelve participants conducted exercise trials in both conditions. One participant did not adhere to the treatment protocol having drunk significantly less than prescribed (% body mass loss > 2 × SD) and his data were, therefore, removed from all analyses. The 11 males who were included in results had a mean age of 36 ± 14 y, mass of 75.36 ± 5.30 kg, height of 180 ± 6 cm and | PMC9813217 | |
Plasma sodium | Plasma sodium concentration over the course of exercise trials was greater with High NaPlasma sodium concentration in males during cycling (55% | PMC9813217 | ||
Plasma volume change | Plasma volume decreased over the course of exercise with Low NaChange in plasma volume in males during cycling (55% | PMC9813217 | ||
Heart rate, thermal and subjective responses | warmth, thirst, Thirst | HEART | Heart rate increased over time in both trials (Fig. Heart rate in males during cycling (55% Mean rectal temperature increased over time (Core temperature (°C) in males during cycling (55% Thirst was not different between conditions (Subjective measures of thirst, warmth and perceived exertion in males during cycling (55% Participants felt hotter in Low Na | PMC9813217 |
Discussion | thirst, stroke, hyponatremia, hypohydration, sweat loss, mass loss | STROKE, HYPONATREMIA, EVENT, FLUID LOSS, HEAT | The current finding of maintaining plasma sodium concentration and plasma volume when fluid loss was replaced with a beverage having a sodium concentration of 60 mmol LSodium has direct and indirect effects to regulate plasma volume which can affect exercise performance and strain, particularly due to effects on stroke volume and cardiac output (Luetkemeier and Thomas In line with our plasma volume results, body mass loss also tended to be less with High NaWith shorter exercise endeavors than in the present study, lower intensity and/ or cooler temperatures, sweat rate, sweat sodium concentration and total sweat loss would be less (Baker The lack of difference in heart rate and core temperature between conditions in the present study correlates with the similar RPE observed, however, unexpectedly, perceived warmth was greater with Low NaAdvocating “drinking to thirst”, while thirst is not always associated with a given level of hydration (Armstrong et al. Although not replacing sweat losses and allowing hypohydration to ensue is one way to ensure that plasma sodium concentration is not reduced, this may be at the expense of total body and extracellular water, and plasma volume. For the recreational athlete this may be acceptable, when maintaining a given intensity or performance is not critical. This may even be preferable to risking hyponatremia in the large group of non-competitive endurance event participants that are most at risk. For competitive endurance athletes, particularly in the heat, sweat rates can exceed 2 L h | PMC9813217 |
Limitations | HEAT | Our findings are based on a situation in which large fluid losses are replaced with large fluid intakes and would not necessarily be applicable to those who do not lose and replace a considerable amount of body fluid during exercise, or in those who ingest considerable amounts of sodium in other foods or supplements in conjunction with fluid replacement. We also do not know if similar responses would be found in those heat acclimatized. | PMC9813217 | |
Conclusions | EVENTS | In endurance events lasting ~ 3 h (or more), athletes who experience significant sweat losses, and compensate them with fluid intake, may benefit from increasing the sodium concentration of beverages consumed. Beverages with increased sodium (60 mmol h | PMC9813217 | |
Supplementary Information | Below is the link to the electronic supplementary material.Supplementary file1 (DOCX 13 KB)Supplementary file2 (TIFF 80 KB)Supplementary file3 (TIFF 28 KB) | PMC9813217 | ||
Acknowledgements | Barrett | BARRETT | The authors would like to thank the participants, Margie Bryant, Rochelle Palmay, Nigel Barrett and Meredith Peddie for technical assistance and Arthur Siegel for his suggestion to undertake this research. | PMC9813217 |
Funding | Open Access funding enabled and organized by CAUL and its Member Institutions. The research was supporting by internal funding from The School of Physical Education Sport and Exercise Sciences, Otago University. Sports drink was donated by Frucor New Zealand. | PMC9813217 | ||
Declarations | PMC9813217 | |||
Conflict of interest | The authors declare that they have no conflict of interest. | PMC9813217 | ||
References | PMC9813217 | |||
Objectives | To compare the cleansing efficacy of an auto-cleaning device with nylon bristles ( | PMC9889468 | ||
Materials and methods | PLAQUE | Twenty probands refrained from oral hygiene for 3 days. Rustogi Modified Navy Plaque Index was assessed before and after (randomized) toothbrushing either with the auto-cleaning device for 5 s per jaw or with a manual toothbrush for a freely chosen time up to 4 min. The clinical investigation was repeated in a cross-over design. In a third trial period, the brushing time for auto-cleaning was increased to 15 s per jaw. The study was supplemented by plaster cast analyses. | PMC9889468 | |
Results | PLAQUE | Full-mouth plaque reduction was higher with manual toothbrushing than with auto-cleaning for 5 s per jaw ( | PMC9889468 | |
Conclusions | PLAQUE | Auto-cleaning devices with nylon bristles have a future potential to reach plaque reduction levels comparable to manual toothbrushing, although manufacturers must focus on improving an accurate fit. | PMC9889468 | |
Clinical relevance | Under the premise of an ameliorated fit, the auto-cleaning device might be recommendable for people with low brushing efficacy. Interdental sites remain a failure point if adjunct interdental cleaning is not viable. | PMC9889468 | ||
Keywords | Open access funding provided by University of Innsbruck and Medical University of Innsbruck. | PMC9889468 | ||
Introduction | periodontitis, tooth | PERIODONTITIS, DISEASES, DENTAL CARIES, PLAQUE | Dental caries and periodontitis are biofilm-based behavior-mediated diseases, which could be largely prevented by relatively inexpensive measures such as home-based mechanical plaque removal, fluoride application, repeated individualized oral hygiene instructions with professional tooth cleaning, and risk factor control [The auto-cleaning device The purpose of this randomized-controlled and single-blinded cross-over study was to compare the cleansing efficacy of an auto-cleaning device with nylon bristles and flexible mouthpiece with that of uninstructed manual toothbrushing. The null hypothesis was that there would be no difference in plaque reduction between the two brushing methods in randomly selected probands. | PMC9889468 |
Material and methods | The Ethics committee of the Medical University of Innsbruck, Austria, approved the study (ID AN 5123). The study was conducted in accordance with the 1964 Helsinki declaration and its later amendments. All subjects signed an informed written consent prior to the study enrollment. | PMC9889468 | ||
Study subjects | Twenty volunteers were recruited from the Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck (Austria). Inclusion criteria were (1) age ≥ 18 years, (2) contractual capability, and (3) the presence of ≥ 5 teeth per quadrant. Exclusion criteria were (1) dental students or professionals, (2) oral hygiene instructions prior to the study, (3) community periodontal index of treatment needs (CPITN) grade 3 or 4 [ | PMC9889468 | ||
Clinical intervention | PLAQUE | The cleansing efficacy of brushing with the auto-cleaning device Due to unsatisfactory plaque removal with the used | PMC9889468 | |
Rustogi Modified Navy Plaque Index [ | carious teeth | CARIOUS TEETH, PLAQUE | The index divides buccal and lingual surfaces into nine areas (A to I) that are scored for the presence (score = 1) or absence (score = 0) of plaque. It is based on a dichotomous principle and assesses the presence of plaque on a whole mouth basis (areas A–I), interdental basis (areas D and F), and the gingival margin basis (areas A–C) and thus allows to evaluate each area separately. Third molars and carious teeth were excluded from the evaluation, whereas teeth with fillings, inlays, onlays, or crowns were included. RMPNI is calculated as percentage of biofilm adhering sites to measured sites. | PMC9889468 |
Statistical analysis | pre-minus, tooth | PLAQUE | On a proband level, RMNPI values were calculated as the total number of tooth areas with plaque present divided by the total number of tooth areas scored, and median and range are given. The amounts of plaque reduction (pre-minus post-plaque scores) were calculated and mean reduction in the whole mouth, as well as interdental and marginal plaque scores, was compared between the two tooth brushing procedures by Wilcoxon’s signed-rank test. If not stated otherwise, median and range are given. The significance level was set at | PMC9889468 |
Results | Twenty individuals (10 females and 10 males; all Caucasians) with a median age of 29.3 years (range 20.3–63.1 years) participated in this study. For manual toothbrushing, the median brushing time was 181 s (range 110–240 s). | PMC9889468 | ||
Plaque reduction with | PLAQUE | For evaluating the effect of longer brushing with the auto-cleaning device, we increased the brushing time per jaw from 5 to 15 s. Ten probands were willing to participate in this second part of the study (non-blinded, non-randomized). After 3 days of plaque accumulation, there was no statistically significant difference for pre-brushing RMNPI compared to the first part of the trial (median 59.65%; range 18.52–71.23%; | PMC9889468 | |
Plaster cast analysis | plaster | PLAQUE | Brushing efficacy of the auto-cleaning device was further analyzed regarding the widths and lengths of the jaw arches. No statistically significant correlations were found between the widths of the jaws and post-brushing plaque indices. There were statistically significant correlations between the post-brushing plaque indices and the length of the upper and lower jaw with Assessment of accurate fit on plaster casts. Then, we looked in detail on the marginal areas as on these sites the plaque reduction was unsatisfactory even after brushing with the 15-s mode of the auto-cleaning device. In 382 teeth (30.67%), the gingival margin was not covered by the bristles when pushing the mouthpiece gently on the plaster cast. For these teeth, the distance between the bristles and the gingival margin was 3.13 ± 2.30 mm (range 0.5–9 mm). Number of plaque-positive marginal areas (measured during the clinical trial) was statistically significantly higher in teeth marginally not covered by the mouthpiece than in marginal areas covered by the bristles in plaster cast analyses (1.81 ± 1.16 and 1.59 ± 1.23, respectively; | PMC9889468 |
Discussion | Tooth | PLAQUE, PLAQUE | Tooth brushing efficacy is largely dependent on patients’ motivation, manual dexterity, and knowledge of how to brush. It was recently shown that the efficacy of toothbrushing is not a matter of brushing time but of establishing brushing systematics leading to evenness of distribution of brushing time [In a recent study investigating an auto-cleaning device with silicon nubs (In the present study, we decided to assess the Rustogi Modified Navy Plaque Index [In the authors’ opinion, the development of auto-cleaning devices seems a gratifying approach to increase both the frequency and the efficacy of toothbrushing which have been ascertained to be insufficient in the majority of adults, adolescents, and children [Additional plaster cast analyses revealed that for all but one individual, the mouthpiece was too short consequently not completely covering second molars with a range of 0.5 to 11 mm. The manufacturer recommends moving the mouthpiece gently from one side to the other during the brushing process probably to overcome a non-accurate fit. This movement might compensate some millimeters. In the present study, the distance of the occlusal surface not covered by the mouthpiece in rest was statistically significantly correlated with plaque retention on appropriate teeth (The limitation of the present study is that the elongated brushing mode of the | PMC9889468 |
Funding | Open access funding provided by University of Innsbruck and Medical University of Innsbruck. | PMC9889468 | ||
Declarations | PMC9889468 | |||
Ethics approval | Ethics committee of the Medical University of Innsbruck, Austria, approved the study (ID AN 5123). | PMC9889468 | ||
Conflict of interest | The authors declare no competing interests. | PMC9889468 | ||
Informed consent | Informed consent was obtained from all individual participants included in the study. Patients signed informed consent regarding publishing their data and photographs. | PMC9889468 | ||
References | PMC9889468 | |||
Background | stroke, disability, Stroke, decrease disability | STROKE, STROKE | Stroke is a leading cause of disability among adults worldwide. A timely structured follow-up tool to identify patients’ rehabilitation needs and develop patient-tailored rehabilitation regimens to decrease disability is largely lacking in current stroke care. The overall purpose of this study is to evaluate the effectiveness of a novel digital follow-up tool, Rehabkompassen®, among persons discharged from acute care settings after a stroke. | PMC10559468 |
Methods | stroke | STROKE | This multicentre, parallel, open-label, two-arm pragmatic randomized controlled trial with an allocation ratio of 1:1 will be conducted in Sweden. A total of 1106 adult stroke patients will have follow-up visits in usual care settings at 3 and 12 months after stroke onset. At the 3-month follow-up, participants will have a usual outpatient visit without (control group, | PMC10559468 |
Discussion | stroke | STROKE | The outcomes of this trial will inform clinical practice and health care policy on the role of the Rehabkompassen® digital follow-up tool in the post-acute continuum of care after stroke. | PMC10559468 |
Trial registration | ClinicalTrials.gov NCT04915027. Registered on 4 June 2021. ISRCTN registry ISRCTN63166587. Registered on 21 August 2023. | PMC10559468 | ||
Keywords | Open access funding provided by Umea University. | PMC10559468 | ||
Introduction | PMC10559468 | |||
Background and rationale {6a} | ®, stroke, heterogeneous disabilities | STROKE | In Sweden, there are 100,000 stroke survivors and 23,000 new cases each year [To understand patients and their heterogeneous disabilities, patient-reported outcome measures (PROMs) are widely used to promote patient-centred and patient-tailored care [To meet these challenges, we created and developed a digital graphic follow-up tool, RehabkompassenRehabkompassen® identified more (The novelty of this instrument lies in its ability to provide an easy-to-understand and comprehensive picture of a stroke patient’s multidimensional problems/rehabilitation needs in a time-efficient way. Patients respond to RehabkompassenTo use Rehabkompassen® in the health care system, a person with stroke completes the digital questionnaires, often at home, prior to a patient visit. The medical professionals can then assess the patient’s Rehab-Compass Graph before, during and after the visit. The figure published in our previous study [By developing the novel Rehabkompassen | PMC10559468 |
Objectives {7} | PMC10559468 | |||
Primary research question | stroke, PSC, ® | STROKE | Does the incorporation of the digital Rehabkompassen® tool in usual care within 3 months after stroke onset result in improved daily and social activities for patients at the 12-month follow-up after stroke onset compared to those receiving usual care with the Post-Stroke Checklist (PSC)? | PMC10559468 |
Secondary research questions | poststroke, fatigue, anxiety, stroke, depression | STROKE, SECONDARY | The aim is to investigate the following by comparing usual care with the PSC ® (control group) to usual care with the usage of the digital RehabkompassenThe improvement of technical and methodological aspects of Rehabkompassen® based on feedback from end-users, including both patients and health care practitionersThe provision of information that affects and/or facilitates the implementation of the Rehabkompassen® toolThe facilitation of triage, clinical assessments, decision-making, the development of a rehabilitation plan, referrals and outcome evaluations for health care professionalsThe influence on secondary outcome measures, including fatigue, depression, anxiety and other stroke impacts, at the 12-month poststroke follow-upThe impact on patients’ health-related quality of life at the 12-month follow-up after stroke onsetThe demonstration of the cost-effectiveness of the tool | PMC10559468 |
Trial design {8} | The Rehabkompassen study is a Swedish, parallel, open-label, two-arm prospective multicentre pragmatic RCT with an allocation ratio of 1:1 to investigate whether the usage of the novel digital RehabkompassenCONSORT flow chartThis trial protocol is reported in line with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist [ | PMC10559468 | ||
Methods: participants, interventions and outcomes | PMC10559468 | |||
Study setting {9} | stroke | STROKE | Participants will be recruited from approximately 15 centres across Sweden, including stroke units, early support discharge units and stroke rehabilitation units that provide care for persons within 3 months after stroke onset. Together with usual care, the control or intervention regimens will be flexibly delivered in in- or outpatient settings via either face-to-face or synchronous video visits in university, regional or local hospitals. | PMC10559468 |
Eligibility criteria {10} | PMC10559468 | |||
Patient-participant eligibility | stroke | STROKE | We aim to enrol as many stroke survivors as possible in usual care with little selection using the following criteria:Inclusion criteriaAdults aged 18 years or older.Time since stroke onset: individuals must be within the first 4 months after stroke, starting from day 1 after the occurrence of the stroke.Patients discharged from acute care settingsExclusion criteriaUnable to answer the evaluation questionsUnable to see the RehabkompassenNot using BankID, an e-identification tool commonly used in Sweden | PMC10559468 |
Clinical eligibility | poststroke, stroke | STROKE | Inpatient and outpatient clinics must meet the following eligibility criteria to participate in the study:Have assignments for stroke patient follow-up and rehabilitation.Able to provide in- and outpatient visits within 3 months and at 12 months poststroke.Have a team with at least one physician and one nurse/other health care professional.Have a referral system including both primary care and municipal care.The reason for these requirements for participating clinics is to not only guarantee patient and staff resources but also to be able to study the cooperation among different care providers in the post-acute continuum of care after stroke. | PMC10559468 |
Staff eligibility | Together with the Chief Investigator and the trial management group (TMG; see details in the “ | PMC10559468 | ||
Who will obtain informed consent? {26a} | stroke | STROKE | All patients with stroke in the participating clinics during the study period will receive an invitation to participate in the study from the research personnel within 3 months after stroke onset. Written informed consent will be obtained by the research personnel prior to the participant undergoing study procedures. Research staff at the local clinic will contact patients who give their consent via telephone to provide oral information about the study, answer questions and determine whether the patients meet the selection criteria. The research staff will ensure that patients have sufficient time to consider their participation. All patients who meet the selection criteria and provide written consent will thereafter be randomized into the control or intervention group.Study personnel will also provide their written informed consent prior to answering the questionnaires. Thus, written, informed consent to participate will be obtained from all participants. | PMC10559468 |
Additional consent provisions for the collection and use of participant data and biological specimens {26b} | No biological specimens will be collected in the study. | PMC10559468 | ||
Interventions | PMC10559468 | |||
Explanation for the choice of comparators {6b} | stroke, PSC | STROKE | A parallel, active control including the PSC with usual in- or outpatient visits is planned in the control group in the study. The PSC is a simple valid instrument for providing a structured follow-up for persons after stroke [ | PMC10559468 |
Intervention description {11a} | ® | The intervention will consist of the usage of RehabkompassenParticipants in the intervention group will receive the RehabkompassenSimilar to the pilot study [All participants will use Rehabkompassen as a structured follow-up tool at the 12-month visit. In the intervention group, the patients’ personal Rehabkompassen® graphs at the 3- and 12-month visits allow assessment for evaluating the eventual effects of rehabilitation regimens or illustrating the changes in rehabilitation needs over time (Fig. | PMC10559468 | |
Postvisit assessments | After the 3- and 12-month follow-up visits, all patient-participants in both the intervention and control groups will answer a satisfaction questionnaire through 1177.se. The questionnaire will concern their overall experiences during the follow-up visit. Based on their needs, patients will receive various rehabilitation regimens according to the clinical routine after the visit, which will also be recorded by the health care practitioners via Research Electronic Data Capture (REDCap) [The health care personnel involved in the study will answer a questionnaire concerning their satisfaction and the specific perceived usability of the instrument in clinical practice via REDCap three times during the study period, i.e. at the beginning, middle and end of the study. | PMC10559468 | ||
Criteria for discontinuing or modifying allocated interventions {11b} | There are no provisions for changing the trial arm allocation. However, participants may withdraw from the study without the need to provide a reason and their future care will not be affected. Any data collected up to the point of withdrawal will be included in the analyses. | PMC10559468 | ||
Strategies to improve adherence to interventions {11c} | stroke | STROKE | To optimize adherence to the study, we will provide various necessary help during the study. We are aware of some potential barriers for stroke patients, especially elderly individuals, to use the digital tool and answer many questions. Therefore, research staff will be available to offer technical support via telephone or in person when needed in addition to providing initial detailed instructions on how to answer the questionnaires. Since we consider that these questionnaires might be excessively burdensome for participants, the research staff member/nurse will encourage participants to take a break if they feel tired while completing them or to complete the ePROMs on different days. More advanced technical support during the study will be provided by technical staff on the research team. In addition, the 12-month visit is free of charge, which may improve adherence to the intervention.The Chief Investigator and two research nurses will always be reachable during working hours for trouble-shooting and problem-solving during the study. Two RCT process controllers will regularly check all documentation of the participating clinics to ensure consistency among clinics. Annual trial meetings will be organized for all unit-allied health professionals for exchanging experiences and spreading knowledge. Monthly newsletters and ongoing e-mails will also be used for updates regarding the study progress and to facilitate communication during the study. | PMC10559468 |
Strategies to improve the fidelity of the study | Rehabkompassen® | RECRUITMENT | To minimize the differences among clinics, all unit-allied health professionals in the participating clinics will complete a training program on the usage of Rehabkompassen® in a setup phase before participant recruitment. To successfully implement the tool in broad routine clinical practice in the pragmatic RCT, a baseline survey concerning usual follow-up at each clinic will be completed before the start of the study, and any adjustment according to a usual care standard will be documented. Unit staff, including the multidisciplinary team, will participate in an orientation and information session about the study prior to the start of the study. Episodes of staff education and training will be provided for new staff on the unit. To implement and deliver the control and intervention regimens continuously, the participating clinics will receive annual economic compensation based on the number of participants who complete the study protocol. | PMC10559468 |
Relevant concomitant care permitted or prohibited during the trial {11d} | No restrictions will be imposed on usual care during the study period. All rehabilitation treatments, including concomitant care and the intervention, will be documented at the 12-month follow-up. | PMC10559468 | ||
Provisions for posttrial care {30} | No formal postcare provision is planned in the study. However, the rehabilitation needs identified at the 12-month follow-up will be treated according to the clinical routine in the respective participating clinics. | PMC10559468 | ||
Outcomes {12} | stroke, Stroke | STROKE, STROKE | Participants’ demographic data (e.g. age, sex, comorbidities, stroke characteristics and severity) will be obtained via REDCap or from the Swedish Stroke Register (Riksstroke) at the first visit (T1 in Table Schedule of enrolment, interventions, and assessmentsx: for the patients in the intervention group; #: for the patients in the control group | PMC10559468 |
Participant timeline {13} | RECRUITMENT | The patient-participant timeline was created according to SPIRIT guidelines [We enrolled our first participant on 7 February 2022. We expect to enrol the final participant at the end of 2024. The total recruitment period will be 3 years. Approximately 40% and 45% of the sample will be recruited in 2023 and 2024, respectively. The 12-month follow-up will be completed at the end of 2025, followed by data analysis, manuscript preparation and submission in 2026 (Table A GANTT schedule of the study | PMC10559468 | |
Sample size {14} | stroke, Stroke | STROKE, STROKE | The study is predicted to have 90% power in the analysis of both primary outcomes at a significance level of 2.5% for each individual test to account for planned correction for multiple comparisons with a target familywise error rate of 5%.Sample size calculations were performed assuming a mean difference of 4 points in the SIS-p score between the groups at the 12-month follow-up. There is uncertainty regarding the minimum clinically important difference in the SIS-p, but differences in sizes between 10 and 15 points have previously been suggested [The sample size calculation for the mRS score was based on aggregated unpublished data from the Swedish Stroke Register (Riksstroke). The marginal distribution of mRS scores collected 12 months after stroke among Swedish patients was Thus, 940 patients should be sufficient for both primary outcomes. To account for a 15% loss to follow-up rate, we plan to recruit 1106 patients for the study (Fig. | PMC10559468 |
Recruitment {15} | stroke | EVENTS, RECRUITMENT, STROKE | To achieve the target sample size, patients will be recruited from approximately 15 participating outpatient clinics throughout Sweden. The participating clinics have been and will be recruited either by personal contacts or after the study is promoted at the national and regional conferences.To attract more clinics to participate in the study, the Chief Investigator will continuously promote the study at professional and lay-community conference/educational events. To attract more patients, recruitment posters with the contact details of research staff will be displayed at each participating site. All stroke survivors in the participating clinics will receive the study information and a letter inviting them to participate in the study. Other study awareness efforts, including clinical trial finder websites and word of mouth, will also be used to enhance the recruitment of clinics and participants. Moreover, recruitment status relative to planned targets will be reviewed monthly by the administrative study team, and the Chief Investigator will adjust the recruitment plans as needed. | PMC10559468 |
Assignment of interventions: allocation | PMC10559468 | |||
Sequence generation {16a} | The allocation sequence will be created centrally using computed-generated random numbers stratified by clinic. To reduce predictability, permuted block randomization will be used with random block sizes from 2 to 8 to ensure that participants are randomly assigned to the intervention or control group [ | PMC10559468 | ||
Concealment mechanism {16b} | RECRUITMENT | A statistician (the second author) who is not involved in outcome assessment or the patients’ treatment will generate the allocation sequence. The allocation sequence will be installed in REDCap, which will be concealed from the study personnel working in participant recruitment. The study personnel in each clinic will automatically receive an allocation decision with a study number when they register a new patient in REDCap. | PMC10559468 | |
Implementation {16c} | Research staff at the local clinic will enrol participants via REDCap, which will automatically assign participants to either the control or intervention group. | PMC10559468 | ||
Assignment of interventions: blinding | PMC10559468 | |||
Who will be blinded {17a} | As in many rehabilitation intervention studies, this is an open-label study in which a double-blind intervention is not possible. Group allocation will be blinded in data analysis by two statisticians. | PMC10559468 | ||
Procedure for unblinding if needed {17b} | The design is open label with only data analysts being blinded so unblinding will not occur. | PMC10559468 | ||
Data collection and management | PMC10559468 | |||
Plans for assessment and collection of outcomes {18a} | We will use 6 validated and reliable PROMs as the outcome measurements in the study (see Table | PMC10559468 | ||
Plans to promote participant retention and complete follow-up {18b} | stroke | STROKE | We will employ several strategies to promote complete participant follow-up. A free clinical visit at approximately 12 months after stroke onset is an important promotor to enhance participant retention. Before the 3- and 12-month visits, an appointment date will be sent to the participants via regular mail, which will be followed by a phone call from research personnel. Moreover, all participants will receive the Rehabkompassen | PMC10559468 |
Data management {19} | PROM | Rehabkompassen will collect PROM data automatically, which will be kept securely in electronic form in the Region of Västerbotten with regular backups. Baseline data collection will be carried out by using REDCap, hosted at Umeå University. REDCap [ | PMC10559468 | |
Confidentiality {27} | All study personnel will endeavour to protect the rights of the participants to privacy and informed consent. All information collected will be treated confidentially in accordance with the consent provided, adhering to the EU data protection rules ( | PMC10559468 | ||
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | This is not applicable as no biological specimens will be collected. | PMC10559468 | ||
Statistical methods | PMC10559468 | |||
Statistical methods for primary and secondary outcomes {20a} | REGRESSION | Group differences in the mRS and SIS-p scores at the 12-month follow-up will be tested using ordinal logistic (proportional odds) regression, adjusted for site with fixed effects [For the two primary outcomes, adjustments of the significance levels of the individual tests will be performed using the Holm–Bonferroni method to ensure that the familywise error rate will not be inflated above 0.05.Secondary outcomes on an ordinal scale will be analysed similarly using ordinal logistic regression. All analyses will primarily be conducted in accordance with the intention-to-treat principle. As complementary analyses, per-protocol analyses will be performed using data from patients with full availability of primary variables and predefined criteria for adherence. Further details about the statistical analyses will be predefined and published in a separate statistical analysis plan. A data management plan has been established, providing details of the handling, organization and storage of study data.A statistical significance level of | PMC10559468 | |
Interim analyses {21b} | No interim analyses are planned. | PMC10559468 |
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