title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Author contributions | Study concept and design: M.A.D.S., R.H.P., S.F.G., A.V.A.M., S.P.S., M.B.T., M.M.D.G., A.A.B. and E.B.S.G., M.A.M., E.B.S.G., B.A.B., J.B.C., C.W.L.M.O., T.L.R., P.C.G.L., M.S.A., F.M.L., C.K.V.N., B.S.F.S. and N.U.B. were involved in the acquisition of data. Drafting of the manuscript: M.A.D.S., R.H.P., F.T., J.C.R. ... | PMC10611696 | ||
Funding | The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and the decision to submit the manuscript for publication. | PMC10611696 | ||
Data availability | The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request. The authors confirm that the data supporting the findings of this study are available within the article and its supplementary material. | PMC10611696 | ||
Competing interests | The authors declare no competing interests. | PMC10611696 | ||
References | PMC10611696 | |||
Abstract | Editor: Linda WangConflict of interestThe authors declare no conflict of interest.The effectiveness of at-home dental bleaching treatments depends on the time that bleaching products are in contact with the teeth surface and, consequently, on the adequate use of associated custom acetate trays. | PMC10519669 | ||
Objective | TOOTH SENSITIVITY | This randomized single-blinded trial aimed to analyze if the daily usage time of these products influences the patient’s compliance behavior when submitted to monitored at-home dental bleaching. Secondary outcomes were color change and tooth sensitivity. | PMC10519669 | |
Methodology | TOOTH SENSITIVITY | Sixty-six volunteers were randomly distributed into three groups (n=22): patients were instructed to use the trays for 2 (G2), 4 (G4), and 8 (G8) hours daily. The daily dental bleaching compliance behavior was measured using a microsensor inserted into the trays. Subjective and objective color evaluation assessments w... | PMC10519669 | |
Results | G2 showed a greater degree of cooperation than G8 and cooperation was inversely proportional to the recommended usage time. Significantly higher color change was observed in the upper arch for G8 when compared to G2 in subjective analysis, from T1 to T4. There were no statistical differences between the groups in obje... | PMC10519669 | ||
Conclusion | Shorter recommended usage time of the bleaching product may improve the patient's compliance with at-home dental bleaching treatments. However, increased daily usage time may promote better subjective color change. Bleaching sensitivity was more significant in the first week for a longer time of use. | PMC10519669 | ||
Introduction | orthodontic | CAVITY, TOOTH SENSITIVITY | The effectiveness of at-home dental bleaching treatments depends on the time that bleaching products are in contact with the teeth surface and, consequently, on the adequate use of custom acetate trays. The home bleaching treatment was introduced in 1989, recommending the use of a 10% carbamide peroxide for 6 to 8 dail... | PMC10519669 |
Methodology | PMC10519669 | |||
Trial design | TOOTH SENSITIVITY | This study was a prospective, randomized, parallel, single-blind clinical trial, following the guidelines published by the Consolidated Standards of Reporting Trials-CONSORTThe studied factor was the usage time of the trays at three levels: 2 (G2), 4 (G4), and 8 (G8) hours/day. The response variables were the patient’s... | PMC10519669 | |
Sample size | SECONDARY | The sample size was calculated using a dedicated statistical software package (IBM SPSS Statistics 22.0; IBM Analytics, Armonk, NY, USA). The primary outcome (patient’s compliance behavior) was not used for sample size calculation due to the lack of data about this topic. One of the secondary outcomes was color change:... | PMC10519669 | |
Eligibility criteria | carious lesions, incisors, non-carious cervical lesions, pain, fluorosis, bruxism | ENDODONTICALLY TREATED TEETH, PERIODONTAL DISEASES, ADVERSE REACTION, TOOTH SENSITIVITY | Patients were selected according to the following inclusion criteria: absence of carious lesions; good oral soft tissue health; absence of unsatisfactory and/or fractured restorations; absence of periodontal diseases; absence of non-carious cervical lesions and exposed dentinal tissue in the incisal areas; no history o... | PMC10519669 |
Consort flow-chart of the clinical trial | PMC10519669 | |||
Allocation | After selecting the 66 participants, informed consent was obtained from each patient and they were divided into three groups with 22 participants each. Participants’ allocation into these groups was done at an equal rate. The purpose of this allocation was to assign each participant one out of three different usage tim... | PMC10519669 | ||
Bleaching procedure | Prophylaxis with pumice stone and water was performed. Alginate impressions (Jeltrate Plus, Dentsply, Petrópolis, RJ, Brazil) of each patient’s upper and lower arches were taken and stone models was fabricated. Ethylene vinyl acetate trays (Bio-Art Equip Odontológicos, Ltda, São Carlos, SP, Brazil) were fabricated usin... | PMC10519669 | ||
A- Upper and lower acetate trays with the microsensor attached to the buccal surface; B- Reading station for transferring data to the software | tooth | CAVITY | This microsensor is able to measure the temperature of the oral cavity every 15 minutes with a +/- 0.1º Celsius accuracy.Dental bleaching was performed using 10% carbamide peroxide gel (Opalescense PF, Ultradent Products Inc., South Jordan, UT, USA). Patients were instructed to insert a small drop of bleaching gel on t... | PMC10519669 |
Daily compliance behavior degree | A daily score for the usage time was created: 0 – patient did not used the trays; 1 – patient used the trays for the recommended time; 2 – patient used the trays for less than the recommended time; 3 – patient used the trays for more than the recommended time. The scores were then dichotomized into adequate (Score 1) o... | PMC10519669 | ||
Color change | ’ anterior teeth, incisors, tooth | Subjective and objective methods were used to evaluate tooth color. Only the evaluators were unaware of the groups to which the participants had been assigned. Two examiners were trained on shade determination of eight subjects’ anterior teeth in a pilot study. This calibration was performed using Vita shade guide unit... | PMC10519669 | |
Tooth sensitivity | TOOTH SENSITIVITY, TOOTH SENSITIVITY | Tooth sensitivity was analyzed and measured from 0 to 10 in all periods, according to the visual analogue scale (VAS). Volunteers were asked about the intensity of tooth sensitivity caused by the treatment. A value of 0 was set when patients did not have any sensitivity and 10 when severe sensitivity occurred. In case ... | PMC10519669 | |
Statistical analysis | ’ compliance behavior, tooth | Statistical analysis was performed using a statistical software package (IBM SPSS Statistics 22.0; IBM Analytics, Armonk, NY, USA). The Kolmogorov-Smirnov test was used to evaluate the normality of the results. The chi-square test was used between the groups to compare the volunteers’ compliance behavior (usage time). ... | PMC10519669 | |
Results | The 66 volunteers, aged 18 to 26 years (20±1.9 mean), were analyzed and a total of 462 readings (days of use) were performed for each study group, during the 21 days of treatment. No loss occurred during the follow-up periods. | PMC10519669 | ||
Daily compliance behavior degree | Data from daily compliance behavior is shown in
| PMC10519669 | ||
Distribution of patients’ 0-3 scores (usage time) according to each group | PMC10519669 | |||
Dichotomized data regarding the usage time of the dental bleaching product for upper and lower arches for each group (n=462). | PMC10519669 | |||
Color change | PMC10519669 | |||
Means (SD) of scores obtained by the subjective evaluation on upper and lower arches | Different uppercase letters in column and lowercase in row indicate statistically significant differences (p<0.05). Statistical analysis did not compare the upper arch with the lower arch.
| PMC10519669 | ||
Means (SD) of color change (ΔE00) obtained by the objective evaluation on upper and lower arches | Different uppercase letters in column and lowercase in row indicate statistically significant differences (p<0.05). Statistical analysis did not compare the upper arch with the lower arch.For all groups, arches, and analysis, a significant and gradual increase in color change was observed (p ≤0.05), stabilizing at T4. | PMC10519669 | ||
Tooth sensitivity | PMC10519669 | |||
Means (SD) of scores obtained by VAS scale during and after the bleaching treatment | Different uppercase letters in column and lowercase in row indicate statistically significant differences (p <0.05). | PMC10519669 | ||
Discussion | Usage-time compliance behavior | SECONDARY, TOOTH SENSITIVITY | This blinded, parallel, randomized clinical trial with similar allocation between treatment groups aimed to evaluate different aspects of bleaching treatment, such as daily compliance behavior, dental color change and tooth sensitivity. The main objective of this study was to assess compliance behavior daily—secondary ... | PMC10519669 |
Conclusions | TOOTH SENSITIVITY | Shorter recommended usage time of acetate trays/dental bleaching products improved patients’ compliance with the at-home dental bleaching treatment. However, increased daily usage time of the bleaching gel promoted better subjective color change. For a longer usage time, tooth sensitivity was more significant in the fi... | PMC10519669 | |
References | PMC10519669 | |||
Background | cancer, cancer pain, neuropathic pain, Pain | CANCER, CHRONIC PAIN, CORTEX | Pain is a common symptom in palliative care cancer patients and is often insufficiently relieved. In recent years, transcranial direct-current stimulation (tDCS) of the motor cortex has been shown to be effective to treat chronic pain, essentially neuropathic pain. We propose to test the efficacy of tDCS in patients ex... | PMC9972710 |
Method/design | Depression, Anxiety, Pain, pain | SECONDARY, REFRACTORY CANCER, CORTEX | This article describes the protocol of a bicentre, randomized, parallel-arm, sham-controlled clinical trial evaluating tDCS in the treatment of palliative care patients with refractory cancer pain. Seventy patients between the ages of 18 and 80 years experiencing refractory pain with a pain score of 4/10 on a numerical... | PMC9972710 |
Discussion | cancer, pain | CANCER, POSITIVE | Positive results of this trial would indicate that tDCS can improve pain and quality of life of cancer patients in the palliative care setting. Reduction of analgesic consumption and improvement of activities of daily living should allow many patients to return home with a decreased workload for caregivers. | PMC9972710 |
Keywords | PMC9972710 | |||
Background | cancer, cancer pain, chronic pain, Pain | CANCER, REFRACTORY CANCER, CHRONIC PAIN | Pain is a common symptom in palliative care cancer patients and is often insufficiently relieved [In recent years, noninvasive brain stimulation (NIBS) techniques (transcranial magnetic stimulation (rTMS) or transcranial direct-current stimulation (tDCS)) have been successfully used to treat chronic pain [tDCS appears ... | PMC9972710 |
Interventions: tDCS and follow-up intervention | paraesthesia, pain | CHRONIC PAIN, HEAT, CORTEX, PARAESTHESIA | tDCS was tested in healthy subjects from 2000 until 2005, at the time of the first clinical applications in the treatment of chronic pain. tDCS consists of delivering a low-intensity (1 to 2 mA) direct electrical current by means of a pair of electrodes (anode and cathode) applied to the scalp. Electrodes generally hav... | PMC9972710 |
Benefits and risks | pain | ADVERSE EFFECTS, SIDE EFFECTS, REFRACTORY CANCER, BLIND | At the individual level, pain intensity is expected to decrease by the 2nd or 3rd tDCS session, with a more marked improvement after the 5th session. This improvement is expected to last at least 4 days (D8) and up to 16 days (D21) [Side effects are recorded in the electronic observation booklet after each tDCS session... | PMC9972710 |
Study objective | Anxiety, Pain, cancer pain, pain, chronic pain, Depression, NRS | RESIDUAL, SECONDARY, CHRONIC PAIN, CORTEX | This study is designed to evaluate the analgesic efficacy of 5 consecutive tDCS sessions to the primary motor cortex in patients with cancer pain in the palliative care setting.The primary endpoint is the score of the numerical rating scale (NRS), which measures pain intensity on a scale from 0 to 10 [The secondary obj... | PMC9972710 |
General study methodology | drowsiness | This is a French bicentre (Clinique Bretéché and CHU/University Hospital Nantes), randomized, comparative, double-blind, sham-controlled trial conducted in two parallel arms: tDCS (35 patients) and sham tDCS (35 patients).Centralized randomization will be performed by software and will be specific to each of the 2 cent... | PMC9972710 | |
Inclusion criteria | cancer pain |
Patients between the ages of 18 to 80 years with cancer pain refractory to medical treatment (mean NRS ≥ 4/10 on 2 consecutive days) in the palliative care setting.Patients agreeing to participate in a research protocol in this palliative care setting. | PMC9972710 | |
Exclusion criteria | cognitive impairment, NRS, pain |
Patients younger than 18 years or older than 80 years.NRS < 4/10 (pain controlled by adapted medical treatment and global management).Patients unable to fill in the various questionnaires, specifically chosen to be simple and easy to fill in.Patients refusing to sign the informed consent form.Patients with cognitive i... | PMC9972710 | |
Recruitment modalities | RECRUITMENT | Patients will be recruited from the Center 1 (Clinique Bretéché rehabilitation and palliative care unit, Nantes), and Center 2 (CHU/University Hospital Nantes palliative care unit). The inclusion of one patient per month corresponds to the recruitment, treatment and follow-up capacities of each of these centres in acco... | PMC9972710 | |
Study plan (Fig. | PMC9972710 | |||
Screening visit (D-3) | D-3-D0, NRS, pain | Verification of inclusion and exclusion criteria. Patients will be provided with the information sheet and will be asked to sign the informed consent form. The patient will be provided with NRS forms (3 assessments per day for 48 hours). For organizational reasons, this screening visit will be held on a Friday. NRS sco... | PMC9972710 | |
Inclusion visit (visit 1) (D0) | NRS, pain | SECONDARY | Recording of NRS scores for 48 hours (D-3 to D-1) allowing inclusion of the patient. Recording of clinical parameters such as age, sex, weight, height, etc., medical history, previous and concomitant treatments, vital signs. Baseline assessment: NRS, BPI, ESAS, HADS, STAI-Y and MQS (see secondary endpoints). Randomizat... | PMC9972710 |
Treatment with active or sham tDCS (D0-D4) | NRS | Study personnel (physician or trained nurse), but not the patient, will be informed about the results of randomization. tDCS will be delivered daily for 5 consecutive days. The NRS will be scored 3 times a day on these 5 days from Monday to Friday. | PMC9972710 | |
Visit 2 (D8) | NRS | ADVERSE EVENTS | Review of adverse events (AEs), recording of NRS scores and the various other assessment scores (BPI, ESAS, HADS, STAI-Y and MQS) 4 days after stopping treatment. | PMC9972710 |
Patient follow-up | In order to maximize the number of patients evaluable for the primary analysis on the mITT population (modified intention-to-treat [ | PMC9972710 | ||
Clinical parameters | Anxiety, Pain, anxiety, cancer pain, pain, depressive, depression, Depression, NRS |
The pain numerical rating scale (NRS) is a pain self-assessment tool. The patient rates his or her pain orally on a scale from 0 to 10, where 0 corresponds to the lower limit defining absence of pain and 10 corresponds to the upper limit defining the worst imaginable pain. The NRS was preferred to a VAS (visual analog... | PMC9972710 | |
Statistical analysis | NRS | Statistical justification of the sample size: a 2-point improvement of the numerical rating scale is considered to be clinically relevant [As this is the first protocol dedicated to the treatment of painful patients in a palliative care setting with tDCS, we did not find any evidence in the literature that could help u... | PMC9972710 | |
Analysis of the primary endpoint | NRS, pain | Analysis of the primary endpoint, the pain NRS, will be performed on the mITT population.The mean NRS score on D8 will be compared between the active tDCS arm and the sham tDCS arm using a mixed linear model in order to take stratification factors into account. | PMC9972710 | |
Analysis of secondary endpoints | NRS, pain | The mean NRS score on D8 will be compared between the active tDCS arm and the sham tDCS arm using a mixed linear model in order to take stratification factors into account. This analysis will also be adjusted for analgesic consumption based on the MQS score.The immediate efficacy of tDCS on pain intensity will be compa... | PMC9972710 | |
Randomization | CRF, pain | CRF | Centralized randomization will be performed on D0 after verification of the inclusion criteria. Randomization will be performed under double-blind conditions and will be stratified according to the mean baseline pain intensity (4–6 or 7) over the last 48 hours before inclusion and according to centre.Patients will be r... | PMC9972710 |
Acknowledgements | The authors would like to thank Dr. A. Saul for English translation of the manuscript and Mr. A. Legrand (investigation project manager DRCI CHU Nantes), Mr. B. Orofiamma (Atlanstat) for their assistance in methodology and statistics and Dr. M. Royer for the coordination between the two centers (Groupe ELSAN, 58 bis ru... | PMC9972710 | ||
Dissemination of results | The results will be presented at feedback sessions at national and international congresses and may be used to compile guidelines on assessment of the efficacy and safety of tDCS. A research report based on the study results will be submitted to international peer-reviewed journals, in the field of palliative care, onc... | PMC9972710 | ||
Study status | The protocol is for a study that is ongoing, and the investigators are still collecting data. | PMC9972710 | ||
Authors’ contributions | CM, AVL, SVT | SVT | JPN, JN, HG, DCD and JPL wrote the manuscript. DCD, AE, AVL, HG are investigators of the Centre 1 (CHU/University Hospital Palliative care Unit), Nantes. AS, ETM, CM, and SVT are investigators of the Centre 2 (Clinique Bretéché, Nantes). All authors have read and approved the manuscript. | PMC9972710 |
Funding | STIMPAL Trial succeeded at 2019 Groupe ELSAN (Clinique Bretéché, 44000 Nantes, France) Call for research proposals, with a grant of 80.000 euros. This study protocol has undergone peer-review by the funding body. | PMC9972710 | ||
Availability of data and materials | All data will be anonymized and stored under lock and key, with access granted to the research team only in each of the 2 centers. | PMC9972710 | ||
Declarations | PMC9972710 | |||
Ethics approval and consent to participate | Domaine de la Santé́) | STIMPLAL design has been approved by Nantes Hospital Ethic’s Committee (GNEDS) Groupe Nantais d’Éthique dans le Domaine de la Santé́), on June, 12th 2019, and by the Comité de Protection des Personnes (CPP) Sud-Méditerranée II à Marseille on November, 6th 2020.All patients admitted to the units will be presented with a... | PMC9972710 | |
Consent for publication | Not applicable. This manuscript does not contain any individual person’s data. | PMC9972710 | ||
Competing interests | None. | PMC9972710 | ||
References | PMC9972710 | |||
Subject terms | adverse events, blood tests, SAD | ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT | OCS-05 (aka BN201) is a peptidomimetic that binds to serum glucocorticoid kinase-2 (SGK2), displaying neuroprotective activity. The objective of this randomized, double-blind 2-part study was to test safety and pharmacokinetics of OCS-05 administered by intravenous (i.v.) infusion in healthy volunteers. Subjects (n = 4... | PMC10060579 |
Introduction | neurodegeneration, acute optic neuritis, death, worsening disability, optic nerve demyelination, autoimmune encephalomyelitis, multiple sclerosis, ganglion cell loss), glaucoma, disability | NEURODEGENERATION, AMYOTROPHIC LATERAL SCLEROSIS, OPTIC NERVE, RETINA, NEURODEGENERATIVE DISEASES, AUTOIMMUNE ENCEPHALOMYELITIS, MULTIPLE SCLEROSIS, GLAUCOMA, DISEASES | Development of neuroprotective and remyelinating drugs is a high priority for central nervous system (CNS) diseases, including multiple sclerosis (MS)OCS-05 (previously known as BN201) is a neuroprotective and remyelinating drugCurrently OCS-05 has demonstrated neuroprotective properties by reducing the damage in the o... | PMC10060579 |
Results | PMC10060579 | |||
Safety | pneumonia, pain, SAD | PNEUMONIA, UPPER RESPIRATORY INFECTIONS, ADVERSE EVENTS, ADVERSE EVENT, EVENTS | A total of 56 subjects were enrolled in the study (Table Demographics of subjects.In the SAD part, there were a total of 10 TEAEs reported by 9 subjects (22.5%). The majority of subjects reported mild events, considered unrelated to OCS-05 (Table Overall summary of TEAEs – SAD part.During the MAD part, a total of 9 TEA... | PMC10060579 |
Pharmacokinetics | SAD | In SAD part, CSummary of derived pharmacokinetic parameters following single dose administration of OCS-05 (i.v. infusion) to healthy male and female subjects.Summary of derived pharmacokinetic parameters following single dose administration of OCS-05 (i.v. infusion) to healthy subjects as means (SD).C(ng/mL)54.3(20.7)... | PMC10060579 | |
Discussion | axonal degeneration, death, neuronal hypertrophy, SAD | OXIDATIVE STRESS, ASSOCIATED DISEASE | The safety profile of OCS-05 in healthy subjects was favorable at the tested doses in the SAD and MAD parts of this study. With the exception of TEAEs that tended to be higher following placebo during the MAD, there were no other treatment or dose-related trends in safety parameters observed during either part of the s... | PMC10060579 |
Methods | PMC10060579 | |||
Ethics statement | The study was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2000, and approved by the Wales Research Ethics Committee and the UK Medicines and Healthcare products Regulatory Agency. The study was registered in EudraCT (number 2017-001202-14) on 06/11/2020. Researchers have disclosed to pa... | PMC10060579 | ||
Study design | BLIND | This was a randomized, double blind, placebo controlled, 2-part single and multiple ascending dose study. The objectives were to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of OCS-05 in healthy subjects. Inclusion criteria included healthy (as judged by the Investigator; no clinically s... | PMC10060579 | |
Outcomes | ADVERSE EVENT, SECONDARY | The primary endpoint was the presence of Adverse Events (AEs), including and not limited to laboratory safety (biochemistry, hematology, and urinalysis); vital signs (supine systolic/diastolic blood pressure, pulse rate and body temperature); and 12-lead electrocardiogram (ECG: heart rate, PR interval, QRS duration, QT... | PMC10060579 | |
Treatments and doses | SAD | Subjects (n = 48) were randomly 1: 3 assigned to receive placebo (n = 12) or OCS-05 (n = 36). Due to the interlocking design where some subjects received more than one dose level, overall, 14 received placebo and 42 received OCS-05. In the single ascending dose part (SAD), doses administered with 2 h i.v. infusion were... | PMC10060579 | |
Statistical analysis | REGRESSION | Safety population was defined as every subject randomized and treated at least once with either placebo or drug. All statistical analysis were performed using SASAll OCS-05 concentrations and derived PK data were listed and individual and mean (arithmetic and geometric) concentration time data were plotted. Dose propor... | PMC10060579 | |
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-32278-0. | PMC10060579 | ||
Acknowledgements | We would like to thank Dr Joanne Chang from Oculis SA from her insightfully comments. Editorial assistance with the preparation of the manuscript was provided by Phil Hunt of Southdown Medical Writing Ltd, Worthing, UK, funded by Oculis SA. Anonymized data not published within this article will be made available by req... | PMC10060579 | ||
Author contributions | P.V.: study design, analysis, and wrote the article. M.M.: study design, analysis and reviewed the article. S.P.: study design, study management and reviewed the article. S.H.: study design, data acquisition, analysis and reviewed the article. A.K.: study design, data acquisition analysis and reviewed the article. | PMC10060579 | ||
Funding | This study was funded by Accure Therapeutics, Barcelona, Spain. OCS-05 has been licensed to Oculis SA, Lausanne, Switzerland which is conducting the phase 2 trial. | PMC10060579 | ||
Data availability | The study protocol and statistical analysis plan are available in the supplementary material. The datasets generated and/or analysed during the current study are not publicly available due agreement restrictions but are available from the corresponding author on reasonable request. | PMC10060579 | ||
Competing interests | MM | FOUNDER | PV holds a patent covering the composition of matter and uses of BN201. PV is a founder, holds stocks in Bionure SL, which has licensed the patent rights to Oculis SL and serves on its scientific advisory board, having been compensated by such activities. MM and SP were employees of Accure Therapeutics (formerly Bionur... | PMC10060579 |
References | PMC10060579 | |||
Background | prediabetes, TCM | DISEASE, PREDIABETES | Traditional Chinese medicine (TCM) theories assert that body constitution and meridian energy lay the foundation for disease prevention. TCM-based health concepts have not yet been incorporated into mobile health (mHealth) apps for individuals with prediabetes. | PMC10337399 |
Objective | prediabetes, TCM | PREDIABETES | The aim of this study was to examine the effectiveness of a TCM mHealth app for individuals with prediabetes. | PMC10337399 |
Methods | TCM, prediabetes | MAY, DISEASE, PREDIABETES, -20 | This randomized controlled trial recruited 121 individuals with prediabetes at a teaching hospital in New Taipei City between February 2020 and May 2021. The participants were randomly assigned to the TCM mHealth app group (n=42), ordinary mHealth app group (n=41), or control group (n=38). All participants received the... | PMC10337399 |
Results | TCM | Compared to the control group, the TCM mHealth app group showed greater improvement in hemoglobin A | PMC10337399 | |
Conclusions | prediabetes | PREDIABETES | Use of either the ordinary or TCM mHealth app improved HRQOL among individuals with prediabetes. Compared to the outcomes of controls not using any app, use of the TCM mHealth app was effective at improving HbA | PMC10337399 |
Trial Registration | ClinicalTrials.gov NCT04096989; https://clinicaltrials.gov/ct2/show/NCT04096989 | PMC10337399 | ||
Introduction | Prediabetes, prediabetes, Diabetes, T2DM, prediabetes or diabetes | PREDIABETES, PREDIABETES, DIABETES, DISEASE, TYPE 2 DIABETES MELLITUS | Prediabetes is a subhealth condition characterized by higher than normal blood sugar levels, but not yet at a sufficiently high level to warrant a diagnosis of type 2 diabetes mellitus (T2DM) [The Centers for Disease Control and Prevention Diabetes Prevention Program (DPP) has been shown to effectively delay or prevent... | PMC10337399 |
Methods | PMC10337399 | |||
Study Design | prediabetes | ADVERSE EVENTS, MAY, PREDIABETES | This study was an open-label, parallel-group RCT (ClinicalTrials.gov NCT04096989) with a three-group design. We cooperated with the health examination center and outpatient clinics at a teaching hospital in northern Taiwan to recruit individuals diagnosed with prediabetes from February 2020 to May 2021. The inclusion c... | PMC10337399 |
Ethics Approval | This study was approved by the institutional review board at Taipei Tzu Chi Hospital (approval no. 08-X-026). | PMC10337399 | ||
Intervention | belly breath, prediabetes, Hypertension, T2DM, TCM | DISEASE, HYPERTENSION, PREDIABETES | An expert team that included nursing researchers, TCM doctors, Western medicine doctors, and app developers was formed to guide the development of the intervention app. The team decided that the content embedded in the app would be developed in accordance with the DPP [The mHealth app (both the ordinary and TCM version... | PMC10337399 |
Data Collection | Dietary behavior, chronic disease | SECONDARY, CHRONIC DISEASE | Data were collected at baseline (T1), at the end of the 12-week intervention (T2), and 1 month after the intervention (T3). Sociodemographic characteristics (age, gender, marital status, education level, and employment status), clinical characteristics (history of chronic disease and use of TCM), and lifestyle factors ... | PMC10337399 |
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