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Study flow | Five pharmacies participated in this study. However, one of them withdrew before the start of the study because the prescribing practitioners did not consent to provide assistance to this study. The remaining four pharmacies were allocated to the intervention and control groups at a 1-to-1 ratio. During the study, 6 pa... | PMC9951417 | ||
Patient attributes | Table
Patient attributesIG: Intervention group, CG: Controlled group, | PMC9951417 | ||
Changes in outcomes in patients | Table
Changes in Outcome scores#: Difference between 6months and baseline, DAI-10: Drug Attitude Inventory-10, PHR-9:Patient Health Questionnaire-9, EQ-5D-5 L: Euro Qual 5 Dimensions 5 Level | PMC9951417 | ||
Effect of each variable on the amount of change in the DAI-10 | REGRESSION | A multiple regression analysis was performed using a stepwise method with the change in DAI-10 as the dependent variable and PHQ-9, EQ-5D, patient satisfaction, as independent variables. As a result, only the change in patient satisfaction (standardized coefficient β: 0.450, p = 0.024) was included in the model. The ad... | PMC9951417 | |
Pharmacist attributes | Five pharmacists in IG and three pharmacists in CG provided patient care in this study and responded to the questionnaire for pharmacists. 60.0% of the IG and 33.3% of the CG were female. The mean years of experience as a pharmacist was 10.1 for the intervention group and 3.3 for the control group (p = 0.20). | PMC9951417 | ||
Changes in outcomes in pharmacists | depression, Depression | Post-baseline changes in the participating pharmacists’ self-reported confidence in interacting with patients with depression were analyzed, and the results are summarized in Table
Changes in Study Pharmacists’ Self-Reported Confidence in Interacting With Patients With Depression (PCMCD Score)#: Difference between 6mo... | PMC9951417 | |
Discussion | panic disorder, insomnia, depressed, unipolar depression, depressive symptoms, depression | RECURRENCE, DISEASE, DISORDERS, SECONDARY, REGRESSION | This study suggested the possibility that community pharmacists can help improve the medication adherence of patients with unipolar depression by providing CBT-based medication support. This possibility is probably associated with intervention-induced changes in the patients’ perceptions of medication and health care p... | PMC9951417 |
Acknowledgements | The authors thank the pharmacists at the Apis Pharmacy Corporation, Osaka, Japan, for their contributions to this study. | PMC9951417 | ||
Authors’ contributions | MS was responsible for the planning, designing, and management of the study and drafting the manuscript. HM, KT, and FW conducted the training course for the study pharmacists, provided advice and guidance regarding the study design, and reviewed the manuscript. AF and YI selected the study pharmacies, supported the co... | PMC9951417 | ||
Funding | This study was financially supported by the Health Care Science Institute, Tokyo, Japan. | PMC9951417 | ||
Data availability | The datasets used and/or analysed during the current study available from the corresponding author on reasonable request. | PMC9951417 | ||
Declarations | PMC9951417 | |||
Competing interests | The authors have no conflicts of interest to declare. | PMC9951417 | ||
Ethics approval and consent to participate | This study was approved prior to initiation by the Research Ethics Committee of the Osaka University of Pharmaceutical Sciences (Currently, Faculty of Pharmacy, Osaka Medical and Pharmaceutical University; The approval ID: 0063). All methods were carried out in according with the Ethical Guidelines for Medical and Heal... | PMC9951417 | ||
Informed consent | We obtained informed consent from all participants or, if the participants were under 20, from a parent or legal guardian. | PMC9951417 | ||
Consent for publication | Not applicable. | PMC9951417 | ||
References | PMC9951417 | |||
Objective | T2DM | TYPE 2 DIABETES | Basal insulin glargine has a neutral effect on cardiovascular risk in type 2 diabetes (T2DM). In practice, basal insulin is often paired with a glucagon-like peptide-1 receptor agonist (GLP1-RA) or meal insulin; however, the cardiovascular implications of these combinations have not been fully elucidated. In this conte... | PMC9998007 |
Methods | T2DM | REACTIVE HYPEREMIA | In this 20-week trial, adults with T2DM of < 7-years duration were randomized to 8-weeks treatment with (i) insulin glargine (Glar), (ii) glargine + thrice-daily lispro (Glar/Lispro), or (iii) glargine + twice-daily exenatide (Glar/Exenatide), followed by 12-weeks washout. At baseline, 8-weeks, and washout, fasting end... | PMC9998007 |
Results | SE | At baseline, there were no differences in blood pressure (BP), heart rate (HR) or RHI between participants randomized to Glar (n = 24), Glar/Lispro (n = 24), and Glar/Exenatide (n = 25). At 8-weeks, Glar/Exenatide decreased systolic BP (mean − 8.1 mmHg [95%CI − 13.9 to − 2.4], p = 0.008) and diastolic BP (mean − 5.1 mm... | PMC9998007 | |
Keywords | PMC9998007 | |||
Introduction | diabetes | TYPE 2 DIABETES, TYPE 2 DIABETES, REMISSION, DIABETES | The 2008 Food and Drug Administration (FDA) guidance requiring ascertainment of the cardiovascular safety of new glucose-lowering medications has launched an era in which the vascular implications of diabetes therapies are fundamental considerations in the management of type 2 diabetes (T2DM)[In the recently-reported P... | PMC9998007 |
Methods | T2DM | PREVAIL was a 20-week, open-label, parallel-arm trial wherein patients aged 30–80 years with T2DM of ≤ 7 years duration were randomized (1:1:1) to 8-weeks treatment with insulin glargine, glargine + thrice-daily lispro, or glargine + twice-daily exenatide, followed by 12-weeks washout. The study protocol and primary ou... | PMC9998007 | |
Intervention | T2DM | The study intervention has been described in detail [Glargine, administered at bedtime, with doses titrated to target fasting glucose ≤ 5.3 mmol/l;Glargine at bedtime with thrice-daily pre-meal lispro, with doses titrated to target fasting glucose ≤ 5.3 mmol/l and 2-h postprandial glucose < 8 mmol/l;Glargine at bedtime... | PMC9998007 | |
Vascular measures | PAT | At each of the study visits at baseline, 4-weeks, 8-weeks and washout, heart rate and blood pressure were measured in a seated position, after 10 min of rest, with an automated blood pressure monitor. Two measurements were performed 10 min apart, with the average recorded. At the study visits at baseline, 8-weeks and w... | PMC9998007 | |
Statistical analyses | SE | Statistical analyses were conducted with R 4.2.1 and on an intention-to-treat basis. Two-tailed Baseline characteristics of the 3 treatment groups: (i) glargine, (ii) glargine + lispro, and (iii) glargine + exenatideContinuous variables are presented as mean followed by standard deviation in parentheses (if normal dist... | PMC9998007 | |
Results | Table Figure Mean fasting capillary glucose on self-monitoring during each week of therapy in the 3 treatment arms (data are presented as mean with standard error)Vascular measures in each of the treatment arms during the trial: | PMC9998007 | ||
Discussion | stroke, vascular disease, T2DM | STROKE, EVENTS, VASCULAR DISEASE, DYSFUNCTION | In this study, 8-weeks of glargine/exenatide combination therapy decreased BP in patients with T2DM of modest duration, without inducing significant changes in heart rate or RHI. Notably, there were no differences in baseline-adjusted RHI between glargine alone, glargine + lispro and glargine + exenatide after the 8-we... | PMC9998007 |
Acknowledgements | RR holds the Boehringer Ingelheim Chair in Beta-cell Preservation, Function and Regeneration at Mount Sinai Hospital. RR is guarantor and had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. | PMC9998007 | ||
Author contributions | JP | RR and BZ designed the study. RR, AE, CKK and BZ implemented the study and acquired the data. RR led study implementation. AE oversaw research coordination. JP and CY performed the statistical analyses. RR wrote the manuscript. All authors contributed to interpretation of the data and critical revision of the manuscrip... | PMC9998007 | |
Funding | Diabetes | HEART, BEST, DIABETES | This study was supported by the Canadian Institutes of Health Research (CIHR) (MOP 136938) and the University of Toronto Faculty of Medicine, Banting and Best Diabetes Centre and Heart & Stroke/Richard Lewar Centre of Excellence in Cardiovascular Research. | PMC9998007 |
Availability of data and materials | De-identified data can be made available under restricted access from the corresponding author, for academic purposes, subject to a material transfer agreement and approval of the Mount Sinai Hospital Research Ethics Board. | PMC9998007 | ||
Declarations | PMC9998007 | |||
Ethics approval and consent to participate | The study was approved by the Mount Sinai Hospital Research Ethics Board and registered at ClinicalTrials.Gov (NCT02194595). All participants provided written informed consent. | PMC9998007 | ||
Competing interests | RR reports grants from Boehringer Ingelheim, grants and personal fees from Novo Nordisk, personal fees from Sanofi, personal fees from Eli Lilly, outside the submitted work. CKK reports research support from Boehringer Ingelheim, outside the submitted work. All other authors declare no competing interests. | PMC9998007 | ||
References | PMC9998007 | |||
Background | hypertension | HYPERTENSION | Telemedicine is becoming integral in primary care hypertension management, and is associated with improved blood pressure control, self-management and cost-effectiveness. This study explored the experiences of patients and healthcare professionals and their perceived barriers and facilitators in implementing and using ... | PMC10018584 |
Methods | Hypertension | HYPERTENSION | This was a qualitative study embedded within the Primary Technology-Enhanced Care Hypertension pilot trial. Patients were selected purposively and invited to participate by telephone; healthcare professionals involved in the trial were invited to participate by email. Individual semi-structured interviews were conducte... | PMC10018584 |
Results | anxiety | Several emergent themes were identified. The factors involved in the implementation and use of the intervention are complex and interdependent. Patients and healthcare professionals liked the convenience resulting from the intervention and saw an improvement in the patient-provider relationship. Patients appreciated th... | PMC10018584 | |
Conclusions | hypertension | HYPERTENSION | The implementation and use of telemedicine for hypertension management can engender various benefits and challenges to patients, healthcare professionals and the healthcare system. Stakeholder feedback gathered on the sociotechnical aspects of the technology should be taken into consideration to guide the design, imple... | PMC10018584 |
Trial registration | This study was registered on ClinicalTrials.gov on October 9, 2018. ID: NCT03698890. | PMC10018584 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12875-023-02014-8. | PMC10018584 | ||
Keywords | PMC10018584 | |||
Background | hypertension, Hypertension, chronic disease | CARDIOVASCULAR DISEASES, CHRONIC DISEASES, HYPERTENSION, HYPERTENSION, CHRONIC DISEASE | Hypertension is one of the most prevalent chronic diseases in Singapore, affecting 35.5% of adults aged between 18 and 74 years old [Besides lifestyle modifications and pharmacological treatment if indicated, telemedicine has increasingly been considered as an integral part of hypertension management in primary care to... | PMC10018584 |
Methods | PMC10018584 | |||
Recruitment of interview participants | To capture a range of experiences of implementing and using the intervention, the research team identified HCPs who were involved in the implementation and patients who had remained in the trial to participate in the current study. Twenty patients were selected purposively and invited by telephone, and a maximum variat... | PMC10018584 | ||
Data collection | Individual semi-structured interviews were chosen to elicit participant thoughts and feelings about the implementation of the BP telemonitoring intervention [All participants provided written consent for this study. The interviews were conducted face-to-face with each participant between March and September 2019, each ... | PMC10018584 | ||
Analysis | SHT | STS | Each transcript was checked for accuracy against the recording. Data analysis was conducted following the framework method [Two investigators (SHT and EALC) read and re-read the transcripts independently to familiarize with the data and independently coded the data. SHT is a research fellow with a master’s degree in pu... | PMC10018584 |
Results | STS | Thirteen patients and eight HCPs were enrolled into the current study. Participant characteristics are shown in Tables Participant characteristics: Patients (Participant characteristics: Staff (We reported our key findings classified into themes presented by the applicable STS dimensions. The emergent codes, categories... | PMC10018584 | |
Hardware and software | PMC10018584 | |||
Usability and functionality | INTERACTION | Six patients commented that the devices were fast and easy to use, with clear indications and instructions by the care team. Four patients were below 50 years old, two were above 60 years old, and all were in full-time or part-time employment.Nevertheless, patients encountered technical challenges with the devices. Fou... | PMC10018584 | |
Clinical content | PMC10018584 | |||
Availability of records | The transmitted BP readings were only accessible through the web-based clinical management portal by the HCPs, and patients did not know how to retrieve the history from the BP monitor. Therefore, F096 and F099 kept their own record through methods such as taking a video or photo of the readings displayed on the monito... | PMC10018584 | ||
Human–computer interface | PMC10018584 | |||
Usability of clinical management portal | WASTED | The care coordinators and care managers who regularly used the portal for enrolling patients and monitoring patients’ BP noted that its functions and interface were manual and not user-friendly. This slowed their work down and they took some time to adapt to it, affecting the feasibility of the intervention.
Not the ea... | PMC10018584 | |
People | PMC10018584 | |||
Impact on users | The participants described the emotional to physical to behavioral impact that they experienced since they started using the intervention. | PMC10018584 | ||
Caused technology anxiety | anxiety | Three patients, who were above 60 years old and were retired or working part-time, described how they became more anxious since participating in the trial. Their concerns were—afraid to see high BP readings, errors with transmission of readings, unable to reach polyclinic hotline, and found it a chore to remember to me... | PMC10018584 | |
Personal schedules | Most patients and HCPs appreciated the convenience brought about by the intervention. It saved patients’ clinic visits, travelling and waiting time, especially for the working individuals. They could also monitor at a time that suited their schedules. Patients recounted that they no longer had to record BP readings man... | PMC10018584 | ||
Behavior change | hypertension | HYPERTENSION | Six patients, mostly working individuals, reported that the intervention had helped instill a habit, routine and discipline of measuring BP regularly, which would otherwise not be possible even if they had owned a BP monitor.Even though you can buy [a BP monitor], you don't have the discipline to check, but with this t... | PMC10018584 |
Patient profile | stroke, hearing difficulties | STROKE | The participants identified the patient profiles that are more suitable for the intervention than others. These include personal schedules, adaptability, age and digital literacy, health literacy and social support, and physical condition. They felt that the intervention would be more appropriate for certain individual... | PMC10018584 |
Workflow and communication | PMC10018584 | |||
Communication process | The participants discussed several aspects of the intervention relating to internal workflows and engagement between patients and HCPs. | PMC10018584 | ||
Workload management | Through the intervention, HCPs could receive patients’ BP readings remotely and conduct phone medication titration quickly if warranted. This raised conflicting views from HCPs about the impact on their workload.In the initial stages of the trial, S005 (female, care manager) had to “find pockets of time” to check each ... | PMC10018584 | ||
Patient-provider engagement | The patients and HCPs reflected on the engagement between each other relating to the relationship built and support provided during the intervention.Patients reported a sense of security, as they knew that they were being monitored closely by the healthcare team, who would alert them of any irregular or missing BP read... | PMC10018584 | ||
Organizational policies and culture | PMC10018584 | |||
Internal policy | RECRUITMENT | HCPs interviewed, especially the care managers and care coordinators, were concerned about the limited manpower and time available, which would also affect the workload of the intervention. They wondered whether adjustments to internal allocation of resources would be possible in order for the intervention to sustain.
... | PMC10018584 | |
Discussion | STS | The purpose of this study was to assess the barriers and facilitators to the implementation and use of the PTEC-HT BP telemonitoring system with teleconsultation, to inform future expansion of the intervention. Our analysis showed that the technical, human, workflow and organizational factors involved were complex and ... | PMC10018584 | |
Comparison with prior work | The themes that emerged from the current study were largely consistent with the literature which reported that technological usability, reduction of in-office visits, positive impact on self-management and improved patient-provider relationship were the most frequently reported facilitators for adoption of telemedicine... | PMC10018584 | ||
Hardware and software, human–computer interface, people | diabetes | HYPERTENSION, DIABETES | Our study participants found the intervention easy-to-use, and patients could save time travelling to and waiting in the hectic polyclinic setting, or recording BP readings manually. HCPs also had quicker access to BP readings and could conduct teleconsultation, if necessary, thereby improving their efficiency. Fletche... | PMC10018584 |
Clinical content, people | Patients in the current study wished to have access to their data for sharing with other HCPs or self-management, and some form of feedback or advice even if their readings were satisfactory. These could encourage them to become more engaged as active managers of their healthcare thereby facilitating self-management.Ho... | PMC10018584 | ||
People | anxiety | There was variability in the use of the intervention by certain populations in this study. Older patients experienced technology anxiety as they were afraid to see abnormal readings or were worried that the readings did not get transmitted. They also preferred face-to-face consultations possibly for the human connectio... | PMC10018584 | |
Workflow and communication, people, organizational policies and culture | confusion, anxiety | WEST | Whereas patients and HCPs were reported to be concerned about telemedicine hindering the patient-provider relationship [While other studies mainly focused on the doctor as the provider of the intervention, team-based care was provided at the polyclinic as teamlets. However, one patient experienced confusion as there wa... | PMC10018584 |
Strengths and limitations | STS | This study was conducted within a quasi-experimental trial using qualitative methodologies. It provided insights into the views of patients and HCPs on the implementation and use of BP telemonitoring system with teleconsultation in a real-world setting. Integration with routine clinical practice and the ability to adap... | PMC10018584 | |
Conclusions | Our study provides comprehensive perspectives on the barriers and facilitators to the implementation and use of a BP telemedicine intervention in a complex fast-paced primary care setting. It can engender various benefits and challenges to patients, healthcare professionals and the healthcare system. An intervention th... | PMC10018584 | ||
Acknowledgements | RECRUITMENT | The research team are very grateful to the staff who helped with patient recruitment and study logistics, particularly Ms Nur Atiqah Binte Surya Akmaja. We would also like to thank all patients and healthcare professionals who participated in this study, and Dr Tam Chen Hee for his guidance. | PMC10018584 | |
Authors’ contributions | All authors contributed to the study design and data interpretation. SHT and EALC conducted the interviews and analyzed the qualitative data. SHT wrote the first draft of the manuscript and revisions based on comments from other authors. EALC made substantial contributions to revisions of the manuscript. VHYT, DWLN, WE... | PMC10018584 | ||
Funding | TRANSFORMATION | The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Ministry of Health Office for Healthcare Transformation, and the Ministry of Health's National Medical Research Council under the Centre Grant Programme (Ref ... | PMC10018584 | |
Availability of data and materials | The data generated and/or analyzed are available upon reasonable request. The data request can be sent to Clinical Research Unit, National Healthcare Group Polyclinics, Singapore; Email address: NHGP_CRU@nhgp.com.sg. | PMC10018584 | ||
Declarations | PMC10018584 | |||
Ethics approval and consent to participate | This study was approved by the National Healthcare Group Domain Specific Review Board (Reference number: 2018/00785). All participants provided informed consent to participate in the interviews. | PMC10018584 | ||
Consent for publication | This is not applicable as this manuscript does not contain data from any individual person. All participants in this study were de-identified and given participant ID. | PMC10018584 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10018584 | ||
References | PMC10018584 | |||
Background | Comprehensive Geriatric Assessment (CGA)is a widely accepted intervention for frailty and can be cost-effective within a primary care setting. | PMC10463370 | ||
Objective | To explore the feasibility of identifying older adults with frailty and assess the subsequent implementation of a tailored CGA with care and support plan by Advanced Nursing Practitioners (ANPs). | PMC10463370 | ||
Methods | A mixed-method parallel randomised controlled trial was conducted. Participants were recruited from two General Practice (GP) centres between January and June 2019. Older adults with confirmed frailty, as assessed by practice nurses, were randomised, using a web service, to the intervention or treatment-as-usual (TAU) ... | PMC10463370 | ||
Results | One hundred sixty four older adults were invited to participate, of which 44.5% ( | PMC10463370 | ||
Discussion | Frailty | Frailty identification and intervention delivery in the community by ANPs were feasible. The study shows that older adults with frailty living in the community might benefit from intervention delivered by ANPs. It is suggested to examine the cost-effectiveness of the intervention in sufficiently powered future research... | PMC10463370 | |
Trial registrations | The protocol is available at clinicaltirals.gov, ID: NCT03394534; 09/01/2018. | PMC10463370 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12877-023-04218-0. | PMC10463370 | ||
Keywords | PMC10463370 | |||
Background | Frailty | RECRUITMENT, EMERGENCY | The number of people over the age of 85 has nearly doubled in the past three decades and it is estimated that by 2030 one in five people in England will be over the age of 65 [Comprehensive Geriatric Assessment (CGA) offers holistic multidisciplinary care for older adults with frailty. CGA takes into account various as... | PMC10463370 |
Methods | PMC10463370 | |||
Design | BLIND, STILL | A mixed-methods parallel randomised controlled trial design with an equal randomisation ratio, stratified based on level of frailty, was conducted. No sample size calculation was performed for this trial. Still, it was estimated that 160 people with frailty would be included based on the resource available and the numb... | PMC10463370 | |
Participants’ screening and eligibility | To be included in the study, patients had to be assessed by a practice nurse and show mild, moderate, or severe levels of frailty. Between January and June 2019, administrative staff at two GP centres in Belper, UK, screened patients’ health records to identify potential eligible candidates for assessment. They invited... | PMC10463370 | ||
Intervention | Two ANPs, specialising in the health and care of older adults, adopted a holistic, biopsychosocial approach to assessing participants at their homes or the GP centres depending on individual participants’ convenience. A CGA proforma with sections on detailed assessment strategy, matters important to participants, refer... | PMC10463370 | ||
Data collection | RS | SECONDARY | Data were collected at baseline and six months post-intervention from both CGA & CSP and TAU groups. Baseline data collection was conducted by practice nurses at participants' homes. A research nurse collected Post-intervention data over the phone (please see section ‘Deviation from protocol’). A data collection form c... | PMC10463370 |
Feasibility, retention, and dropouts | RECRUITMENT |
Response rate: percentage of the participants willing to participate who were eligible based on the eFI score.Eligibility rate: percentage of consented participants eligible who entered the study based on nurses’ clinical frailty diagnosis.Recruitment rate: percentage of invited participants who were eligible and rand... | PMC10463370 | |
Secondary outcomes | SECONDARY | The secondary outcomes included:Hospital and nursing home admissions during the past six months recalled by the study participants. This outcome was considered the proposed primary outcome of a future trial.Participants reported numbers of 999 calls, A&E attendances, GP Centre or GP Centre out-of-office calls and atten... | PMC10463370 |
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