scholarly journals Recruiting to a Randomized Controlled Trial of a Web-Based Program for People With Type 2 Diabetes and Depression: Lessons Learned at the Intersection of e-Mental Health and Primary Care

10.2196/12793 ◽  
2019 ◽  
Vol 21 (5) ◽  
pp. e12793 ◽  
Author(s):  
Susan Fletcher ◽  
Janine Clarke ◽  
Samineh Sanatkar ◽  
Peter Baldwin ◽  
Jane Gunn ◽  
...  
Keyword(s):  
Mental Health ◽  
Type 2 Diabetes ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Lessons Learned ◽  
Web Based ◽  
Randomized Controlled

scholarly journals Effects of the Proactive Interdisciplinary Self-Management (PRISMA) Program on Online Care Platform Usage in Patients with Type 2 Diabetes in Primary Care: A Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Esther du Pon ◽  
Nanne Kleefstra ◽  
Frits Cleveringa ◽  
Ad van Dooren ◽  
Eibert R. Heerdink ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Self Management ◽  
Online Platform ◽  
Randomized Controlled ◽  
Number Of Patients

Online care platforms can support patients with type 2 diabetes (T2DM) in managing their health. However, in the use of eHealth, a low participation rate is common. The Proactive Interdisciplinary Self-Management (PRISMA) program, aimed at improving patients’ self-management skills, was expected to encourage patients to manage their disease through the use of an online platform. Therefore, the objective of the current study was to investigate whether a group education program can improve the use of an online care platform in patients with T2DM treated by primary care providers in the Netherlands. In a randomized controlled trial, patients with T2DM received either PRISMA with usual care or usual care only. During a six-month follow-up period in 2014-2015, usage (number of log-ons and time spent per session) of an online care platform (e-Vita) aimed at improving T2DM self-management was assessed. A training about the functionalities of e-Vita was offered. The sample consisted of 203 patients. No differences were found between the intervention and control groups in the number of patients who attended the platform training (interested patients) (X21=0.58; p=0.45), and the number of patients who logged on at least once (platform users) (X21=0.46; p=0.50). In addition, no differences were found between the groups in the type of users—patients who logged on twice or more (active users) or patients who logged on once (nonactive users) (X21=0.56; p=0.45). The PRISMA program did not change platform usage in patients with T2DM. In addition, only a small proportion of the patients logged on twice or more. Patients probably need other encouragements to manage their condition using an online platform.

scholarly journals A Highly Tailored Text and Voice Messaging Intervention to Improve Medication Adherence in Patients With Either or Both Hypertension and Type 2 Diabetes in a UK Primary Care Setting: Feasibility Randomized Controlled Trial of Clinical Effectiveness

10.2196/16629 ◽  
2020 ◽  
Vol 22 (5) ◽  
pp. e16629 ◽  
Author(s):  
Aikaterini Kassavou ◽  
Venus Mirzaei ◽  
James Brimicombe ◽  
Simon Edwards ◽  
Efthalia Massou ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Primary Care ◽  
Randomized Controlled Trial ◽  
Medication Adherence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Clinical Effectiveness ◽  
Control Group ◽  
Randomized Controlled

Background The efficacy of a highly tailored digital intervention to support medication adherence and feasibility to support clinical effectiveness as an adjunct to the primary care setting has not been evaluated. Objective This trial aimed to assess the behavioral efficacy of a highly tailored digital intervention to support medication adherence and to evaluate the feasibility of its clinical effectiveness, in patients with either or both hypertension and type 2 diabetes. We also examined quality of life and mechanisms of behavior change. Intervention fidelity, engagement, and satisfaction were also explored. Methods This was a multicenter, individually randomized controlled trial of 2 parallel groups: an intervention group that received a highly tailored text message and interactive voice response intervention for 12 weeks, and a control group that received usual care. Medication adherence was measured using self-reports and assessor-blinded practice records of a repeat prescription. Systolic blood pressure and glucose levels were assessed by nurses blinded to group allocation during practice visits at 3 months follow-up. Questionnaires obtained data to assess intervention mechanisms of action and satisfaction and digital log files captured data to evaluate fidelity and engagement. Results A total of 135 nonadherent patients (62/135, 46% female; 122/135, 90.3%; aged above 50 years) were randomly allocated in the intervention (n=79) or in the control group (n=56); of whom 13% (18/135) were lost at follow-up. Medication adherence was significantly improved in the intervention group compared with the control group (t116=2.27; P=.02, 2-tailed). Systolic blood pressure was 0.6 mmHg (95% CI −7.423 to 6.301), and hemoglobin A1c was 4.5 mmol/mol (95% CI −13.099 to 4.710) lower in the intervention group compared with the control group. Changes in intentional nonadherence and nonintentional nonadherence explained the improvements in medication adherence in the intervention group (beta=.074, SE=0.464; P=.04), but not in the control group (beta=.00, SE 1.35; P=.37). The intervention had 100% fidelity, a median of 12 days of engagement, and 76% overall satisfaction. Conclusions Our trial is the first that has been conducted in the United Kingdom and showed that among nonadherent patients with either or both hypertension and type 2 diabetes, a highly tailored digital intervention was effective at improving treatment adherence and feasible to obtain clinically meaningful outcomes. Changes in intentional and nonintentional nonadherence predicted the improvements in medication adherence. The intervention had high fidelity, engagement, and satisfaction. Future research using a rigorous design is needed to evaluate the clinical effectiveness and cost-effectiveness of the intervention in primary care. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 10668149; http://www.controlled-trials.com/ISRCTN10668149.

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