Impact of a comprehensive digital health programme on HbA1c and weight after 12 months for people with diabetes and prediabetes: a randomised controlled trial

Abstract

Aims/hypothesis The aim of this RCT was to evaluate the effectiveness of a digital health programme (BetaMe/Melon) vs usual care in improving the control of type 2 diabetes and prediabetes in a primary care population. Methods We conducted a randomised parallel-group two-arm single-blinded superiority trial in the primary care setting in two regions of New Zealand. Eligible participants were identified through Primary Health Organisations and participating practices. Eligibility criteria were as follows: age 18-75 years, HbA 1c 41-70 mmol/mol (5.9-8.6%), not taking insulin, and daily access to the internet. BetaMe/Melon is a 12 month mobile-device and web-based programme with four components: health coaching; evidence-based resources; peer support; and goal tracking. Participants were randomised into the intervention or control arm (1:1 allocation) based upon baseline HbA 1c (prediabetes or diabetes range), stratified by practice and ethnicity. Research nurses and the study biostatistician were blind to study arm. Primary outcomes of the study were changes in HbA 1c and weight at 12 months, using an intention-to-treat analysis. Results Four hundred and twenty-nine individuals were recruited between 20 June 2017 and 11 May 2018 (n = 215 intervention arm, n = 214 control arm), most of whom were included in analyses of co-primary outcomes (n = 210/215, 97.7% and n = 213/ 214, 99.5%). HbA 1c levels at 12 months did not differ between study arms: mean difference was −0.9 mmol/mol (95% CI −2.9, 1.1) (−0.1% [95% CI −0.3, 0.1]) for the diabetes group and was 0.0 mmol/mol (95% CI −0.9, 0.9) (0.0% [95% CI −0.1, 0.1]) for the prediabetes group. Weight reduced slightly at 12 months for participants in both study arms, with no difference between arms (mean difference −0.4 kg [95% CI −1.3, 0.5]). Conclusions/interpretation This study did not demonstrate clinical effectiveness for this particular programme. Given their high costs, technology-assisted self-management programmes need to be individually assessed for their effectiveness in improving clinical outcomes for people with diabetes.

Empowering Patients Living With Chronic Conditions Using Video as an Educational Tool: Scoping Review

“…In the 12 studies selected to carried out this study, a total of 1398 participants were included. The sample size of the different studies ranged from 8 participants [ 20 ] to 429 participants [ 21 ], with an average size of 116.5 participants per study. Of the 12 studies, 8 studies included more than 50 subjects.…”

“…Regarding the chronic disease of the participants, the selected studies included participants with diagnoses of chronic obstructive pulmonary disease (COPD; 4/12, 33%) [ 20 , 25 , 29 , 31 ], which was the most frequent; heart failure (2/12, 17%) [ 22 , 23 ]; chronic pain (1/12, 8%) [ 24 ]; diabetes (1/12, 8%) [ 21 ]; or squamous intraepithelial lesion due to human papillomavirus (HPV; 1/12, 8%) [ 26 ]. Participants with any chronic conditions were included in 3 of the studies [ 27 , 28 , 30 ], while quality of life was measured in 25% (3/12) of the studies.…”

“…In other studies, videos were provided in a DVD delivered to the patient independently [ 25 ] or combined with other activities such as videoconference sessions [ 28 ]. Lastly, some studies included an educational video combined with other tools incorporated in a complex platform for telehealth [ 21 , 23 ].…”

“…These studies assessed whether the application of video had improved the management of chronic disease, and successful results were obtained in most cases. Of the 12 studies included in the review, 2 studies [ 21 , 26 ] did not show significant results to support the hypothesis that video is an effective tool to improve the health of patients with chronic disease in the long term. The study carried out by Ketelaars et al [ 26 ] found that the educational video did not significantly reduce the anxiety levels of the participants; that is, it was not effective as a stress reduction tool for women with HPV before a diagnostic procedure, compared with a brochure.…”

“…This checklist is made up of a total of 27 questions classified in 4 domains (reporting, external validity, internal validity, and power). Scores on the modified Downs and Black checklist were classified as "excellent" (score 24-28), "good" (19)(20)(21)(22)(23), "fair" (14)(15)(16)(17)(18), or "poor" (≤13).…”