Hiemstra Madison S, Reichert Sonja M, Mitchell Marc S
School of Kinesiology, Western University, London, ON, Canada.
Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
JMIR Form Res. 2024 Jan 29;8:e46418. doi: 10.2196/46418.
To date, most group-based diabetes self-management education (DSME) programs for type 2 diabetes (T2D) have been delivered in person. The rapid transition to remote care at the outset of the COVID-19 pandemic presented opportunities to test, evaluate, and iterate a new remote DSME program.
We aim to refine the delivery and evaluation of a multicomponent remote DSME program for adults living with T2D by examining several feasibility outcomes.
We recruited a convenience sample of patients from a London, Canada, outpatient diabetes clinic (serving high-risk, low-income adults) to participate in a 6-week, single cohort feasibility study from November 2020 to March 2021. This small ORBIT phase 1b feasibility study represents the first in a planned series guided by the ORBIT model for developing behavioral interventions for chronic diseases (phase 1: design; phase 2: preliminary testing; phase 3: efficacy; and phase 4: effectiveness). The feasibility of delivering and evaluating a remote DSME program, including (1) live video education classes, (2) individualized physical activity (PA) prescription and counseling, and (3) intermittently scanned continuous glucose and wearable PA monitoring, was assessed. Feasibility outcomes included recruitment and retention rates, program adherence, and acceptability (ie, technology issues and exit survey feedback). PA was assessed with Fitbit Inspire 2 (Fitbit Inc) and estimated glycated hemoglobin (HbA) using the FreeStyle Libre (Abbot). Given the small study sample, group- and individual-level data are reported descriptively.
A total of 10 adults living with T2D were recruited (female 60%; age 49.9, SD 14.3 years; estimated HbA 6.2%, SD 0.5%). Recruitment and retention rates were 29% and 80%, respectively. Participants attended 83% (25/30) and 93% (37/40) of education classes and PA counseling phone calls, respectively. There were 3.2 (SD 2.6) technology issues reported per person, most of which were related to study data transfer. Exit survey responses suggest most participants (8/9, 89%) were "satisfied" with the program. Recognizing the small sample size and the fact that no inferential statistics were conducted, the mean (SD) for the weekly daily step count and estimated HbA are provided for illustrative purposes. Participants accumulated 7103 (SD 2900) and 7515 (SD 3169) steps per day at baseline and week 6, respectively. The estimated HbA was 6.2% (SD 0.5%) and 6.2% (SD 0.6%) at baseline and week 6, respectively.
This ORBIT phase 1b study served to refine the delivery (eg, automatic study data upload process recommended to reduce participant burden) and evaluation (eg, purposeful sampling of participants with baseline HbA >8% recommended to address selection bias) of a remote DSME program. Preliminary proof-of-concept testing (ORBIT phase 2) incorporating some of these learnings is now warranted.
ClinicalTrials.gov NCT04498819; https://clinicaltrials.gov/study/NCT04498819.
迄今为止，大多数针对2型糖尿病（T2D）的基于群体的糖尿病自我管理教育（DSME）项目都是面对面开展的。在2019冠状病毒病大流行初期迅速向远程护理过渡，为测试、评估和迭代新的远程DSME项目提供了机会。
我们旨在通过研究几个可行性结果，完善针对患有T2D的成年人的多组分远程DSME项目的实施和评估。
我们从加拿大伦敦一家门诊糖尿病诊所（服务高危、低收入成年人）招募了一个便利样本的患者，于2020年11月至2021年3月参加一项为期6周的单队列可行性研究。这项小型的ORBIT 1b期可行性研究是计划系列研究中的第一项，该系列研究由ORBIT模型指导，用于开发慢性病行为干预措施（第1阶段：设计；第2阶段：初步测试；第3阶段：疗效；第4阶段：有效性）。评估了实施和评估远程DSME项目的可行性，包括（1）实时视频教育课程、（2）个性化体育活动（PA）处方和咨询，以及（3）间歇性扫描的连续血糖和可穿戴PA监测。可行性结果包括招募率和保留率、项目依从性和可接受性（即技术问题和退出调查反馈）。使用Fitbit Inspire 2（Fitbit公司）评估PA，并使用FreeStyle Libre（雅培公司）估计糖化血红蛋白（HbA）。鉴于研究样本量小，以描述性方式报告组级和个体级数据。
共招募了10名患有T2D的成年人（女性占60%；年龄49.9岁，标准差14.3岁；估计HbA为6.2%，标准差0.5%）。招募率和保留率分别为29%和80%。参与者分别参加了83%（25/30）的教育课程和93%（（37/40）的PA咨询电话。每人报告有3.2个（标准差2.6）技术问题，其中大多数与研究数据传输有关。退出调查回复表明，大多数参与者（8/9，89%）对该项目“满意”。鉴于样本量小且未进行推断统计，提供了每日步数均值（标准差）和估计HbA以作说明。参与者在基线时和第6周时每天分别积累7103步（标准差2900）和7515步（标准差3169）。基线时和第6周时估计HbA分别为6.2%（标准差0.5%）和6.2%（标准差0.6%）。
这项ORBIT 1b期研究有助于完善远程DSME项目的实施（例如，建议采用自动研究数据上传流程以减轻参与者负担）和评估（例如，建议对基线HbA>8%的参与者进行有目的抽样以解决选择偏倚）。现在有必要进行纳入这些经验教训的初步概念验证测试（ORBIT第2阶段）。
ClinicalTrials.gov NCT04498819；https://clinicaltrials.gov/study/NCT04498819 。
