The Effectiveness of an eHealth Family-Based Intervention Program in Patients With Uncontrolled Type 2 Diabetes Mellitus (T2DM) in the Community Via WeChat: Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Intervention based on family support and risk perception can enhance type 2 diabetes mellitus (T2DM) patients’ self-care activities. In addition, eHealth education is considered to improve family members’ support for patients with T2DM. However, there is little evidence from rigorously designed studies on the effectiveness of an intervention combining these approaches. OBJECTIVE This randomized controlled trial (RCT) aimed to assess the effectiveness of an eHealth family-based health education intervention for patients with T2DM to improve their glucose control, risk perception, and self-care behaviors. METHODS This single-center, 2-parallel-group RCT was conducted between 2019 and 2020. Overall, 228 patients were recruited from Jiading District, Shanghai, and randomly divided into intervention and control groups. The intervention group received an eHealth family intervention based on community management via WeChat, whereas the control group received usual care. The primary outcome was the glycated hemoglobin (HbA<sub>1c</sub>) level of the patients with T2DM, and the secondary outcomes were self-management behavior (general and specific diet, exercise, blood sugar testing, foot care, and smoking), risk perception (risk knowledge, personal control, worry, optimism bias, and personal risk), and family support (supportive and nonsupportive behaviors). A 2-tailed paired-sample <i>t</i> test was used to compare the participants at baseline and follow-up within the control and intervention groups. An analysis of covariance was used to measure the intervention effect. RESULTS In total, 225 patients with T2DM were followed up for 1 year. After intervention, they had significantly lower HbA<sub>1c</sub> values (β=–.69, 95% CI –0.99 to –0.39; <i>P</i><.001). They also had improved general diet (β=.60, 95% CI 0.20 to 1.00; <i>P</i>=.003), special diet (β=.71, 95% CI 0.34 to 1.09; <i>P</i><.001), blood sugar testing (β=.50, 95% CI 0.02 to 0.98; <i>P</i>=.04), foot care (β=1.82, 95% CI 1.23 to 2.42; <i>P</i><.001), risk knowledge (β=.89, 95% CI 0.55 to 1.24; <i>P</i><.001), personal control (β=.22, 95% CI 0.12 to 0.32; <i>P</i><.001), worry (β=.24, 95% CI 0.10 to 0.39; <i>P</i>=.001), optimism bias (β=.26, 95% CI 0.09 to 0.43; <i>P</i>=.003), and supportive behaviors (β=5.52, 95% CI 4.03 to 7.01; <i>P</i><.001). CONCLUSIONS The eHealth family-based intervention improved glucose control and self-care activities among patients with T2DM by aiding the implementation of interventions to improve T2DM risk perceptions among family members. The intervention is generalizable for patients with T2DM using health management systems in community health centers. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR1900020736; https://www.chictr.org.cn/showprojen.aspx?proj=31214