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Effect of voluntary participation on mobile health care in diabetes management: randomized controlled open-label trial
Lee DY, Yoo S-H, Min KP, Park C-Y
JMIR MHealth and UHealth 2020 Sep;8(9):e19153
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: The role of mobile health care (mHealth) in glycemic control has been investigated, but its impact on self-management skills and its psychological aspects have not been studied. OBJECTIVE: We evaluated the efficacy of mHealth-based diabetes self-management education and the effect of voluntary participation on its effects. METHODS: This study was a randomized controlled open-label trial conducted for 6 months at Kangbuk Samsung Hospital. Participants in the control group (n = 31) maintained their previous diabetes management strategies. Participants in the intervention group (n = 41) additionally received mHealth-based diabetes self-management education through a mobile app and regular individualized feedback from health care professionals. The primary outcome was change in glycated hemoglobin (HbA1c) level over 6 months between the 2 groups (intervention versus control) and within each group (at 6 months versus baseline). The secondary outcomes were changes in body mass index, blood pressure, lipid profile, and questionnaire scores (the Korean version of the Summary of Diabetes Self-Care Activities Questionnaire, an Audit of Diabetes Dependent Quality of Life, the Appraisal of Diabetes Scale, and Problem Areas in Diabetes) over 6 months between groups and within each group. RESULTS: A total of 66 participants completed this study. HbA1c (p = 0.04), total cholesterol level (p = 0.04), and Problem Areas in Diabetes scores (p = 0.02) significantly decreased; total diet (p = 0.03) and self-monitoring of blood glucose level scores (p = 0.01), based on the Summary of Diabetes Self-Care Activities Questionnaire, markedly increased within the intervention group. These significant changes were observed in self-motivated participants who were recruited voluntarily via advertisements. CONCLUSIONS: mHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants. TRIAL REGISTRATION: ClinicalTrials.gov NCT03468283; http://ClinicalTrials.gov/ct2/show/NCT03468283.

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