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A randomized trial of a mobile health intervention to augment cardiac rehabilitation
Golbus JR, Gupta K, Stevens R, Jeganathan VSE, Luff E, Shi J, Dempsey W, Boyden T, Mukherjee B, Kohnstamm S, Taralunga V, Kheterpal V, Murphy S, Klasnja P, Kheterpal S, Nallamothu BK
NPJ Digital Medicine 2023 Sep 14;6(173):Epub
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

Mobile health (mHealth) interventions may enhance positive health behaviors, but randomized trials evaluating their efficacy are uncommon. Our goal was to determine if a mHealth intervention augmented and extended benefits of center-based cardiac rehabilitation (CR) for physical activity levels at 6 months. We delivered a randomized clinical trial to low and moderate risk patients with a compatible smartphone enrolled in CR at two health systems. All participants received a compatible smartwatch and usual CR care. Intervention participants received a mHealth intervention that included a just-in-time-adaptive intervention (JITAI) as text messages. The primary outcome was change in remote 6 minute walk distance at 6 months stratified by device type. Here we report the results for 220 participants enrolled in the study (mean (SD) age 59.6 (10.6) years; 67 (30.5%) women). For our primary outcome at 6 months, there is no significant difference in the change in 6 min walk distance across smartwatch types (Intervention versus control +31.1 meters Apple Watch, -7.4 meters Fitbit; p = 0.28). Secondary outcomes show no difference in mean step counts between the first and final weeks of the study, but a change in 6 min walk distance at 3 months for Fitbit users. Amongst patients enrolled in center-based CR, a mHealth intervention did not improve 6 month outcomes but suggested differences at 3 months in some users.

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