Testing the Recruitment Frequency, Implementation Fidelity, and Feasibility of Outcomes of the Heart Failure Activity Coach Study (HEALTHY): Pilot Randomized Controlled Trial.

backgroundHeart failure (HF) is a common and deadly disease, precipitated by physical inactivity and sedentary behavior. Although the 1-year survival rate after the first diagnosis is high, physical inactivity and sedentary behavior are associated with increased mortality and negatively impact the health-related quality of life (HR-QoL).

objectiveWe tested the recruitment frequency, implementation fidelity, and feasibility of outcomes of the Activity Coach app that was developed using an existing mobile health (mHealth) tool, Optilogg, to support older adults with HF to be more physically active and less sedentary.

methodsIn this pilot clinical randomized controlled trial (RCT), patients with HF who were already using Optilogg to enhance self-care behavior were recruited from 5 primary care health centers in Sweden. Participants were randomized to either have their mHealth tool updated with the Activity Coach app (intervention group) or a sham version (control group). The intervention duration was 12 weeks, and in weeks 1 and 12, the participants wore an accelerometer daily to objectively measure their physical activity. The HR-QoL was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), and subjective goal attainment was assessed using goal attainment scaling. Baseline data were collected from the participants' electronic health records (EHRs).

resultsWe found 67 eligible people using the mHealth tool, of which 30 (45%) initially agreed to participate, with 20 (30%) successfully enrolled and randomized to the control and intervention groups in a ratio of 1:1. The participants' daily adherence to registering physical activity in the Activity Coach app was 69% (range 24%-97%), and their weekly adherence was 88% (range 58%-100%). The mean goal attainment score was -1.0 (SD 1.1) for the control group versus 0.6 (SD 0.6) for the intervention group (P=.001). The mean change in the overall HR-QoL summary score was -9 (SD 10) for the control group versus 3 (SD 13) in the intervention group (P=.027). There was a significant difference in the physical limitation scores between the control (mean 45, SD 27) and intervention (mean 71, SD 20) groups (P=.04). The average length of sedentary bouts increased by 27 minutes to 458 (SD 84) in the control group minutes and decreased by 0.70 minutes to 391 (SD 117) in the intervention group (P=.22). There was a nonsignificant increase in the mean light physical activity (LPA): 146 (SD 46) versus 207 (SD 80) minutes in the control and intervention groups, respectively (P=.07).

conclusionsThe recruitment rate was lower than anticipated. An active recruitment process is advised if a future efficacy study is to be conducted. Adherence to the Activity Coach app was high, and it may be able to support older adults with HF in being physically active.

trial registrationClinicalTrials.gov NCT05235763; https://clinicaltrials.gov/study/NCT05235763.