Key result
The PATHway home-based cardiac rehabilitation program maintained physical activity levels, whereas they deteriorated in usual care (effect size -0.36; P=0.004).
Why the study?
Cardiac rehabilitation uptake and long-term adherence remain suboptimal, prompting the need for innovative strategies such as remotely monitored home-based programs.
Does a technology-enabled, remotely monitored, home-based cardiac rehabilitation program improve physical activity in CVD patients during phase III cardiac rehabilitation?
RCT
Single-blind
1:1
Yes
Does a technology-enabled, remotely monitored, home-based cardiac rehabilitation program improve physical activity in CVD patients during phase III cardiac rehabilitation?
Standardized Mean Difference: -0.36
p-value: p=0.004
A technology-enabled, remotely monitored, home-based cardiac rehabilitation program is feasible, acceptable, and may prevent the deterioration of physical activity seen with usual care.
Supports further development of home-based cardiac rehab; leaves open efficacy confirmation in definitive trials.
BACKGROUND: Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVDs). Uptake of CR remains suboptimal (30% of eligible patients), and long-term adherence to a physically active lifestyle is even lower. Innovative strategies are needed to counteract this phenomenon. OBJECTIVE: The Physical Activity Toward Health (PATHway) system was developed to provide a comprehensive, remotely monitored, home-based CR program for CVD patients. The PATHway-I study aimed to investigate its feasibility and clinical efficacy during phase III CR. METHODS: Participants were randomized on a 1:1 basis to the PATHway (PW) intervention group or usual care (UC) control group in a single-blind, multicenter, randomized controlled pilot trial. Outcomes were assessed at completion of phase II CR and 6-month follow-up. The primary outcome was physical activity (PA; Actigraph GT9X link). Secondary outcomes included measures of physical fitness, modifiable cardiovascular risk factors, endothelial function, intima-media thickness of the common carotid artery, and quality of life. System usability and patients' experiences were evaluated only in PW. A mixed-model analysis of variance with Bonferroni adjustment was used to analyze between-group effects over time. Missing values were handled by means of an intention-to-treat analysis. Statistical significance was set at a 2-sided alpha level of .05. Data are reported as mean (SD). RESULTS: =.004; effect size of -0.36) remained constant, but deteriorated in UC. CONCLUSIONS: This pilot study demonstrated the feasibility and acceptability of a technology-enabled, remotely monitored, home-based CR program. Although clinical effectiveness was demonstrated, several challenges were identified that could influence the adoption of PATHway. TRIAL REGISTRATION: ClinicalTrials.gov NCT02717806; https://clinicaltrials.gov/ct2/show/NCT02717806. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2017-016781.
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Claes et al. (2019) conducted an RCT in Cardiovascular diseases. PATHway system (remotely monitored, home-based cardiac rehabilitation) vs. Usual care was evaluated on Physical activity (effect size -0.36, p=0.004). The PATHway home-based cardiac rehabilitation program maintained physical activity levels, whereas they deteriorated in usual care (effect size -0.36; P=0.004).