Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Apr 1, 2019
Open Peer Review Period: Apr 1, 2019 - May 27, 2019
Date Accepted: Oct 1, 2019
(closed for review but you can still tweet)
PATHway-I: Feasibility, acceptability and clinical effectiveness of a technology enabled cardiac rehabilitation platform. A randomized controlled trial.
ABSTRACT
Background:
Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVD). Uptake of CR remains suboptimal (30% of eligible patients) and long-term adherence to a physically active (PA) lifestyle is even lower. Innovative strategies are needed to counteract this phenomenon.
Objective:
We developed the PATHway system (Physical Activity Towards Health) 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 intervention group (PW) or usual care control group (UC) in a Single-blind, multicenter, randomized controlled pilot trial. Outcomes were assessed at completion of phase II CR and six months follow-up. The primary outcome was 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 ANOVA 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 two-sided alpha level of 0.05. Data are reported as mean ± SD.
Results:
A convenience sample of 120 CVD patients (61.4 ± 13.5 years, 22 women) was included. The PATHway system was deployed in the homes of 60 participants. System use decreased over time and system usability was average with a score of 65.7 ± 19.7 (range 5-100). Moderate to vigorous intensity PA increased in PW (PW: 127 ± 58 min to 141 ± 69 min, UC: 146 ± 66 min to 143 ± 71 min; p-interaction=0.039), while diastolic blood pressure (PW: 79 ± 11 to 79 ± 10 mmHg, UC: 78 ± 9 to 83 ± 10 mmHg; p-interaction=0.004) and cardiovascular risk score remained constant, but deteriorated in UC (PW: 15.9 ± 10.4 to 15.5 ± 10.5%, UC: 14.5 ± 9.7 to 15.7 ± 10.9%; p-interaction=0.004).
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 adoption of PATHway. Clinical Trial: This trial was registered at www.clinicaltrials.gov: NCT02717806
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