Table 5 Cardiac Rehabilitation Studies
From: Smartphones in the secondary prevention of cardiovascular disease: a systematic review
Publication (Author, Year, Country) | Participants, Sample Size, Rurality and Theoretical Model | mHealth and Non-mHealth Components | Intervention and Comparison | Outcomes |
|---|---|---|---|---|
Worringham, 2011 Australia | Patients with an acute coronary event or revascularisation procedure unable to attend traditional CR Referred patients: n = 7 (1 withdrew prior to initial exercise testing) Intervention: n = 6 (83% M) Metropolitan and rural participants Theoretical model: None | mHealth Programmed smartphone External heart and activity monitor with GPS and Bluetooth connectivity Real-time monitoring of location, speed, heart rate and single lead ECG. Mobile phone contact pre- and post-exercise sessions Emergency mobile phone contact | Non-randomised feasibility trial Comparison group: None 6 week intervention Long-term engagement: recognised as a limitation and need for larger-scale and longer-term studies. Examination of outcomes of an outdoor walking-based exercise program Statistical analysis: Paired t-tests. | Mean age 53.6 (42–67) years Uptake: 86% of referred patients Completion/attrition: 100% completed the 6 week exercise program Usability and adherence: 87% of sessions completed (80% without technical problems), 13% cancelled. Ease of use rated 4.8/5 (95%CI 4.6–5.0) Physical function: 6MWT improved from 524 m to 637 m (p = 0.009). SF36 QOL: Physical Health score increased from 50.0 to 78.4 (p = 0.03) Mental Health improved: Cardiac depression scale reduced from 54.0 to 44.6 (p- = 0.007). SF36 QOL Mental Health score: NS |
Forman, 2014 USA | Patients currently enrolled in Phase 2 CR or recently completed (within 1 month) and continuing with Phase 3 CR. n = 26 (77% M) Metropolitan Hospital Rural patients not reported Theoretical model: None | mHealth iPhone, iPad or iPod touch Heart Coach Application: • Daily messages and tasks • Educational material and videos • Medication reminders • Physical activity prompts • Screenings and surveys Non-mHealth Traditional centre-based phase 2 CR or phase 3 CR (not defined) Qualitative patient and clinician feedback | Observational feasibility and utility study Comparison group: None Exercise and education-based mHealth program to augment traditional centre-based CR effectiveness 30 day intervention period Long-term engagement: no engagement or follow-up reported beyond the 30 day intervention period. Primary outcomes: qualitative feedback and engagement with technology Statistical analysis: Data collected and structured automatically by the application and presented as reports. Qualitative data assessed through surveys. | Mean age 59 (43–76) years; 33% aged > 65 years Study completion/attrition: not reported Usability (mean): 90% daily engagement Utility: Task completion • 78% overall • 88% educational • 82% survey • 79% medication reminder • 70% physical activity (30 min) on 3 days/week Heart Coach had 42% lower visit cancellations vs no Heart Coach Staff typically spent about 20 min a day reviewing all patients’ progress and sending patient messages. (32 messages per patient over the study) Positive impact and reinforced impact of clinical-based sessions |
Varnfield, 2011 Australia | Post-MI patients eligible for CR n = 15% M/F not reported Metropolitan CR centres Rural patients not included Theoretical model: Self-management | mHealth Smartphone: • Integrated accelerometer sensor • step counter • Wellness Diary • Relaxation audio files • Educational multimedia • Weekly telephone mentoring sessions • Text messages Non-mHealth Clinical Review at CR centre (baseline and 6 weeks). Face-to-face training on CAP BP monitor and Weight scales (data entered into Wellness Diary) ‘My Heart My Life’ manual Participant and Mentor questionnaires on usability and uptake of technology and adherence. Internet web portal for viewing of patient data by mentors | Internal feasibility study: preliminary analysis of CAP data from RCT (CAP vs TCR). Comparison group: None Comprehensive delivery of core components of CR: Exercise and education-based intervention 6 week CAP CR program Long-term engagement: not reported Statistical analysis: Uptake and use determined through data uploaded daily to remote web portal. | Patients: Mean age 59 years Study completion/attrition: Internal feasibility study of 15 CAP participants Uptake, Usability and adherence: Average usage rate: Wellness Diary 91.5%; Step Counter 97%; Wellness Diary Connected internet application use was 36% due to lack of computer or internet connection; 91% reported that phone contact with mentor was motivational. Mentors: Usability and safety: CAP practical and easy to use with benefits to patients (reduced travel, return to work). Concerns over lack of exercise supervision, individual motivation levels and group support. |
Blasco, 2012 Spain | Patients with ACS and one CV risk factor (tobacco smoking, LDLc ≤100 mg/dl (2.6 mmol/L), hypertension; or diabetes mellitus) n = 203 (80% M) TMG: n = 102 (30 T2D; 81% M) CG: n = 101 (26 T2D; 79% M) Metropolitan tertiary hospital Rural patients not reported. Theoretical model: None | mHealth Nokia mobile phone with Wireless Application Protocol (WAP) technology and secure Web Portal Patient: BP, HR, weight (weekly), glucose and lipids (monthly) levels sent through mobile phone via structured questionnaire. Cardiologist: Secure Web Portal for access of results. Individualized recommendations via short text messages Non-mHealth TMG Omron automatic blood pressure monitor, CardioChek glucose and lipid meter. Patient Satisfaction Questionnaire at exit visit All Baseline and exit visit: clinical assessment, blood samples and SF-36 and State-Trait Anxiety Inventory for adults. 3 clinical visits with cardiologist | Single-blind RCT Telemonitoring Group (TMG) vs Control group (CG). All patients received lifestyle counselling and usual care 12 month follow-up Long-term engagement: no engagement or follow-up reported beyond the 12 month intervention period. Statistical analysis: Intention to treat. Independent and paired t tests; X2 test and relative risk | Mean age (years) ± SD: 60.6 ± 11.3 (TMG) vs 61.0 ± 12.1 (CG) Primary Outcome: CV Risk improvement: TMG (n = 87) 69.6% vs CG (n = 83) 50.5% P = 0.01 TMG vs CG meeting treatment goals for BP < 140/90 mmHg (62.1% vs 42.9%, p = 0.012); HbA1c < 7% (86.4% vs 54.2%, p = 0.018); smoking cessation (p = 0.964) and LDL-C (p = 0.948) Completion/attrition: 87% (n = 177) completion rate with a 13% attrition - 4 participants were lost to follow-up and 5 died (all in the CG). 17 participants left the study (12 TMG and 5 CG): Reasons were stress of telemonitoring (n = 3 TMG), personal reasons (n = 7 TMG, n = 5 CG) and inability to operate equipment (n = 2 TMG) Adherence to protocol: 98% completed > 50% of sessions; 83% completed > 75% of sessions. |
Varnfield, Nov 2014 Australia | Post-MI patients n = 94 (82 M; 12 F) CAP: n = 53 (91% M) TCR: n = 41 (83% M) Metropolitan CR centres Rural patients not included Theoretical model: Self-management | mHealth CAP-CR Patient: Smartphone • Integrated accelerometer sensor • Step counter • Wellness Diary • Relaxation audio files • Educational multimedia Community Care Team • Internet web portal for viewing of patient data • Text messages • Video and Telephone mentoring Non-mHealth All: ‘My Heart My Life’ manual CAP-CR Clinical Review at CR centre. Face-to-face training in CAP. Blood pressure monitor and Weight scales TCR program Two supervised exercise and 1 h education sessions weekly for 6 weeks at CR centre. | RCT of CAP compared with TCR. Comprehensive CR program 6 week CR intervention Long-term engagement: included a Self-management phase. CAP-CR participants kept smartphone and monitoring devices for this phase. Participants were encouraged to maintain lifestyle changes. Secondary outcomes, activity monitoring and perception of using a smartphone to monitor exercise was measured at 6 months Statistical analysis: ITT basis; Chi squared; Independent t test; Wilcoxon rank-sum test; ANCOVA adjusted for age and gender; Linear mixed model regression | Mean age (years) ± SD: 54.9 ± 9.6 (CAP) vs 56.2 ± 10.1 (TCR) Primary outcome: Uptake: 80% CAP vs 62% TCR, P < 0.05 Adherence: 94% CAP vs 68% TCR, P < 0.05 Study completion: 80% CAP vs 47% TCR completed, p < 0.05 Attrition: N = 44 dropouts, 70% from TCR (non-uptake / non-completion). Life demands: TCR - 10% Work, 4% stress; CAP – 0% Logistics: TCR - 16% Time, 7% location, 2% transport; CAP - 2% time Change in circumstances: TCR - 14% health, 2% criteria; CAP - 9% health, 7% smartphone Study design: TCR - 10%; CAP - 0% Motivation: TCR – 4%; CAP – 2% Improved health: TCR – 0%; CAP – 2% Privacy: TCR – 2%; CAP -)% Other reasons: TCR – 2%; CAP – 5% Technology: 7% (n = 3) reported difficulty with mHealth tools Secondary outcomes: CAP was as effective as TCR in improving: dietary intake; depression; 6MWT and triglycerides (p < 0.05). CAP effectively reduced psychological distress; anxiety levels; weight, WC and HRQOL (p < 0.05). TCR effectively reduced TC (P = 0.04) Between-group differences: DBP and HRQOL < 0.05 for CAP and Tgs < 0.05 for TCR Cost analysis: Based on 2010 Australian health economics data, CAP CR may result in AU$16.6 million readmission cost savings |