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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
  1. Key: n/a not applicable, CR Cardiac Rehabilitation, NS No Significant Change, RCT Randomised Controlled Trial, MI Myocardial Infarction, CAP Care Assessment Platform, TCR Traditional Cardiac Rehabilitation, T2D Type 2 Diabetes, 6MWT 6 Minute Walk Test, WC Waist Circumference, DPB Diastolic Blood Pressure, EQ5D-Index A Health-related Quality of Life Index, Tgs Triglycerides, TC Total Cholesterol, ACS Acute Coronary Syndrome, CV Cardiovascular, TMG Telemonitoring Group, IG Intervention Group, CG Control Group, BP Blood Pressure, BMI Body Mass Index, LDL-C Low-density Lipoprotein Cholesterol, HbA1 c Glycated Haemoglobin A1c, SF-36 Health Related Quality of Life Short Form 36, QOL Quality of Life, HC Heart Coach application, PVO 2 peak oxygen uptake, wk. week, ANCOVA Analysis of Covariance, NZ New Zealand; ns no significant difference, SD Standard Deviation
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