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A Novel Digital Platform for a Monitored Home-based Cardiac Rehabilitation Program
Published on: April 19, 2019
Rationale, Design and Baseline Characteristics of a Randomized Controlled Trial of a Cardiovascular Quality
Kavita Singh1, Kalyani Nikhare2, Mareesha Gandral2
1Public Health Foundation of India, New Delhi, India; Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany; Centre for Chronic Disease Control, New Delhi, India.
Insights
This study tested a Collaborative Quality Improvement Program (C-QIP) for cardiovascular disease (CVD) care in India. The multicomponent strategy showed feasibility and acceptability, informing future large-scale trials in low-resource settings.
Area of Science:
- Cardiology
- Public Health
- Implementation Science
Background:
- Chronic care for cardiovascular disease (CVD) is suboptimal globally.
- The Collaborative Quality ImProvement (C-QIP) trial addresses this by testing a multicomponent strategy in India.
- The intervention was locally developed and adapted using the Consolidated Framework for Implementation Research (CFIR).
Purpose of the Study:
- To develop and test the feasibility and clinical effect of a multicomponent strategy for prevalent CVD patients in India.
- To assess implementation feasibility, fidelity, acceptability, adoption, and appropriateness of the C-QIP strategy.
- To evaluate the clinical impact on guideline-directed medical therapy (GDMT) prescription and patient-level outcomes.
Main Methods:
- A clinic-based, open randomized trial comparing C-QIP intervention with usual care.
- The C-QIP intervention included electronic health records, nonphysician health workers, text-message reminders, patient education, and audit/feedback.
- 410 patients with CVD were recruited from September 2022 to September 2023 for at least 12 months follow-up.
Main Results:
- 410 socio-demographically diverse patients with CVD were recruited from 4 Indian hospitals.
- Baseline characteristics included a mean age of 57.5 years, 73.0% males, and high prevalence of hypertension (48.5%) and diabetes (41.5%).
- Baseline GDMT prescription varied significantly by CVD type, ranging from 36.1% to 62.4%.
Conclusions:
- The C-QIP strategy is feasible and acceptable for delivering contextually relevant, evidence-based CVD care.
- Results will inform a larger-scale confirmatory trial for a comprehensive CVD care model in low-resource settings.
- The study provides a foundation for improving chronic CVD care quality in similar settings.
Background:
Quality of chronic care for cardiovascular disease (CVD) remains suboptimal worldwide. The Collaborative Quality ImProvement (C-QIP) trial aims to develop and test the feasibility and clinical effect of a multicomponent strategy among patients with prevalent CVD in India.
Methods:
The C-QIP is a clinic-based, open randomized trial of a multicomponent intervention vs usual care that was locally developed and adapted for use in Indian settings through rigorous formative research guided by Consolidated Framework for Implementation Research (CFIR). The C-QIP intervention consisted of 5 components: 1) electronic health records and decision support system for clinicians, 2) trained nonphysician health workers (NPHW), 3) text-message based lifestyle reminders, 4) patient education materials, 5) quarterly audit and feedback reports. Patients with CVD (ischemic heart disease, ischemic stroke, or heart failure) attending outpatient CVD clinics were recruited from September 2022 to September 2023 and were randomized to the intervention or usual care arm for at least 12 months follow-up. The co-primary outcomes are implementation feasibility, fidelity (ie, dose delivered and dose received), acceptability, adoption and appropriateness, measured at multiple levels: patient, provider and clinic site-level, The secondary outcomes include prescription of guideline directed medical therapy (GDMT) (provider-level), and adherence to prescribed therapy, change in mean blood pressure (BP) and LDL-cholesterol between the intervention and control groups (patient-level). In addition, a trial-based process and economic evaluations will be performed using standard guidelines.
Results:
We recruited 410 socio-demographically diverse patients with CVD from 4 hospitals in India. Mean (SD) age was 57.5 (11.7) years, and 73.0% were males. Self-reported history of hypertension (48.5%) and diabetes (41.5%) was common. At baseline, mean (SD) BP was 127.9 (18.2) /76.2 (11.6) mm Hg, mean (SD) LDLc: 80.3 (37.3) mg/dl and mean (SD) HbA1c: 6.8% (1.6%). At baseline, the GDMT varied from 62.4% for patients with ischemic heart disease, 48.6% for ischemic stroke and 36.1% for heart failure.
Conclusion:
This study will establish the feasibility of delivering contextually relevant, and evidence-based C-QIP strategy and assess whether it is acceptable to the target populations. The study results will inform a larger scale confirmatory trial of a comprehensive CVD care model in low-resource settings.
Trial Registration:
Clinical Trials Registry India: CTRI/2022/04/041847; Clinicaltrials.gov number: NCT05196659.
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