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The overarching goal of this study is to develop, implement, and evaluate the effect of a collaborative quality improvement (C-QIP) intervention (consisting of non-physician health workers, text messages for a healthy lifestyle, and a clinical decision support system) on processes of care and clinical outcomes among individuals with previous cardiovascular disease in India.
Specific objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CONTROL Group | No Intervention |
| |
| INTERVENTION Group | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated comprehensive cardiovascular disease management | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Implementation outcomes | Using mixed methods evaluation involving quantitative survey and in-depth interviews with the providers and patients, the primary outcome of this study is to assess the implementation outcomes such as the feasibility, and acceptability of the trial intervention defined as the extent to which providers and patients perceive the intervention strategy to be feasible to implement and useful/acceptable in their local health care setting. | at the end of study (maximum follow-up duration 24 months). |
| Prescription of evidence based medicines | Through patient chart review, the study will assess the proportion of intervention arm versus control group participant's receiving evidence based medicines for cardiovascular disease management. | at the end of study (maximum follow-up duration 24 months). |
| Adherence to prescribed therapy | Using validated questionnaire for medication adherence, the study will assess patient's compliance or adherence to prescribed therapy in the intervention group versus control group participants at the trial end. | at the end of study (maximum follow-up duration 24 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure | Mean change in systolic and diastolic blood pressure between the intervention and control group participants at the trial end. | at the end of study (maximum follow-up duration 24 months). |
| Change in low density lipoprotein cholesterol (LDLc) |
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Inclusion Criteria:
Participants should be:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kavita Singh, PhD | Public Health Foundation of India | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SDM College of Medical Sciences and Hospital | Dharwad | Karnataka | 580009 | India | ||
| All India Institute of Medical Sciences (AIIMS) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41646739 | Derived | Singh K, Roy A, Kondal D, Nikhare K, Gandral M, Patil SG, Aithal K, Mp G, Gupta M, Madan K, Sawhney J, Ali K, Jain M, Kushwaha S, Jindal D, Mendenhall E, Patel SA, Narayan KV, Tandon N, Huffman MD, Prabhakaran D. A Randomized Feasibility Trial of a Multicomponent Quality Improvement Strategy for Chronic Care of Cardiovascular Diseases: Findings from the C-QIP Trial in India. medRxiv [Preprint]. 2026 Jan 30:2026.01.28.26345028. doi: 10.64898/2026.01.28.26345028. | |
| 39033994 |
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Individual participant data will be made available to other researchers upon reasonable request to the study PI.
Data will be made available to other researchers after completion of the study and publication of primary results (Dec 2025).
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D000083242 | Ischemic Stroke |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Individual randomized parallel-group feasibility trial
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|
Mean change in LDLc between the intervention and control group participants at the trial end. |
| at the end of study (maximum follow-up duration 24 months). |
| New Delhi |
| National Capital Territory of Delhi |
| 110 029 |
| India |
| GB Pant Hospital | New Delhi | New Delhi | 110002 | India |
| Sir Ganga ram Hospital | New Delhi | New Delhi | 110060 | India |
| Derived |
| Singh K, Nikhare K, Gandral M, Aithal K, Patil SG, Mp G, Gupta M, Madan K, Sawhney JPS, Ali K, Kondal D, Jindal D, Mendenhall E, Patel SA, Narayan KMV, Tandon N, Roy A, Huffman MD, Prabhakaran D. Rationale, Design and Baseline Characteristics of a Randomized Controlled Trial of a Cardiovascular Quality Improvement Strategy in India: The C-QIP Trial. Am Heart J. 2024 Oct;276:83-98. doi: 10.1016/j.ahj.2024.07.008. Epub 2024 Jul 20. |
| D020521 |
| Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |