Collaborative Quality Improvement (C-QIP) Study (C-QIP)
January 19, 2026 updated by: Public Health Foundation of India
Developing and Testing a Collaborative Quality ImProvement (C-QIP) Initiative for Prevention of Cardiovascular Disease in India
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Specific objectives of this study are:
- To describe current practices, context, challenges, and opportunities regarding chronic management of cardiovascular disease from the patient, caregiver, provider, and health administrator perspectives in India.
- To assess the transferability of components of internationally successful multifaceted quality improvement strategies and chronic care models to the Indian healthcare context.
- To conduct a pilot study to assess the acceptability, feasibility, and implementation fidelity of the C-QIP strategy among individuals with cardiovascular disease attending out-patient clinics in India.
- Among individuals with cardiovascular disease, evaluate the effect of C-QIP strategy on processes of care and clinical outcomes, health-related quality of life, and costs at 1 year compared with usual care.
Study Type
Interventional
Enrollment (Actual)
410
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Karnataka
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Dharwad, Karnataka, India, 580009
- SDM College of Medical Sciences and Hospital
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110 029
- All India Institute of Medical Sciences (AIIMS)
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New Delhi
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New Delhi, New Delhi, India, 110002
- GB Pant Hospital
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New Delhi, New Delhi, India, 110060
- Sir Ganga Ram Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Participants should be:
- age ≥18 years, both sexes
- confirmed diagnosis of cardiovascular disease (ischemic heart disease, stroke, or heart failure irrespective of ejection fraction)
- able to provide written informed consent.
Exclusion Criteria:
- pregnant women
- those with any serious or uncontrolled medical condition (e.g., cancer) that may restrict the patient to come for follow-up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: CONTROL Group
|
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Active Comparator: INTERVENTION Group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implementation outcomes
Time Frame: at the end of study (maximum follow-up duration 24 months).
|
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.
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at the end of study (maximum follow-up duration 24 months).
|
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Prescription of evidence based medicines
Time Frame: at the end of study (maximum follow-up duration 24 months).
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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.
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at the end of study (maximum follow-up duration 24 months).
|
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Adherence to prescribed therapy
Time Frame: at the end of study (maximum follow-up duration 24 months).
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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.
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at the end of study (maximum follow-up duration 24 months).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in blood pressure
Time Frame: at the end of study (maximum follow-up duration 24 months).
|
Mean change in systolic and diastolic blood pressure between the intervention and control group participants at the trial end.
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at the end of study (maximum follow-up duration 24 months).
|
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Change in low density lipoprotein cholesterol (LDLc)
Time Frame: at the end of study (maximum follow-up duration 24 months).
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Mean change in LDLc between the intervention and control group participants at the trial end.
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at the end of study (maximum follow-up duration 24 months).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kavita Singh, PhD, Public Health Foundation of India
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2022
Primary Completion (Actual)
November 30, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
December 2, 2021
First Submitted That Met QC Criteria
January 4, 2022
First Posted (Actual)
January 19, 2022
Study Record Updates
Last Update Posted (Actual)
January 21, 2026
Last Update Submitted That Met QC Criteria
January 19, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RA1055
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data will be made available to other researchers upon reasonable request to the study PI.
IPD Sharing Time Frame
Data will be made available to other researchers after completion of the study and publication of primary results (Dec 2025).
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.