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:

  1. 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.
  2. To assess the transferability of components of internationally successful multifaceted quality improvement strategies and chronic care models to the Indian healthcare context.
  3. 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.
  4. 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

  • India
    • Karnataka
      • Dharwad, Karnataka, India, 580009
        • SDM College of Medical Sciences and Hospital
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110 029
        • All India Institute Of Medical Sciences (AIIMS)
    • New Delhi
      • New Delhi, New Delhi, India, 110002
        • GB Pant Hospital
      • New Delhi, New Delhi, India, 110060
        • Sir Ganga Ram Hospital

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
  • Regular current system of care
  • Treating physicians provided current cardiovascular disease management guidelines
  • Patients provided a leaflet (printed information) on healthy lifestyle
Active Comparator: INTERVENTION Group

  1. Electronic Health Record-Decision Support Software (EHR-DSS):

    • Electronic patient health record storage
    • Management prompts to the clinical team (following algorithms)
    • Structured follow-up schedule with automatic reminders to patients, clinical team, and non-physician health worker

  2. Non-physician health worker-led continuity of care:

    - individually tailored follow-up and guidance regarding treatment adherence as well as help in resolving issues related to access, convenience, cost of care, and equity

  3. Text-message based reminders for a healthy lifestyle
  4. Patient diary containing visual assessment tool for adherence to medication (VITA) and reinforcement tool for lifestyle modification
  5. Quarterly audit and feedback to the clinical team
Behavioral: Integrated comprehensive cardiovascular disease management

  1. Electronic Health Record-Decision Support Software (EHR-DSS):

    • Electronic patient health record storage
    • Management prompts to the clinical team (following algorithms)
    • Structured follow-up schedule with automatic reminders to patients, clinical team, and non-physician health worker

  2. Non-physician health worker-led continuity of care:

    - individually tailored follow-up and guidance regarding treatment adherence as well as help in resolving issues related to access, convenience, cost of care, and equity

  3. Text-message based reminders for a healthy lifestyle
  4. Patient diary containing visual assessment tool for adherence to medication (VITA) and reinforcement tool for lifestyle modification
  5. Quarterly audit and feedback to the clinical team

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.
at the end of study (maximum follow-up duration 24 months).
Prescription of evidence based medicines
Time Frame: at the end of study (maximum follow-up duration 24 months).
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
Time Frame: at the end of study (maximum follow-up duration 24 months).
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).

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.
at the end of study (maximum follow-up duration 24 months).
Change in low density lipoprotein cholesterol (LDLc)
Time Frame: at the end of study (maximum follow-up duration 24 months).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Health Foundation of India

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.

General Publications

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.

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