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Completed

NCT Number: NCT05196659

Collaborative Quality Improvement (C-QIP) Study

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.

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Key information

Conditions

Coronary Heart Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Disease Heart Diseases Heart Failure Ischemic Stroke Myocardial Ischemia Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Integrated comprehensive cardiovascular disease management

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Public Health Foundation of India

Other

Registry information

Official study title

Developing and Testing a Collaborative Quality ImProvement (C-QIP) Initiative for Prevention of Cardiovascular Disease in India

Acronym: C-QIP

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2022
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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