Collaborative Quality Improvement (C-QIP) Study

NCT05196659 | Completed DMC

• 1 other identifier: RA1055
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Coronary Heart Disease; Ischemic Stroke; Heart Failure

Outcome Measures

Primary Outcomes (3)

• 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).

Secondary Outcomes (2)

• Change in blood pressure

  at the end of study (maximum follow-up duration 24 months).

• Change in low density lipoprotein cholesterol (LDLc)

  at the end of study (maximum follow-up duration 24 months).

Study Arms (2)

CONTROL Group

NO INTERVENTION

* Regular current system of care * Treating physicians provided current cardiovascular disease management guidelines * Patients provided a leaflet (printed information) on healthy lifestyle

INTERVENTION Group

ACTIVE COMPARATOR

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

Interventions

Integrated comprehensive cardiovascular disease management BEHAVIORAL

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

INTERVENTION Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• pregnant women
• those with any serious or uncontrolled medical condition (e.g., cancer) that may restrict the patient to come for follow-up.

Sponsors & Collaborators

• Public Health Foundation of India: lead

Study Sites (4)

SDM College of Medical Sciences and Hospital

Dharwad, Karnataka, 580009, India

Location

All India Institute of Medical Sciences (AIIMS)

New Delhi, National Capital Territory of Delhi, 110 029, India

Location

GB Pant Hospital

New Delhi, New Delhi, 110002, India

Location

Sir Ganga ram Hospital

New Delhi, New Delhi, 110060, India

Location

Related Publications (2)

• 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.

  PMID: 41646739 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.

  PMID: 39033994 DERIVED

MeSH Terms

Conditions

Coronary Disease; Ischemic Stroke; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kavita Singh, PhD

  Public Health Foundation of India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individual randomized parallel-group feasibility trial

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 19, 2022
• Study Start: September 9, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will be made available to other researchers after completion of the study and publication of primary results (Dec 2025).

Locations

IN (4)