Coronary Heart DiseaseC-QIPNCT05196659
Collaborative Quality Improvement (C-QIP) Study
A study testing Integrated comprehensive cardiovascular disease management in people with Coronary Heart Disease and Ischemic Stroke, run by Public Health Foundation of India at 4 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Ischemic Stroke, Heart Failure
- What is being tested?
- Integrated comprehensive cardiovascular disease management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 4 sitesIndia
- Study dates
- 9 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- pregnant women
- those with any serious or uncontrolled medical condition (e.g., cancer) that may restrict the patient to come for follow-up.
Trial locations and contacts
4 sites in 1 country.
India4 sites
SDM College of Medical Sciences and Hospital
Dharwad, Karnataka, 580009
All India Institute of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, 110 029
GB Pant Hospital
New Delhi, New Delhi, 110002
Sir Ganga ram Hospital
New Delhi, New Delhi, 110060
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Heart Disease, Ischemic Stroke, Heart Failure
- Being tested
- Integrated comprehensive cardiovascular disease management
- Medical subject headings
- Coronary Disease, Ischemic Stroke, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated comprehensive cardiovascular disease managementBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Integrated comprehensive cardiovascular disease management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: at the end of study (maximum follow-up duration 24 months).
Secondary outcomes (2)
Change in blood pressure
Mean change in systolic and diastolic blood pressure between the intervention and control group participants at the trial end.
Measured: at the end of study (maximum follow-up duration 24 months).
Change in low density lipoprotein cholesterol (LDLc)
Mean change in LDLc between the intervention and control group participants at the trial end.
Measured: at the end of study (maximum follow-up duration 24 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start9 Sep 2022
- Primary completion30 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individual randomized parallel-group feasibility trial
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation of India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kavita Singh, PhD, Principal investigator, Public Health Foundation of India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196659
- Sponsor's protocol ID
- RA1055
- Acronym
- C-QIP
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2021
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be made available to other researchers upon reasonable request to the study PI.
Publications
Singh K, Roy A, Kondal D, Nikhare K, Gandral M, Patil SG, Aithal K, Girish MP, Gupta M, Madan K, Sawhney JPS, Ali K, Jain M, Kushwaha S, Jindal D, Mendenhall E, Patel SA, Narayan KMV, Tandon N, Huffman MD, Prabhakaran D. Assessing a multicomponent quality improvement strategy for chronic care of cardiovascular diseases in India: The C-QIP randomized feasibility trial. PLoS Med. 2026 Sep 29;23(9):e1004932. doi: 10.1371/journal.pmed.1004932. Online ahead of print.
PubMed 42809588Singh 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.
PubMed 41646739Singh 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.
PubMed 39033994
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Testing a Collaborative Quality ImProvement (C-QIP) Initiative for Prevention of Cardiovascular Disease in India
- ClinicalTrials.gov ID
- NCT05196659
- Acronym / sponsor ID
- C-QIP / RA1055
- Conditions
- Coronary Heart Disease, Ischemic Stroke, Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Public Health Foundation of IndiaUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individual randomized parallel-group feasibility trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Integrated comprehensive cardiovascular disease management1. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- pregnant women
- those with any serious or uncontrolled medical condition (e.g., cancer) that may restrict the patient to come for follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated comprehensive cardiovascular disease management1. 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 | Behavioural | INTERVENTION Group |
Primary outcome
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.
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.
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.
2 secondary outcomes
Change in blood pressure
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Derived from this study: PubMed 42809588Singh K, Roy A, Kondal D, Nikhare K, Gandral M, Patil SG, Aithal K, Girish MP, Gupta M, Madan K, Sawhney JPS, Ali K, Jain M, Kushwaha S, Jindal D, Mendenhall E, Patel SA, Narayan KMV, Tandon N, Huffman MD, Prabhakaran D. Assessing a multicomponent quality improvement strategy for chronic care of cardiovascular diseases in India: The C-QIP randomized feasibility trial. PLoS Med. 2026 Sep 29;23(9):e1004932. doi: 10.1371/journal.pmed.1004932. Online ahead of print.
- Derived from this study: PubMed 41646739Singh 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.
- Derived from this study: PubMed 39033994Singh 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.
- Individual participant dataSharing planned: Yes. Individual participant data will be made available to other researchers upon reasonable request to the study PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kavita Singh, PhD principal investigator
Public Health Foundation of India
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated comprehensive cardiovascular disease management in people with Coronary Heart Disease and Ischemic Stroke, run by Public Health Foundation of India at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implementation outcomes (time frame: at the end of study (maximum follow-up duration 24 months).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05196659, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.