| CTRI Number |
CTRI/2022/04/041847 [Registered on: 13/04/2022] Trial Registered Prospectively |
| Last Modified On: |
03/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Developing and testing a multicomponent care model for heart disease in India |
|
Scientific Title of Study
|
Developing and testing Collaborative Quality ImProvement initiative (C-QIP) for prevention of cardiovascular disease in India |
| Trial Acronym |
C-QIP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kavita Singh |
| Designation |
Senior Research Scientist |
| Affiliation |
Public Health Foundation of India (PHFI) |
| Address |
Public Health Foundation of India (PHFI)
Plot No 47, Sector 44, Institutional Area
Gurgaon
Gurgaon
HARYANA
122002
India |
| Phone |
|
| Fax |
|
| Email |
kavita.singh@phfi.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavita Singh |
| Designation |
Senior Research Scientist |
| Affiliation |
Public Health Foundation of India (PHFI) |
| Address |
Public Health Foundation of India (PHFI)
Plot No 47, Sector 44, Institutional Area
Gurgaon
Gurgaon
HARYANA
122002
India |
| Phone |
|
| Fax |
|
| Email |
kavita.singh@phfi.org |
|
Details of Contact Person
Public Query
|
| Name |
Kavita Singh |
| Designation |
Senior Research Scientist |
| Affiliation |
Public Health Foundation of India (PHFI) |
| Address |
Public Health Foundation of India (PHFI)
Plot No 47, Sector 44, Institutional Area
Gurgaon
Gurgaon
HARYANA
122002
India |
| Phone |
|
| Fax |
|
| Email |
kavita.singh@phfi.org |
|
|
Source of Monetary or Material Support
|
| Fogarty International Centre, National Institutes of Health, USA |
|
|
Primary Sponsor
|
| Name |
Public Health Foundation of India |
| Address |
Plot number 47, Sector 44
Gurgaon, Haryana, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ambuj Roy |
All India Institute of Medical Sciences (AIIMS) |
Room no, 32, 7th floor, Department of Cardiology, Cardio Thoracic Center, AIIMS, Ansari Nagar, New Delhi-110029.
New Delhi
DELHI |
9810992822
drambujroy@gmail.com |
| Dr Girish MP |
GB Pant Hospital |
Academic block, 1st floor, Cardiology Department, GB Pant Institute Of Post Graduate Medical Education and Research,
New Delhi-110002
New Delhi
DELHI |
9611099226
mpgirish_1999@yahoo.com |
| Dr Satish G Patil |
SDM College of Medical Sciences and Hospital |
Department of Medicine,
SDM College of Medical Sciences and Hospital,
Sattur, Dharwad, Karnataka-580009
Dharwad
KARNATAKA |
9986789583
sathupatil@yahoo.co.in |
| Dr JPS Sawhney |
Sir Ganga ram Hospital |
Department of Cardiology, Sir Ganga ram Hospital,
Sarhadi Gandhi Marg, Old Rajinder Nagar, Rajinder Nagar,
New Delhi
New Delhi
DELHI |
9810059773
jpssawhney@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| AIIMS, New Delhi |
Approved |
| AIIMS, New Delhi |
Approved |
| G.B. Pant Hospital, New Delhi |
Approved |
| G.B. Pant Hospital, New Delhi |
Approved |
| ICMR (HMSC) India |
Approved |
| Public Health Foundation of India |
Approved |
| Public Health Foundation of India |
Approved |
| Public Health Foundation of India |
Approved |
| SDM, Karnataka |
Approved |
| SDM, Karnataka |
Approved |
| Sir Ganga Ram Hospital, New Delhi |
Approved |
| Sir Ganga Ram Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Comprehensive CVD Management (Intervention Arm) |
1) Electronic Health Record-Decision Support Software (EHR-DSS) −Electronic patient health record storage −Management prompts to 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 (Quarterly for 12 months)
3) Text-message based reminders for healthy lifestyle (2-3 times a week for 12 months).
4) Patient diary containing visual assessment tool for adherence to medication (VITA) and reinforcement tool for lifestyle modification
5) Quarterly audit and feed-back to clinical team
The study duration is 24 months.
|
| Comparator Agent |
Usual Care (Usual Care arm) |
1) Treating physicians provided current cardiovascular disease management guidelines
2) Patients provided a leaflet (printed information) on healthy lifestyle
The study duration is 24 months.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: ≥18 years, both sex
2.Having physician diagnosis of or on treatment for cardiovascular disease including ischemic heart disease, ischemic stroke, or heart failure regardless of ejection fraction
3.Living within same city/town
4.Consent to participate. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women
2.Patients having diseases associated with frequent hospitalization (advanced cancer, end stage renal disease); bedridden or debilitating conditions and life expectancy <12 months that might limit completion of study follow-up
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Acceptibilty
2. Adoption
3. Appropriateness
4. Cost
5. Feasibilty
6. Fidelity |
maximum: 24 months, average: 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prescription rate of guideline directed medical therapy (GDMT) by providers
Patients adherence rate to GDMT |
maximum: 24 months, average: 18 months |
Other Pre-specified Outcome Measure:
Between group differences in:
1. Mean changes in blood pressure at trial end
2. Mean changes in LDL cholesterol at
trial end
3. Mean change in health-related quality of life
4. Incremental cost of care
5. Adherence to recommended lifestyle habits: smoking cessation, diet, physical activity, and mental health |
maximum: 24 months, average: 18 months |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "410"
Final Enrollment numbers achieved (India)="410" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2022 |
| Date of Study Completion (India) |
21/09/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kavita.singh@phfi.org].
- For how long will this data be available start date provided 01-12-2025 and end date provided 30-12-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
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 prevalent CVD in India using the United Kingdom’s Medical Research Council (MRC) framework for developing and evaluating complex interventions. Aim 1: To describe current practices, context, challenges, and opportunities regarding chronic management of CVDs (e.g. ischemic heart disease, stroke, and heart failure) from the patient, carer, provider, and health administrator perspectives in India. Aim 2 - To assess the transferability of components of internationally successful multifaceted quality improvement strategies and chronic care models to the Indian healthcare context. Aim 3: To conduct a pilot study to assess the acceptability, feasibility, and implementation fidelity of C-QIP intervention among individuals with CVD attending out-patient CVD clinics in India. Aim 4: Among individuals with CVD, evaluate the effect of C-QIP intervention on processes of care and clinical outcomes, health-related quality of life, and costs at 1 year compared with usual care. |