Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
410 participants
INTERVENTIONAL
2022-09-09
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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CONTROL Group
* Regular current system of care
* Treating physicians provided current cardiovascular disease management guidelines
* Patients provided a leaflet (printed information) on healthy lifestyle
No interventions assigned to this group
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* those with any serious or uncontrolled medical condition (e.g., cancer) that may restrict the patient to come for follow-up.
18 Years
ALL
No
Sponsors
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Public Health Foundation of India
OTHER
Responsible Party
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Principal Investigators
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Kavita Singh, PhD
Role: PRINCIPAL_INVESTIGATOR
Public Health Foundation of India
Locations
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SDM College of Medical Sciences and Hospital
Dharwad, Karnataka, India
All India Institute of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, India
GB Pant Hospital
New Delhi, New Delhi, India
Sir Ganga ram Hospital
New Delhi, New Delhi, India
Countries
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References
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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.
Other Identifiers
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RA1055
Identifier Type: -
Identifier Source: org_study_id
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