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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05196659
Other study ID # RA1055
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 9, 2022
Est. completion date December 2024

Study information

Verified date August 2022
Source Public Health Foundation of India
Contact Kavita Singh, PhD
Phone 911244781400
Email kavita.singh@phfi.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 individuals with previous cardiovascular disease in India.


Description:

Specific objectives of this study are: 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
Integrated comprehensive cardiovascular disease management
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

Locations

Country Name City State
India SDM College of Medical Sciences and Hospital Dharwad Karnataka
India All India Institute of Medical Sciences (AIIMS) New Delhi Delhi
India GB Pant Hospital New Delhi
India Sir Ganga ram Hospital New Delhi

Sponsors (1)

Lead Sponsor Collaborator
Public Health Foundation of India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
Primary 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).
Primary 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 Change in blood pressure Mean change in systolic and diastolic blood pressure between the intervention and control group participants at the trial end. at the end of study (maximum follow-up duration 24 months).
Secondary Change in low density lipoprotein cholesterol (LDLc) Mean change in LDLc between the intervention and control group participants at the trial end. at the end of study (maximum follow-up duration 24 months).
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