DCP3 Based Multi-component Intervention for Hypertension Management and Control

Hypertension Clinical Trial

Official title:

Implementation of DCP3 Strategies to Manage and Control Hypertension Among Hypertensive Patients in Pakistan: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04336631
• Other study ID #: NCT 2224/2017
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: April 2020
• Source: Health Services Academy, Islamabad, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to enable delivery of a multi-component intervention comprising of strategies based on Disease Control Priorities 3rd edition for management of hypertension among hypertensive patients. The secondary objective is to test the feasibility, acceptability and adaptability of a multi-component intervention delivered at a tertiary level health-care facility in the cultural context of Pakistan. A formative research study was conducted before so as to develop and test the intervention in a tertiary care hospital setting. The investigators employed qualitative research methods to explore the feasibility, applicability, and acceptance of DCP3 based intervention comprising of strategies for hypertension management. Focus group discussions and in-depth interviews with selected study participants were conducted at Armed Forces Institute of Cardiology (AFIC/NIHD), Rawalpindi for which a prior written and verbal consent was obtained from all research participants. The study adhered to the ethical principles of involving human subjects in the research. All information provided by the participants was recorded and was kept strictly confidential.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 30, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• • Pakistani nationals both male and female of age 18 years and above will be invited to participate in the study

• Similarly; known hypertensive patients having a systolic blood pressure of =140 mmHg on current treatment will be included &

• Patients with co-morbidities will also be included such as those suffering from cardiac ailments (angina or transient ischemic attack (TIA) and diabetes

Exclusion Criteria:

• • Patients with compromised neurological or cognitive state who are unable to provide their consent will be excluded

• Patients suffering from non-cardiovascular diseases and life-threatening illnesses such as angiographically proven coronary disease, peripheral or cerebral vascular disease, pulmonary hypertension, having history of myocardial infarction, stroke/PCI/stent or high-risk conditions will be excluded from participation

• Patients with chronic conditions and co-morbidities requiring surgical intervention or treatment such as cardiomyopathies or congenital abnormalities &

• Patients receiving dialysis will also be excluded from the study

Related Conditions & MeSH terms

• Hypertension
• Hypertensive Patients

Intervention

Behavioral:
• Intervention on DCP3 based strategies for Hypertension Management and Control
Intervention on DCP3 based strategies for Hypertension Management and Control was developed after formative research findings and evidence built on desk review which was conducted prior to implementation of the multi-componnet strategy. It was tested and implemented in a tertiary care hospital of cardiology among hypertensive patients visiting out-patient department in Rawalpindi, Pakistan.

Locations

Country	Name	City	State
Pakistan	Armed Forces Institute of Cardiology (AFIC/NIHD)	Rawalpindi	<Select>

Sponsors (1)

Lead Sponsor	Collaborator
Health Services Academy, Islamabad, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adequate blood pressure control in the intervention arm after delivering the intervention at 03 months		03 months
Primary	Number of participants with reduced salt intake from baseline measurements as compared to follow up measurements at 03 months	This was assessed at each consecutive follow up of hypertensive patients for reduced salt intake and increased physical exercise. Hypertensive patients were also counselled for regular intake of medicines prescribed by the physician. A record for the mentioned measurements was kept and maintained from baseline to 03 months of the trial.	Baseline to follow up in 03 months
Primary	Number of participants with increased level of physical exercise compared from baseline measurements to follow up measurements at 03 months	This was assessed at each consecutive follow up of hypertensive patients for reduced salt intake and increased physical exercise. Hypertensive patients were also counselled for regular intake of medicines prescribed by the physician. A record for the mentioned measurements was kept and maintained from baseline to 03 months of the trial.	03 months
Primary	Number of participants with regular compliance to medications from baseline measurement compared with follow up measurements at 03 months	This was assessed at each consecutive follow up of hypertensive patients for reduced salt intake and increased physical exercise. Hypertensive patients were also counselled for regular intake of medicines prescribed by the physician. A record for the mentioned measurements was kept and maintained from baseline to 03 months of the trial.	03 months

External Links

•   A Study Protocol on Hypertension