DCP3 Based Multi-component Intervention for Hypertension Management and Control

NCT04336631 | Completed DMC

• 1 other identifier: NCT 2224/2017
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Hypertensive Patients

Outcome Measures

Primary Outcomes (4)

• Number of participants with adequate blood pressure control in the intervention arm after delivering the intervention at 03 months

  03 months

• 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

• 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

• 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

Study Arms (2)

Routine Medical Follow Up, Counseling & Usual Care

OTHER

Behavioral counseling was provided to the patients on each consecutive follow up after enrolling in this study. They were adequately followed on physical exercise, reduced salt intake, lifestyle modifications, and smoking cessation. All measurements of blood pressure and weight were maintained and recorded.

Behavioral: Intervention on DCP3 based strategies for Hypertension Management and Control

Routine Medical Follow Up & Usual Care

NO INTERVENTION

Usual routine medical care was provided to the study participants only.

Interventions

Intervention on DCP3 based strategies for Hypertension Management and Control BEHAVIORAL

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.

Routine Medical Follow Up, Counseling & Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Health Services Academy, Islamabad, Pakistan: lead

Study Sites (1)

Armed Forces Institute of Cardiology (AFIC/NIHD)

Rawalpindi, <Select>, 74200, Pakistan

Location

Related Publications (1)

• Khan SA, Hafeez A, Zaka A, Khan SA, Ahmed A, Pervaiz F, Siddiqui AH. A Randomized Controlled Trial of Blood Pressure Reduction Based on Disease Control Priorities 3 in Pakistan to Manage and Control Hypertension. High Blood Press Cardiovasc Prev. 2023 Jul;30(4):357-366. doi: 10.1007/s40292-023-00589-y. Epub 2023 Jul 26.

  PMID: 37493898 DERIVED

Related Links

• A Study Protocol on Hypertension

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator PhD Scholar (Public Health)

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 7, 2020
• Study Start: November 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: March 30, 2020
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

PA (1)