DCP3 Based Multi-component Intervention for Hypertension Management and Control

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Hypertensive Patients
• Intervention / Treatment: Behavioral: Intervention on DCP3 based strategies for Hypertension Management and Control

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • <Select>
    • Rawalpindi, <Select>, Pakistan, 74200
      • Armed Forces Institute of Cardiology (AFIC/NIHD)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Routine Medical Follow Up, Counseling & Usual Care; 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; 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.
NO_INTERVENTION: Routine Medical Follow Up & Usual Care; Usual routine medical care was provided to the study participants only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Health Services Academy, Islamabad, Pakistan

Publications and helpful links

Helpful Links

• A Study Protocol on Hypertension

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2019
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): March 30, 2020

Study Registration Dates

• First Submitted: April 1, 2020
• First Submitted That Met QC Criteria: April 4, 2020
• First Posted (ACTUAL): April 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 8, 2020
• Last Update Submitted That Met QC Criteria: April 6, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: NCT 2224/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No