DCP3 Based Multi-component Intervention for Hypertension Management and Control

Health Services Academy, Islamabad, Pakistan

Status: Completed

Conditions: Hypertension; Hypertensive Patients

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04336631

NCT 2224/2017

Details and patient eligibility

About

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.

Enrollment: 500 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Routine Medical Follow Up, Counseling & Usual Care

Other group

Description:

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.

Treatment:

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

Routine Medical Follow Up & Usual Care

No Intervention group

Description:

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