Clinical trial NCT04336631: DCP3 Based Multi-component Intervention for Hypertension Management and Control
Official title: Implementation of DCP3 Strategies to Manage and Control Hypertension Among Hypertensive Patients in Pakistan: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Hypertensive Patients
Lead sponsor: Health Services Academy, Islamabad, Pakistan
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adequate blood pressure control in the intervention arm after delivering the intervention at 03 months
timeFrame: 03 months
measure: Number of participants with reduced salt intake from baseline measurements as compared to follow up measurements at 03 months
timeFrame: Baseline to follow up in 03 months
measure: Number of participants with increased level of physical exercise compared from baseline measurements to follow up measurements at 03 months
timeFrame: 03 months
measure: Number of participants with regular compliance to medications from baseline measurement compared with follow up measurements at 03 months
timeFrame: 03 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute of Cardiology (AFIC/NIHD)
state: <Select>
Study officials:
References: