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Clinical Trials/NCT07131176
NCT07131176Not yet recruitingNot Applicable

Assessing the Feasibility of Multimedia Interventions to Reduce Blood Pressure in Marginalized Hypertensive Communities of Karachi, Pakistan

SINA Health Education and Welfare Trust0 sites150 target enrollmentStarted: December 15, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
150
Primary Endpoint
Change in Systolic and/or Diastolic Blood Pressure

Study Overview

Brief Summary

This study utilizes the I-Change Model to empower individuals in literacy-limited settings, where the majority of the population is illiterate. By leveraging multimedia tools-such as an educational video and a pictorial infographic-we aim to promote self-care practices among individuals suffering from hypertension. Through these tailored interventions, we seek to enhance awareness, improve hypertension management, and encourage behavioral change, even in low-literacy communities

Detailed Description

This study is grounded in the I-Change Model, a behavioral change framework that emphasizes awareness, motivation, and ability as key drivers for adopting healthier lifestyles. Recognizing the barriers posed by low literacy in many underserved communities, particularly in urban slums, we aim to implement context-sensitive interventions that empower individuals with hypertension to take charge of their health. In these settings, traditional written health education materials often fail to reach or resonate with the population due to widespread illiteracy and limited health literacy. To address this gap, our study introduces two key multimedia tools: an educational video, designed with simple language and culturally relevant visuals to demonstrate self-care techniques; and a pictorial infographic that visually conveys essential information about hypertension management, medication adherence, dietary habits, and physical activity. By combining these tools with physician consultations, we hope to strengthen patient understanding, increase engagement with self-care practices, and ultimately improve blood pressure control. This multimedia-based, patient-centered approach offers a scalable and cost-effective strategy for promoting behavioral change in marginalized, low-literacy populations.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Care Provider, Outcomes Assessor)

Masking Description

In the proposed intervention, masking and blinding are essential components to minimize bias and ensure the integrity of the study results. The biostatistician involved in data analysis will be blinded to group assignments, meaning they will not have knowledge of which participants received the video messaging and visual infographics intervention versus those in the control group. This approach prevents any unconscious influence on the statistical analysis, maintaining objectivity in interpreting the outcomes. Additionally, the outcome assessors, who will measure the participants' blood pressure and other health indicators, will also be masked to the group allocations. They will conduct assessments without knowledge of whether the participant is in the intervention or control group, further reducing the risk of bias in the measurement process.

Eligibility Criteria

Ages
21 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants will be hypertension patients with an active primary healthcare clinic registration from eight chosen clinics situated in Karachi, Pakistan's slums.
  • Anyone between the ages of 21 and 70 who has been diagnosed with hypertension at one of SINA's participating clinics in the last 30 days is eligible to participate.
  • Participants will be required to take medicine to control their blood pressure,
  • sign an informed consent form,
  • attend primary healthcare clinic on a regular basis, and
  • have proficiency in five local languages: Urdu, Sindhi, Balochi, Pashto, or Punjabi.

Exclusion Criteria

  • a patient's pregnancy or lactation status, a history of cancer that may necessitate medication changes,
  • a blood pressure reading greater than 220/120 mmHg,
  • a disability that prevents the patient from reading, writing, communicating, or watching television, and participation in any other study.

Outcomes

Primary Outcomes

Change in Systolic and/or Diastolic Blood Pressure

Time Frame: 3, 6, 9 months post intervention

Change in Systolic and/or Diastolic Blood Pressure from baseline to follow-up

Secondary Outcomes

  • Change in hypertension knowledge score(at 3, 6, 9 months post intervention)
  • Dietary modifications (e.g., reduced salt intake)(at 3, 6, 9 months post intervention)
  • Adherence to antihypertensive medication(at 3, 6, 9 months post intervention)
  • Number of clinic visits or follow-up consultations(3, 6, 9 months post intervention)
  • BMI management in Kg/m2(3,6,9 months post intervention)
  • Smoking control (number of cigarettes per day)(3, 6, 9 months post intervention)
  • Physical activity(3, 6, 9 months intervention)

Investigators

Sponsor
SINA Health Education and Welfare Trust
Sponsor Class
Other
Responsible Party
Sponsor

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