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

NCT ID: NCT07131176

Last Updated: 2025-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2026-12-30

Brief Summary

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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

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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.

Conditions

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Hypertension Cardio Vascular Disease Educational Intervention Self Care Video Streaming

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
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.

Study Groups

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Control Arm: Standardized clinic care with Doctor Advice

In this arm, patient will receive all doctor's consultation and standardized care provided in the clinic setting.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention :" Educational Intervention through pictorial infographs"

Standardized clinic care + pictorial info-graphs distribution at every follow-up visit

Group Type EXPERIMENTAL

Behavior Change through Education intervention

Intervention Type OTHER

The I-Change Model We used behavior alteration theory to identify areas of thinking or conduct that might potentially lead to issues in the process of collecting or consuming medicine. Subsequently, we proceeded to create and improve the substance of the message, and we aligned the messages with a standardized classification of evidence-based strategies for modifying behavior.

Unclear or confusing information in infographics and television videos was revised, while information that was deemed unhelpful or insignificant by both patients and clinicians was eliminated. Patients' feedback was used to create fresh material for television videos and infographics.

1. Encourage patients about routine clinic appointments
2. Provide relevant health-related information.
3. Help participants plan and organize various treatment adherence behaviors including medication collection and taking, diet, and exercise
4. Support positive adherence-related behaviors

Intervention : "Education intervention through video of self-care in LCD"

Standardized clinic care + hypertension care enhanced Video message in the local language at the waiting area through fastening LCD of the designated cluster.

Group Type EXPERIMENTAL

Behavior Change through Education intervention

Intervention Type OTHER

The I-Change Model We used behavior alteration theory to identify areas of thinking or conduct that might potentially lead to issues in the process of collecting or consuming medicine. Subsequently, we proceeded to create and improve the substance of the message, and we aligned the messages with a standardized classification of evidence-based strategies for modifying behavior.

Unclear or confusing information in infographics and television videos was revised, while information that was deemed unhelpful or insignificant by both patients and clinicians was eliminated. Patients' feedback was used to create fresh material for television videos and infographics.

1. Encourage patients about routine clinic appointments
2. Provide relevant health-related information.
3. Help participants plan and organize various treatment adherence behaviors including medication collection and taking, diet, and exercise
4. Support positive adherence-related behaviors

Intervention: Education intervention through video of self-care in LCD + pictorial infograph

Standardized clinic care + Hypertension care enhanced pictorial infographic pamphlet distribution at every follow-up visit + hypertension care enhanced Video message at waiting area through fastened LCD of the designated cluster

Group Type EXPERIMENTAL

Behavior Change through Education intervention

Intervention Type OTHER

The I-Change Model We used behavior alteration theory to identify areas of thinking or conduct that might potentially lead to issues in the process of collecting or consuming medicine. Subsequently, we proceeded to create and improve the substance of the message, and we aligned the messages with a standardized classification of evidence-based strategies for modifying behavior.

Unclear or confusing information in infographics and television videos was revised, while information that was deemed unhelpful or insignificant by both patients and clinicians was eliminated. Patients' feedback was used to create fresh material for television videos and infographics.

1. Encourage patients about routine clinic appointments
2. Provide relevant health-related information.
3. Help participants plan and organize various treatment adherence behaviors including medication collection and taking, diet, and exercise
4. Support positive adherence-related behaviors

Interventions

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Behavior Change through Education intervention

The I-Change Model We used behavior alteration theory to identify areas of thinking or conduct that might potentially lead to issues in the process of collecting or consuming medicine. Subsequently, we proceeded to create and improve the substance of the message, and we aligned the messages with a standardized classification of evidence-based strategies for modifying behavior.

Unclear or confusing information in infographics and television videos was revised, while information that was deemed unhelpful or insignificant by both patients and clinicians was eliminated. Patients' feedback was used to create fresh material for television videos and infographics.

1. Encourage patients about routine clinic appointments
2. Provide relevant health-related information.
3. Help participants plan and organize various treatment adherence behaviors including medication collection and taking, diet, and exercise
4. Support positive adherence-related behaviors

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aga Khan University

OTHER

Sponsor Role collaborator

SINA Health Education and Welfare Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Hina Sharif, PharmD,MSPH

Role: CONTACT

03373305666

Sana S Sheikh, MSc. MPH

Role: CONTACT

Other Identifiers

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00007

Identifier Type: -

Identifier Source: org_study_id

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