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

NCT07131176 | Not Yet Recruiting

• 1 other identifier: 00007
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hypertension; Cardio Vascular Disease; Educational Intervention; Self Care; Video Streaming

Keywords

high blood pressure; self-care; hypertension; I-changed model; marginalized population; educational intervention

Outcome Measures

Primary Outcomes (1)

• Change in Systolic and/or Diastolic Blood Pressure

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

  3, 6, 9 months post intervention

Secondary Outcomes (7)

• Change in hypertension knowledge score

  at 3, 6, 9 months post intervention

• Adherence to antihypertensive medication

  at 3, 6, 9 months post intervention

• Dietary modifications (e.g., reduced salt intake)

  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

Study Arms (4)

Control Arm: Standardized clinic care with Doctor Advice

NO INTERVENTION

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

Intervention :" Educational Intervention through pictorial infographs"

EXPERIMENTAL

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

Other: Behavior Change through Education intervention

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

EXPERIMENTAL

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

Other: Behavior Change through Education intervention

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

EXPERIMENTAL

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

Other: Behavior Change through Education intervention

Interventions

Behavior Change through Education intervention 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"; Intervention :" Educational Intervention through pictorial infographs"; Intervention: Education intervention through video of self-care in LCD + pictorial infograph

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SINA Health Education and Welfare Trust: lead
• Aga Khan University: collaborator

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hina Sharif, PharmD,MSPH

CONTACT

03373305666; hina.shf19@gmail.com

Sana S Sheikh, MSc. MPH

CONTACT

sanshf4@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 20, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share