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Not yet recruitingNCT07131176Updated Aug 20, 2025

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

An interventional study of Behavior Change through Education intervention in Hypertension, Cardio Vascular Disease and Educational Intervention, sponsored by SINA Health Education and Welfare Trust. Not yet recruiting. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-20.

Sponsored by SINA Health Education and Welfare Trust · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

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

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Keywords

  • high blood pressure
  • self-care
  • hypertension
  • I-changed model
  • marginalized population
  • educational intervention
03

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • No intervention
    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.

  • Experimental
    Intervention :" Educational Intervention through pictorial infographs"

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

    Other: Behavior Change through Education intervention

  • Experimental
    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.

    Other: Behavior Change through Education intervention

  • Experimental
    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

    Other: Behavior Change through Education intervention

Interventions

  • OtherBehavior 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

05

What researchers measure

Primary outcomes

  1. Change in Systolic and/or Diastolic Blood Pressure

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

    Time frame: 3, 6, 9 months post intervention

Secondary outcomes

  1. Change in hypertension knowledge score

    From baseline to post intervention, knowledge about self-care among interventional arms

    Time frame: at 3, 6, 9 months post intervention

  2. Adherence to antihypertensive medication

    The Hill bone-scale, comprising 14 items, assesses medication self-efficacy in managing Hypertension (chronic diseases) and appears suitable for individuals with limited literacy skills

    Time frame: at 3, 6, 9 months post intervention

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

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

    Time frame: at 3, 6, 9 months post intervention

  4. Number of clinic visits or follow-up consultations

    Number of clinic visits or follow-up consultations

    Time frame: 3, 6, 9 months post intervention

  5. BMI management in Kg/m2

    weight control according to height in kg/m2

    Time frame: 3,6,9 months post intervention

  6. Smoking control (number of cigarettes per day)

    Smoking control starting from reduction in number of cigarettes per day to complete cessation

    Time frame: 3, 6, 9 months post intervention

  7. Physical activity

    time in minutes which shows physically active in a day (in term of walking, yoga, exercise)

    Time frame: 3, 6, 9 months intervention

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No — There is confidently matter and Organization will not allow to share

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07131176
Lead sponsor
SINA Health Education and Welfare Trust
Collaborators
Aga Khan University
Responsible party
Sponsor
First posted
Aug 20, 2025
Start date
Dec 15, 2025 (estimated)
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Aug 20, 2025

Study contacts

Hina Sharif, PharmD,MSPH
Contact
hina.shf19@gmail.com
03373305666
Sana S Sheikh, MSc. MPH
Contact
sanshf4@gmail.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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