HypertensionNCT07131176
Assessing the Feasibility of Multimedia Interventions to Reduce Blood Pressure in Marginalized Hypertensive Communities of Karachi, Pakistan
A study testing Behavior Change through Education intervention in people with Hypertension and Cardio Vascular Disease, run by SINA Health Education and Welfare Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Hypertension, Cardio Vascular Disease, Educational Intervention
- What is being tested?
- Behavior Change through Education intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sana S Sheikh, MSc. MPH contact
About this study
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.
- Conditions
- Hypertension, Cardio Vascular Disease, Educational Intervention, Self Care, Video Streaming
- Being tested
- Behavior Change through Education intervention
- Keywords
- high blood pressure, self-care, hypertension, I-changed model, marginalized population, educational intervention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior Change through Education interventionOther
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.
- Encourage patients about routine clinic appointments
- Provide relevant health-related information.
- Help participants plan and organize various treatment adherence behaviors including medication collection and taking, diet, and exercise
- Support positive adherence-related behaviors
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: Other: Behavior Change through Education intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic and/or Diastolic Blood Pressure
Change in Systolic and/or Diastolic Blood Pressure from baseline to follow-up
Measured: 3, 6, 9 months post intervention
Secondary outcomes (7)
Change in hypertension knowledge score
From baseline to post intervention, knowledge about self-care among interventional arms
Measured: at 3, 6, 9 months post intervention
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
Measured: at 3, 6, 9 months post intervention
Dietary modifications (e.g., reduced salt intake)
Dietary modifications (e.g., reduced salt intake)
Measured: at 3, 6, 9 months post intervention
Number of clinic visits or follow-up consultations
Number of clinic visits or follow-up consultations
Measured: 3, 6, 9 months post intervention
BMI management in Kg/m2
weight control according to height in kg/m2
Measured: 3,6,9 months post intervention
Smoking control (number of cigarettes per day)
Smoking control starting from reduction in number of cigarettes per day to complete cessation
Measured: 3, 6, 9 months post intervention
Physical activity
time in minutes which shows physically active in a day (in term of walking, yoga, exercise)
Measured: 3, 6, 9 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SINA Health Education and Welfare Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131176
- Sponsor's protocol ID
- 00007
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is confidently matter and Organization will not allow to share
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Multimedia Interventions to Reduce Blood Pressure in Marginalized Hypertensive Communities of Karachi, Pakistan
- ClinicalTrials.gov ID
- NCT07131176
- Acronym / sponsor ID
- 00007
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- SINA Health Education and Welfare TrustUniversity, hospital or other
- Collaborators
- Aga Khan University
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Behavior Change through Education interventionStandardized clinic care + pictorial info-graphs distribution at every follow-up visit |
| Intervention : "Education intervention through video of self-care in LCD" | Experimental | Other: Behavior Change through Education interventionStandardized clinic care + hypertension care enhanced Video message in the local language at the waiting area through fastening LCD of the designated cluster. |
| Intervention: Education intervention through video of self-care in LCD + pictorial infograph | Experimental | Other: Behavior Change through Education interventionStandardized 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 |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavior Change through Education interventionThe 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 | Other | 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 |
Primary outcome
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
7 secondary outcomes
Change in hypertension knowledge score
Time frame: at 3, 6, 9 months post intervention
Adherence to antihypertensive medication
Time frame: at 3, 6, 9 months post intervention
Dietary modifications (e.g., reduced salt intake)
Time frame: at 3, 6, 9 months post intervention
Number of clinic visits or follow-up consultations
Time frame: 3, 6, 9 months post intervention
BMI management in Kg/m2
Time frame: 3,6,9 months post intervention
Smoking control (number of cigarettes per day)
Time frame: 3, 6, 9 months post intervention
Physical activity
Time frame: 3, 6, 9 months intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No. There is confidently matter and Organization will not allow to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sana S Sheikh, MSc. MPH contact
Questions about this trial
What is this clinical trial studying?
A study testing Behavior Change through Education intervention in people with Hypertension and Cardio Vascular Disease, run by SINA Health Education and Welfare Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hina Sharif, PharmD,MSPH (03373305666, hina.shf19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic and/or Diastolic Blood Pressure (time frame: 3, 6, 9 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.