- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07131176
- Original Trial
Assessing the Feasibility of Multimedia Interventions to Reduce Blood Pressure in Marginalized Hypertensive Communities of Karachi, Pakistan
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hina Sharif, PharmD,MSPH
- Phone Number: 03373305666
- Email: hina.shf19@gmail.com
Study Contact Backup
- Name: Sana S Sheikh, MSc. MPH
- Email: sanshf4@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
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.
|
|
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.
|
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.
|
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3, 6, 9 months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in hypertension knowledge score
Time Frame: at 3, 6, 9 months post intervention
|
From baseline to post intervention, knowledge about self-care among interventional arms
|
at 3, 6, 9 months post intervention
|
|
Adherence to antihypertensive medication
Time Frame: at 3, 6, 9 months post intervention
|
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
|
at 3, 6, 9 months post intervention
|
|
Dietary modifications (e.g., reduced salt intake)
Time Frame: 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
Time Frame: 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
Time Frame: 3,6,9 months post intervention
|
weight control according to height in kg/m2
|
3,6,9 months post intervention
|
|
Smoking control (number of cigarettes per day)
Time Frame: 3, 6, 9 months post intervention
|
Smoking control starting from reduction in number of cigarettes per day to complete cessation
|
3, 6, 9 months post intervention
|
|
Physical activity
Time Frame: 3, 6, 9 months intervention
|
time in minutes which shows physically active in a day (in term of walking, yoga, exercise)
|
3, 6, 9 months intervention
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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