Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention

• Conditions: Hypertension,Essential; Prevention; Cerebral Infarction; Type2 Diabetes Mellitus; Cardiovascular Diseases

• Registration Number: NCT04082091
• Lead Sponsor: Aga Khan University

Brief Summary

We will evaluate an e_Prescription intervention can be integrated into an electronic screening program, which together exploit: (i) reach - the adult population has 100% mobile phone ownership and 92% internet national coverage; and (ii) behavioral change - the intervention can teach verbally and visually, thus bypassing literacy challenges, to allow simple, low-cost, repetition messaging for habit reinforcement. Uptake of the program through the various stages will be evaluated in \~2000 adults of a large representative suburban district of Karachi: As well as before-and-after physiological measures, including blood pressure (BP) and blood glucose, a random sample of 30-40 participants will be invited for interview to assess success and failure of the program. This is a pragmatic feasibility intervention implementation study.

Detailed Description

The goal of this pilot study is to demonstrate feasibility of a scalable , population-wide, approach to early detection and management of people at high-risk of CVD using electronic screening, referral, treatment and lifestyle modification based on health theory and considerable background research for local applicability.

It is a mixed method, feasibility study based in Malir District of Karachi, the largest city in Pakistan, to demonstrate uptake, participation and response of our mHealth intervention.

Study Timeline

• Status Verified: 2019-09
• Study Start: 2019-09
• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-06
• Last Update Submitted: 2019-09-06
• Study First Posted: 2019-09-09
• Last Update Posted: 2019-09-09
• Primary Completion: 2020-09
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• All adult (>18 years) residents of Malir district
• Own a mobile phone
• Provide written informed consent are eligible to participate

Exclusion Criteria

• Not permanent residents of Malir district.
• A person who is decision impaired due to stroke, or aphasia or dementia .
• Serious cognitive deficits that impair the visualization or understanding of SMS, IVR and e_prescription messages

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health Service Delivery of Intervention Outreach via Interactive Voice Recording	3 to 6 months	Number of IVR ( Interactive Voice Recording ) sent to target Population
Health Service Delivery of Intervention Outreach via Short Text Messages	3 to 6 months	The success rate in delivery of SMS intervention to target community; 1. Number of SMS sent successfully to target Population
Health Service Measures of Intervention Uptake	3 to 6 months	Proportion of referred participants enrolled in e_Prescription education program
Early Impact Measure of Intervention for Prompt Referral	3 to 6 months	Proportion of referred participants from screened participants referred
Community Participation and Uptake of Intervention	3 to 6 months	Number of participants responded to the IVR and SMS call
Early Impact Measure of Intervention for Detection	3 to 6 months	Proportion of participants in each of risk strata (low, medium and high risk) as defined by; the presence of stroke and/or MI ( High ), DM and / or HTN ( Medium), or poor lifestyle choices ( Low Risk) by the SELECT algorithm

Secondary Outcome Measures

Name	Time	Method
Change in Physiological Characteristics of Intervention Participants - Blood Pressure	0, 3 to 6 months	Mean difference in systolic and diastolic Blood Pressure before and after intervention in mm Hg.
Change in Physiologic Characteristics of Intervention Participants- Height	0, 3 to 6 months	Height in metres to determine Body Mass Index ( BMI )
Change in Physiological Characteristics of Intervention Participants - Physical Activity	0, 3 to 6 months	Increase in number of hours in physical activity from baseline (self-reported) measured by the IPAQ Short scale self reported version ( International Physical Activity Questionnaire) which will report low medium and high levels of physical activity based on 600 MET minutes /week ( Moderate),1500- 3000 MET minutes /week ( High), and low as any value less than the above.
Change in Physiological Characteristics of Intervention Participants - Weight	0, 3 to 6 months	Mean difference in weight before and after intervention in kg
Change in Physiological Characteristics of Intervention Participants - BMI	0, 3 to 6 months	Mean difference in BMI before and after intervention in kg/m2