Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention

Study Overview
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Brief Summary
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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
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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.

Official Title
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Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention in PakisTan(SELECT) - A Pilot Feasibility Study Using mHealth

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

Intervention / Treatment
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* Behavioral: SELECT mHealth Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: SELECT mHealth Program|Individuals will be screened via the telephone, using a mobile-based algorithm that prompts questions about hypertension, risk of Diabetes Mellitus, use of smokeless tobacco and smoking, level of physical activity, and main nutritional choices. These questions are based on tools that have been validated in studies undertaken in this population and will be directly administered by trained research staff of Aga Khan University. Screening will prompt triage into three categories: high - referred to the conveniently located integrated medical center for a medical teleconsultation and fasting glucose test; medium - receive fasting glucose test and BP measurement; and low risk. All subjects in each category will be enrolled in an e_Prescription intervention for lifestyle change tailored to their individual risk profile.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Service Delivery of Intervention Outreach via Short Text Messages | The success rate in delivery of SMS intervention to target community 1. Number of SMS sent successfully to target Population | 3 to 6 months | 
| Health Service Delivery of Intervention Outreach via Interactive Voice Recording | Number of IVR ( Interactive Voice Recording ) sent to target Population | 3 to 6 months | 
| Health Service Measures of Intervention Uptake | Proportion of referred participants enrolled in e_Prescription education program | 3 to 6 months | 
| Community Participation and Uptake of Intervention | Number of participants responded to the IVR and SMS call | 3 to 6 months | 
| Early Impact Measure of Intervention for Prompt Referral | Proportion of referred participants from screened participants referred | 3 to 6 months | 
| Early Impact Measure of Intervention for Detection | 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 | 3 to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physiological Characteristics of Intervention Participants - Blood Pressure | Mean difference in systolic and diastolic Blood Pressure before and after intervention in mm Hg. | 0, 3 to 6 months | 
| Change in Physiological Characteristics of Intervention Participants - Weight | Mean difference in weight before and after intervention in kg | 0, 3 to 6 months | 
| Change in Physiologic Characteristics of Intervention Participants- Height | Height in metres to determine Body Mass Index ( BMI ) | 0, 3 to 6 months | 
| Change in Physiological Characteristics of Intervention Participants - BMI | Mean difference in BMI before and after intervention in kg/m2 | 0, 3 to 6 months | 
| Change in Physiological Characteristics of Intervention Participants - Physical Activity | 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. | 0, 3 to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mHealth, mixed method, feasibility study, Malir district