SELECT: Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention

Sponsor

Aga Khan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04082091

Collaborator

The George Institute (Other)

2,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Diseases Cerebral Infarction Type2 Diabetes Mellitus Hypertension,Essential Prevention	Behavioral: SELECT mHealth Program

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 Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Ecologic or Community

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 1, 2020

Outcome Measures

Primary Outcome Measures

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 Delivery of Intervention Outreach via Interactive Voice Recording [3 to 6 months]
Number of IVR ( Interactive Voice Recording ) sent to target Population
Health Service Measures of Intervention Uptake [3 to 6 months]
Proportion of referred participants enrolled in e_Prescription education program
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 Prompt Referral [3 to 6 months]
Proportion of referred participants from screened participants referred
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

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 Physiological Characteristics of Intervention Participants - Weight [0, 3 to 6 months]
Mean difference in weight before and after intervention in kg
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 - BMI [0, 3 to 6 months]
Mean difference in BMI before and after intervention in kg/m2
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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