NCT04082091

Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-09-01
• Completion: 2020-09-01
• First posted: 2019-09-09
• Last updated: 2019-09-09