Skip to main content
Clinical Trials/NCT04082091
NCT04082091
Unknown
Not Applicable

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

Aga Khan University0 sites2,000 target enrollmentSeptember 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Aga Khan University
Enrollment
2000
Primary Endpoint
Health Service Delivery of Intervention Outreach via Interactive Voice Recording
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2019
End Date
September 2020
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Ayeesha Kamran Kamal

Professor of Neurology, Department of Medicine

Aga Khan University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Health Service Delivery of Intervention Outreach via Interactive Voice Recording

Time Frame: 3 to 6 months

Number of IVR ( Interactive Voice Recording ) sent to target Population

Health Service Delivery of Intervention Outreach via Short Text Messages

Time Frame: 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

Time Frame: 3 to 6 months

Proportion of referred participants enrolled in e_Prescription education program

Early Impact Measure of Intervention for Prompt Referral

Time Frame: 3 to 6 months

Proportion of referred participants from screened participants referred

Community Participation and Uptake of Intervention

Time Frame: 3 to 6 months

Number of participants responded to the IVR and SMS call

Early Impact Measure of Intervention for Detection

Time Frame: 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 Outcomes

  • Change in Physiological Characteristics of Intervention Participants - Blood Pressure(0, 3 to 6 months)
  • Change in Physiologic Characteristics of Intervention Participants- Height(0, 3 to 6 months)
  • Change in Physiological Characteristics of Intervention Participants - Physical Activity(0, 3 to 6 months)
  • Change in Physiological Characteristics of Intervention Participants - Weight(0, 3 to 6 months)
  • Change in Physiological Characteristics of Intervention Participants - BMI(0, 3 to 6 months)

Similar Trials