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

September 6, 2019 updated by: Dr. Ayeesha Kamran Kamal, Aga Khan University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The pilot study will be undertaken in the Malir area (80,000 persons), one of the largest districts of Karachi (population 120 million), with urban, urban slum, and rural urban areas, and includes all ethnicities and economic strata of Pakistan. In this location, the Aga Khan University Health System, one of the major health systems of Pakistan, has integrated medical centers (IMSs) with laboratory testing, resident physicians, and ability to triage and refer people to a main tertiary hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 to 6 months
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
3 to 6 months
Health Service Measures of Intervention Uptake
Time Frame: 3 to 6 months
Proportion of referred participants enrolled in e_Prescription education program
3 to 6 months
Community Participation and Uptake of Intervention
Time Frame: 3 to 6 months
Number of participants responded to the IVR and SMS call
3 to 6 months
Early Impact Measure of Intervention for Prompt Referral
Time Frame: 3 to 6 months
Proportion of referred participants from screened participants referred
3 to 6 months
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
3 to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physiological Characteristics of Intervention Participants - Blood Pressure
Time Frame: 0, 3 to 6 months
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
Time Frame: 0, 3 to 6 months
Mean difference in weight before and after intervention in kg
0, 3 to 6 months
Change in Physiologic Characteristics of Intervention Participants- Height
Time Frame: 0, 3 to 6 months
Height in metres to determine Body Mass Index ( BMI )
0, 3 to 6 months
Change in Physiological Characteristics of Intervention Participants - BMI
Time Frame: 0, 3 to 6 months
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
Time Frame: 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.
0, 3 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

The George Institute

Investigators

  • Principal Investigator: Ayeesha Kamal, MD, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 6, 2019

First Posted (Actual)

September 9, 2019

Study Record Updates

Last Update Posted (Actual)

September 9, 2019

Last Update Submitted That Met QC Criteria

September 6, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-0599-2619

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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