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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04082091
Acronym
SELECT
Enrollment
2000
Registered
2019-09-09
Start date
2019-09-30
Completion date
2020-09-30
Last updated
2019-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

mHealth, mixed method, feasibility study, Malir district

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.

Interventions

BEHAVIORALSELECT 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.

Sponsors

The George Institute
CollaboratorOTHER
Aga Khan University
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Early Impact Measure of Intervention for Detection3 to 6 monthsProportion 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
Health Service Delivery of Intervention Outreach via Short Text Messages3 to 6 monthsThe 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 Recording3 to 6 monthsNumber of IVR ( Interactive Voice Recording ) sent to target Population
Health Service Measures of Intervention Uptake3 to 6 monthsProportion of referred participants enrolled in e\_Prescription education program
Community Participation and Uptake of Intervention3 to 6 monthsNumber of participants responded to the IVR and SMS call
Early Impact Measure of Intervention for Prompt Referral3 to 6 monthsProportion of referred participants from screened participants referred

Secondary

MeasureTime frameDescription
Change in Physiological Characteristics of Intervention Participants - Weight0, 3 to 6 monthsMean difference in weight before and after intervention in kg
Change in Physiologic Characteristics of Intervention Participants- Height0, 3 to 6 monthsHeight in metres to determine Body Mass Index ( BMI )
Change in Physiological Characteristics of Intervention Participants - BMI0, 3 to 6 monthsMean difference in BMI before and after intervention in kg/m2
Change in Physiological Characteristics of Intervention Participants - Physical Activity0, 3 to 6 monthsIncrease 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.
Change in Physiological Characteristics of Intervention Participants - Blood Pressure0, 3 to 6 monthsMean difference in systolic and diastolic Blood Pressure before and after intervention in mm Hg.

Contacts

Primary ContactAyeesha Kamal, MD
ayeesha.kamal@aku.edu+9221-34930051
Backup ContactAdeel Khoja, MSc
adeel.khoja@aku.edu+9221-34930051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026