Clinical trial NCT04082091: Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention
Official title: Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention in PakisTan(SELECT) - A Pilot Feasibility Study Using mHealth
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Cerebral Infarction
Type2 Diabetes Mellitus
Hypertension,Essential
Prevention
Keywords: mHealth
mixed method
feasibility study
Malir district
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: The George Institute
First posted: 2019-09-09
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Health Service Delivery of Intervention Outreach via Short Text Messages
timeFrame: 3 to 6 months
measure: Health Service Delivery of Intervention Outreach via Interactive Voice Recording
timeFrame: 3 to 6 months
measure: Health Service Measures of Intervention Uptake
timeFrame: 3 to 6 months
measure: Community Participation and Uptake of Intervention
timeFrame: 3 to 6 months
measure: Early Impact Measure of Intervention for Prompt Referral
timeFrame: 3 to 6 months
measure: Early Impact Measure of Intervention for Detection
timeFrame: 3 to 6 months
Secondary outcomes:
measure: Change in Physiological Characteristics of Intervention Participants - Blood Pressure
timeFrame: 0, 3 to 6 months
measure: Change in Physiological Characteristics of Intervention Participants - Weight
timeFrame: 0, 3 to 6 months
measure: Change in Physiologic Characteristics of Intervention Participants- Height
timeFrame: 0, 3 to 6 months
measure: Change in Physiological Characteristics of Intervention Participants - BMI
timeFrame: 0, 3 to 6 months
measure: Change in Physiological Characteristics of Intervention Participants - Physical Activity
timeFrame: 0, 3 to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Aga Khan University
name: Ayeesha Kamal, MD
role: PRINCIPAL_INVESTIGATOR
References:
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