Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention (SELECT)
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|ClinicalTrials.gov Identifier: NCT04082091|
Recruitment Status : Not yet recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
|Condition or disease||Intervention/treatment|
|Cardiovascular Diseases Cerebral Infarction Type2 Diabetes Mellitus Hypertension,Essential Prevention||Behavioral: SELECT mHealth Program|
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|
|Estimated Enrollment :||2000 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention in PakisTan(SELECT) - A Pilot Feasibility Study Using mHealth|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
- 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.
- 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 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 Measures of Intervention Uptake [ Time Frame: 3 to 6 months ]Proportion of referred participants enrolled in e_Prescription education program
- 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 Prompt Referral [ Time Frame: 3 to 6 months ]Proportion of referred participants from screened participants referred
- 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
- 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.
- 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
- Change in Physiologic Characteristics of Intervention Participants- Height [ Time Frame: 0, 3 to 6 months ]Height in metres to determine Body Mass Index ( BMI )
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082091
|Contact: Ayeesha Kamal, MD||+9221-34930051 ext firstname.lastname@example.org|
|Contact: Adeel Khoja, MSc||+9221-34930051 ext email@example.com|
|Principal Investigator:||Ayeesha Kamal, MD||Aga Khan University|