Cardiovascular Diseases Clinical Trial
— SELECTOfficial title:
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.
Status | Not yet recruiting |
Enrollment | 2000 |
Est. completion date | September 2020 |
Est. primary completion date | September 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Aga Khan University | The George Institute |
Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. — View Citation
Jafar TH, Haaland BA, Rahman A, Razzak JA, Bilger M, Naghavi M, Mokdad AH, Hyder AA. Non-communicable diseases and injuries in Pakistan: strategic priorities. Lancet. 2013 Jun 29;381(9885):2281-90. doi: 10.1016/S0140-6736(13)60646-7. Epub 2013 May 17. — View Citation
Kamal AK, Khoja A, Usmani B, Muqeet A, Zaidi F, Ahmed M, Shakeel S, Soomro N, Gowani A, Asad N, Ahmed A, Sayani S, Azam I, Saleem S. Translating knowledge for action against stroke--using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke). Trials. 2016 Jan 27;17:52. doi: 10.1186/s13063-016-1175-x. — View Citation
Khan M, Kamal AK, Islam M, Azam I, Virk A, Nasir A, Rehman H, Arif A, Jan M, Akhtar A, Mawani M, Razzak JA, Pasha O. Can trained field community workers identify stroke using a stroke symptom questionnaire as well as neurologists? Adaptation and validation of a community worker administered stroke symptom questionnaire in a peri-urban Pakistani community. J Stroke Cerebrovasc Dis. 2015 Jan;24(1):91-9. doi: 10.1016/j.jstrokecerebrovasdis.2014.07.030. Epub 2014 Oct 16. — View Citation
Mohan V, Deepa R, Deepa M, Somannavar S, Datta M. A simplified Indian Diabetes Risk Score for screening for undiagnosed diabetic subjects. J Assoc Physicians India. 2005 Sep;53:759-63. — View Citation
Rahman MA, Spurrier N, Mahmood MA, Rahman M, Choudhury SR, Leeder S. Rose Angina Questionnaire: validation with cardiologists' diagnoses to detect coronary heart disease in Bangladesh. Indian Heart J. 2013 Jan-Feb;65(1):30-9. doi: 10.1016/j.ihj.2012.09.008. Epub 2012 Sep 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Health Service Delivery of Intervention Outreach via Short Text Messages | The success rate in delivery of SMS intervention to target community 1. Number of SMS sent successfully to target Population |
3 to 6 months | |
Primary | Health Service Delivery of Intervention Outreach via Interactive Voice Recording | Number of IVR ( Interactive Voice Recording ) sent to target Population | 3 to 6 months | |
Primary | Health Service Measures of Intervention Uptake | Proportion of referred participants enrolled in e_Prescription education program | 3 to 6 months | |
Primary | Community Participation and Uptake of Intervention | Number of participants responded to the IVR and SMS call | 3 to 6 months | |
Primary | Early Impact Measure of Intervention for Prompt Referral | Proportion of referred participants from screened participants referred | 3 to 6 months | |
Primary | Early Impact Measure of Intervention for Detection | 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 | Change in Physiological Characteristics of Intervention Participants - Blood Pressure | Mean difference in systolic and diastolic Blood Pressure before and after intervention in mm Hg. | 0, 3 to 6 months | |
Secondary | Change in Physiological Characteristics of Intervention Participants - Weight | Mean difference in weight before and after intervention in kg | 0, 3 to 6 months | |
Secondary | Change in Physiologic Characteristics of Intervention Participants- Height | Height in metres to determine Body Mass Index ( BMI ) | 0, 3 to 6 months | |
Secondary | Change in Physiological Characteristics of Intervention Participants - BMI | Mean difference in BMI before and after intervention in kg/m2 | 0, 3 to 6 months | |
Secondary | Change in Physiological Characteristics of Intervention Participants - Physical Activity | 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 |
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