Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention

Cardiovascular Diseases Clinical Trial

— SELECT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04082091
• Other study ID #: 2019-0599-2619
• Status: Not yet recruiting
• Start date: September 2019
• Est. completion date: September 2020

Study information

• Verified date: September 2019
• Source: Aga Khan University
• Contact: Ayeesha Kamal, MD
• Phone: +9221-34930051
• Email: ayeesha.kamal[@]aku.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	The George Institute

References & Publications (6)

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

Outcome

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