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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04082091
Other study ID # 2019-0599-2619
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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