Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention

NCT ID: NCT04082091

Last Updated: 2019-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases Cerebral Infarction Type2 Diabetes Mellitus Hypertension,Essential Prevention

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The George Institute

OTHER

Sponsor Role collaborator

Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ayeesha Kamran Kamal

Professor of Neurology, Department of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayeesha Kamal, MD

Role: PRINCIPAL_INVESTIGATOR

Aga Khan University

Central Contacts

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Ayeesha Kamal, MD

Role: CONTACT

+9221-34930051 ext. 4669

Adeel Khoja, MSc

Role: CONTACT

+9221-34930051 ext. 4993

References

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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.

Reference Type BACKGROUND
PMID: 23684257 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26818913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16334618 (View on PubMed)

Craig CL, Marshall AL, Sjostrom 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. doi: 10.1249/01.MSS.0000078924.61453.FB.

Reference Type BACKGROUND
PMID: 12900694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25440346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23438610 (View on PubMed)

Other Identifiers

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2019-0599-2619

Identifier Type: -

Identifier Source: org_study_id

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