AzTrials
AzTrials

Cardiovascular DiseasesSELECTNCT04082091

Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention

An observational study of Cardiovascular Diseases and Cerebral Infarction, run by Aga Khan University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
What is being tested?
SELECT mHealth Program
How many people
2,000 participants
Where
No sites listed yet
Study dates
Sep 2019to Sep 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The pilot study will be undertaken in the Malir area (80,000 persons), one of the largest districts of Karachi (population 120 million), with urban, urban slum, and rural urban areas, and includes all ethnicities and economic strata of Pakistan. In this location, the Aga Khan University Health System, one of the major health systems of Pakistan, has integrated medical centers (IMSs) with laboratory testing, resident physicians, and ability to triage and refer people to a main tertiary hospital.

Who may be able to join

  • All adult (>18 years) residents of Malir district
  • Own a mobile phone
  • Provide written informed consent are eligible to participate

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Ayeesha Kamal, MD contact

+9221-34930051 ext. 4669

ayeesha.kamal@aku.edu

Adeel Khoja, MSc contact

+9221-34930051 ext. 4993

adeel.khoja@aku.edu

About this study

Official 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.

Read the detailed 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.

Being tested
SELECT mHealth Program
Keywords
mHealth, mixed method, feasibility study, Malir district
Medical subject headings
Cardiovascular Diseases, Cerebral Infarction, Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SELECT mHealth ProgramBehavioural

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 to 6 months

  2. Health Service Delivery of Intervention Outreach via Interactive Voice Recording

    Number of IVR ( Interactive Voice Recording ) sent to target Population

    Measured: 3 to 6 months

  3. Health Service Measures of Intervention Uptake

    Proportion of referred participants enrolled in e_Prescription education program

    Measured: 3 to 6 months

  4. Community Participation and Uptake of Intervention

    Number of participants responded to the IVR and SMS call

    Measured: 3 to 6 months

  5. Early Impact Measure of Intervention for Prompt Referral

    Proportion of referred participants from screened participants referred

    Measured: 3 to 6 months

  6. 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

    Measured: 3 to 6 months

Secondary outcomes (5)

  1. Change in Physiological Characteristics of Intervention Participants - Blood Pressure

    Mean difference in systolic and diastolic Blood Pressure before and after intervention in mm Hg.

    Measured: 0, 3 to 6 months

  2. Change in Physiological Characteristics of Intervention Participants - Weight

    Mean difference in weight before and after intervention in kg

    Measured: 0, 3 to 6 months

  3. Change in Physiologic Characteristics of Intervention Participants- Height

    Height in metres to determine Body Mass Index ( BMI )

    Measured: 0, 3 to 6 months

  4. Change in Physiological Characteristics of Intervention Participants - BMI

    Mean difference in BMI before and after intervention in kg/m2

    Measured: 0, 3 to 6 months

  5. 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.

    Measured: 0, 3 to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2019
  2. Study startSep 2019 (estimated)
  3. Primary completionSep 2020 (estimated)
  4. Study completionSep 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04082091
Sponsor's protocol ID
2019-0599-2619
Acronym
SELECT
Status last verified
Sep 2019
First submitted
3 Sep 2019
Last updated
9 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23684257

  • 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.

    PubMed 26818913

  • 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.

    PubMed 16334618

  • 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.

    PubMed 12900694

  • 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.

    PubMed 25440346

  • 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.

    PubMed 23438610

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Cerebral Infarction, run by Aga Khan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ayeesha Kamal, MD (+9221-34930051 ext. 4669, ayeesha.kamal@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Service Delivery of Intervention Outreach via Short Text Messages (time frame: 3 to 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04082091, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in