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Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention (SELECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082091
Recruitment Status : Not yet recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Collaborator:
The George Institute
Information provided by (Responsible Party):
Dr. Ayeesha Kamran Kamal, Aga Khan University

Brief 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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Cerebral Infarction Type2 Diabetes Mellitus Hypertension,Essential Prevention Behavioral: SELECT mHealth Program

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Screening, Early Referral and Lifestyle Tailored E_prescription for Cardiovascular Prevention in PakisTan(SELECT) - A Pilot Feasibility Study Using mHealth
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Health Service Delivery of Intervention Outreach via Short Text Messages [ Time Frame: 3 to 6 months ]

    The success rate in delivery of SMS intervention to target community

    1. Number of SMS sent successfully to target Population


  2. Health Service Delivery of Intervention Outreach via Interactive Voice Recording [ Time Frame: 3 to 6 months ]
    Number of IVR ( Interactive Voice Recording ) sent to target Population

  3. Health Service Measures of Intervention Uptake [ Time Frame: 3 to 6 months ]
    Proportion of referred participants enrolled in e_Prescription education program

  4. Community Participation and Uptake of Intervention [ Time Frame: 3 to 6 months ]
    Number of participants responded to the IVR and SMS call

  5. Early Impact Measure of Intervention for Prompt Referral [ Time Frame: 3 to 6 months ]
    Proportion of referred participants from screened participants referred

  6. Early Impact Measure of Intervention for Detection [ Time Frame: 3 to 6 months ]

    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



Secondary Outcome Measures :
  1. Change in Physiological Characteristics of Intervention Participants - Blood Pressure [ Time Frame: 0, 3 to 6 months ]
    Mean difference in systolic and diastolic Blood Pressure before and after intervention in mm Hg.

  2. Change in Physiological Characteristics of Intervention Participants - Weight [ Time Frame: 0, 3 to 6 months ]
    Mean difference in weight before and after intervention in kg

  3. Change in Physiologic Characteristics of Intervention Participants- Height [ Time Frame: 0, 3 to 6 months ]
    Height in metres to determine Body Mass Index ( BMI )

  4. Change in Physiological Characteristics of Intervention Participants - BMI [ Time Frame: 0, 3 to 6 months ]
    Mean difference in BMI before and after intervention in kg/m2

  5. Change in Physiological Characteristics of Intervention Participants - Physical Activity [ Time Frame: 0, 3 to 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082091


Contacts
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Contact: Ayeesha Kamal, MD +9221-34930051 ext 4669 ayeesha.kamal@aku.edu
Contact: Adeel Khoja, MSc +9221-34930051 ext 4993 adeel.khoja@aku.edu

Sponsors and Collaborators
Aga Khan University
The George Institute
Investigators
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Principal Investigator: Ayeesha Kamal, MD Aga Khan University
Publications:

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Responsible Party: Dr. Ayeesha Kamran Kamal, Professor of Neurology, Department of Medicine, Aga Khan University
ClinicalTrials.gov Identifier: NCT04082091    
Other Study ID Numbers: 2019-0599-2619
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Ayeesha Kamran Kamal, Aga Khan University:
mHealth
mixed method
feasibility study
Malir district
Additional relevant MeSH terms:
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Cerebral Infarction
Essential Hypertension
Infarction
Cardiovascular Diseases
Hypertension
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke