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Use of Low-cost mHealth Intervention to Enhance Outcomes of Noncommunicable Diseases Care in Rural and Refugee Settings

Primary Purpose

Diabetes Mellitus, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mHealth intervention
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus focused on measuring noncommunicable diseases, hypertension, diabetes mellitus, telemedicine, mobile health, rural health, refugees

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Registered at the Primary Healthcare Center as diabetics and/or hypertensive or diagnosed with or suspected to have diabetes and/or hypertension
  • Aged 40 years or more
  • Lebanese or Palestinian nationality

Exclusion Criteria:

  • aged less than 40 years
  • Non-Lebanese / Non-Palestinian
  • No exclusion based on gender, educational and literacy level, disability, or presence of other medical conditions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Blood Pressure Control (blood pressure (SBP/DBP) <140/90 mmHg))
    blood pressure (SBP/DBP) <140/90 mmHg
    Mean HbA1c
    HbA1c level assessed for each patient

    Secondary Outcome Measures

    Full Information

    First Posted
    June 1, 2018
    Last Updated
    June 26, 2018
    Sponsor
    American University of Beirut Medical Center
    Collaborators
    International Development Research Centre, Canada, Ministry of Public Health (MOPH), Lebanon, United Nations Relief and Works Agency (UNRWA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03580330
    Brief Title
    Use of Low-cost mHealth Intervention to Enhance Outcomes of Noncommunicable Diseases Care in Rural and Refugee Settings
    Official Title
    Could Low-Cost Mobile Health Interventions Make a Difference?:Enhancing Outcomes of Noncommunicable Diseases Care in Rural Settings and Refugee Camps
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 17, 2014 (Actual)
    Primary Completion Date
    April 1, 2018 (Actual)
    Study Completion Date
    April 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    American University of Beirut Medical Center
    Collaborators
    International Development Research Centre, Canada, Ministry of Public Health (MOPH), Lebanon, United Nations Relief and Works Agency (UNRWA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Rural areas and refugee camps are characterized by poor access of patients to needed noncommunicable disease (NCD)-related health services, including diabetes and hypertension. This community trial study aims to assess the effect of employing low-cost mHealth tools on the accessibility to health services and improvement of health indicators of individuals with NCDs in rural areas and refugee camps in Lebanon.
    Detailed Description
    Rural areas and refugee camps are characterized by poor access of patients to needed noncommunicable disease (NCD)-related health services, including diabetes and hypertension. Employing low-cost innovative eHealth interventions, such as mobile health (mHealth), may help improve NCDs prevention and control among disadvantaged populations. The aim of this study was to assess the effect of employing low-cost mHealth tools on the accessibility to health services and improvement of health indicators of individuals with NCDs in rural areas and refugee camps in Lebanon. This is a community trial study in which centers were allocated randomly into control and intervention sites. The effect of an employed mHealth intervention is assessed through selected quality indicators examined in both control and intervention groups. Sixteen primary health care centers (eight controls, eight interventions) located in rural areas and Palestinian refugee camps across Lebanon were included in this study. Data on diabetic and hypertensive patients-1433 in the intervention group and 926 in the control group-was extracted from patient files in the pre and postintervention periods. The intervention entailed weekly short message service messages, including medical information, importance of compliance, and reminders of appointments or regular physician follow-up. Internationally established care indicators were utilized in this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Hypertension
    Keywords
    noncommunicable diseases, hypertension, diabetes mellitus, telemedicine, mobile health, rural health, refugees

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This study reports on a community trial in which PHC centers, along their respective catchment areas, were randomly allocated into control and intervention sites with the aim of assessing the change in selected NCD care quality indicators (QIs) among community individuals and patients. Patients in the intervention sites received a 1-year mHealth intervention, and their pre- and postintervention outcomes were assessed through measurement of QIs. Patients in the control sites received no intervention.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    2359 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Title
    Control Group
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    mHealth intervention
    Intervention Description
    Individual in the intervention group receive a weekly educational health SMS for the intervention period of 1 year. SMS content covered different health themes providing health information on lifestyle, dietary habits, body weight, smoking, medications, importance of compliance, as well as symptoms and self-management of HTN and diabetes. Community individuals who were diagnosed and were receiving necessary care previous to the investigator's intervention were sent weekly informative health SMS, as well as customized SMSs reminders to follow up on their scheduled medical appointments (eg, to check their HbA1c levels and have their annual foot or eye exams).
    Primary Outcome Measure Information:
    Title
    Blood Pressure Control (blood pressure (SBP/DBP) <140/90 mmHg))
    Description
    blood pressure (SBP/DBP) <140/90 mmHg
    Time Frame
    At 1 year from the time of initiation of the intervention
    Title
    Mean HbA1c
    Description
    HbA1c level assessed for each patient
    Time Frame
    At 1 year from the time of initiation of the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Registered at the Primary Healthcare Center as diabetics and/or hypertensive or diagnosed with or suspected to have diabetes and/or hypertension Aged 40 years or more Lebanese or Palestinian nationality Exclusion Criteria: aged less than 40 years Non-Lebanese / Non-Palestinian No exclusion based on gender, educational and literacy level, disability, or presence of other medical conditions

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    33769555
    Citation
    Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.
    Results Reference
    derived
    PubMed Identifier
    30006326
    Citation
    Saleh S, Farah A, Dimassi H, El Arnaout N, Constantin J, Osman M, El Morr C, Alameddine M. Using Mobile Health to Enhance Outcomes of Noncommunicable Diseases Care in Rural Settings and Refugee Camps: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jul 13;6(7):e137. doi: 10.2196/mhealth.8146.
    Results Reference
    derived

    Learn more about this trial

    Use of Low-cost mHealth Intervention to Enhance Outcomes of Noncommunicable Diseases Care in Rural and Refugee Settings

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