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

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ClinicalTrials.gov Identifier: NCT03580330
Recruitment Status : Completed
First Posted : July 9, 2018
Last Update Posted : July 9, 2018
Sponsor:
Collaborators:
International Development Research Centre, Canada
Ministry of Public Health (MOPH), Lebanon
United Nations Relief and Works Agency (UNRWA)
Information provided by (Responsible Party):
Shadi Saleh, American University of Beirut Medical Center

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Hypertension Other: mHealth intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2359 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: Could Low-Cost Mobile Health Interventions Make a Difference?:Enhancing Outcomes of Noncommunicable Diseases Care in Rural Settings and Refugee Camps
Actual Study Start Date : April 17, 2014
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group Other: mHealth intervention
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).

No Intervention: Control Group



Primary Outcome Measures :
  1. Blood Pressure Control (blood pressure (SBP/DBP) <140/90 mmHg)) [ Time Frame: At 1 year from the time of initiation of the intervention ]
    blood pressure (SBP/DBP) <140/90 mmHg

  2. Mean HbA1c [ Time Frame: At 1 year from the time of initiation of the intervention ]
    HbA1c level assessed for each patient



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shadi Saleh, Director, Global Health Institute, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03580330     History of Changes
Other Study ID Numbers: FHS.SS.11
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: June 2018
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 Shadi Saleh, American University of Beirut Medical Center:
noncommunicable diseases
hypertension
diabetes mellitus
telemedicine
mobile health
rural health
refugees
Additional relevant MeSH terms:
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Hypertension
Diabetes Mellitus
Noncommunicable Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Chronic Disease
Disease Attributes
Pathologic Processes