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
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
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
NCT ID
NCT03580330
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)
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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