Clinical trial NCT03580330: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hypertension
Keywords: noncommunicable diseases
hypertension
diabetes mellitus
telemedicine
mobile health
rural health
refugees
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: International Development Research Centre, Canada
name: Ministry of Public Health (MOPH), Lebanon
name: United Nations Relief and Works Agency (UNRWA)
First posted: 2018-07-09
Enrollment: 2359
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Blood Pressure Control (blood pressure (SBP/DBP) <140/90 mmHg))
timeFrame: At 1 year from the time of initiation of the intervention
measure: Mean HbA1c
timeFrame: At 1 year from the time of initiation of the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
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.