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

June 26, 2018 updated by: Shadi Saleh, American University of Beirut Medical Center

Could Low-Cost Mobile Health Interventions Make a Difference?:Enhancing Outcomes of Noncommunicable Diseases Care in Rural Settings and Refugee Camps

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2359

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 1 year from the time of initiation of the intervention
Mean HbA1c
Time Frame: At 1 year from the time of initiation of the intervention
HbA1c level assessed for each patient
At 1 year from the time of initiation of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2014

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

June 1, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

July 9, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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