NCT03580330

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,359

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
Last Updated

July 9, 2018

Status Verified

June 1, 2018

Enrollment Period

4 years

First QC Date

June 1, 2018

Last Update Submit

June 26, 2018

Conditions

Keywords

noncommunicable diseaseshypertensiondiabetes mellitustelemedicinemobile healthrural healthrefugees

Outcome Measures

Primary Outcomes (2)

  • Blood Pressure Control (blood pressure (SBP/DBP) <140/90 mmHg))

    blood pressure (SBP/DBP) \<140/90 mmHg

    At 1 year from the time of initiation of the intervention

  • Mean HbA1c

    HbA1c level assessed for each patient

    At 1 year from the time of initiation of the intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL
Other: mHealth intervention

Control Group

NO INTERVENTION

Interventions

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).

Intervention Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • aged less than 40 years
  • Non-Lebanese / Non-Palestinian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Diabetes MellitusHypertensionNoncommunicable Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Global Health Institute

Study Record Dates

First Submitted

June 1, 2018

First Posted

July 9, 2018

Study Start

April 17, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

July 9, 2018

Record last verified: 2018-06