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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03580330
Other study ID # FHS.SS.11
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 17, 2014
Est. completion date April 1, 2018

Study information

Verified date June 2018
Source American University of Beirut Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2359
Est. completion date April 1, 2018
Est. primary completion date April 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
American University of Beirut Medical Center International Development Research Centre, Canada, Ministry of Public Health (MOPH), Lebanon, United Nations Relief and Works Agency (UNRWA)

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Mean HbA1c HbA1c level assessed for each patient At 1 year from the time of initiation of the intervention
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