Clinical trial NCT04242472: SMS-based Mobile Health Intervention for Nutritional Status and Treatment Outcome Among TB Patients
Official title: SMS-based Mobile Health Intervention for Nutritional Status and Treatment Outcomes Among TB Patients in Addis Ababa, Ethiopia: A Cluster Randomized Trial (CRT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis
Undernutrition
Keywords: Tuberculosis
Nutrition
Treatment outcome
SMS
Lead sponsor: Addis Ababa University
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2020-01-27
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Cluster Randomized Trial (CRT) with parallel design will be employed.
Primary purpose: OTHER

Brief summary: Ethiopia is one of the high burden Tuberculosis countries and Tuberculosis is still the leading cause of mortality due to communicable diseases in the country. Nutritional status is one of the predictors of TB treatment outcomes. Thus, the current practices need integration of nutritional intervention in the DOT using Mobile health intervention. However, to investigator's knowledge, there is no sufficient evidence on the effect SMS text Messaging Mobile Health intervention on nutritional status and TB treatment outcomes in Ethiopia.

Detailed description: To ensure the quality of SMS intervention, nutritional related SMS text message will be developed systematically through reviewing literature, systematic reviews and guidelines and appropriate behavioral theories by involving experts and patients. Automated SMS will be sent from one computer database at the scheduled date and time. A validated questionnaire will be adapted and pre-tested to check for any error. Adequate sample size is calculated for both arms with the ratio of 1:1 allocation. Standardized Anthropometric measurement, FANTA Household Dietary Diversity Score and WHO TB treatment outcome classification will be used for assessing the outcome variables. The data collectors will be trained on the objective, screening of eligible participants, the procedure of data collection, and how to assure the quality and security of the data based on the protocol. Continuous supervision will be employed throughout the data collection and intervention period. The data will be collected electronically and will be exported to STATA for analysis. Intention to treat analysis and regression analysis model will be employed.

Eligibility criteria: Inclusion Criteria:

* Patient who is following their anti TB treatment for at most two weeks and below
* Patient who have their own mobile phone
* Patient who is able to read and understand national official language (Amharic)

Exclusion Criteria:

* Patient whose TB treatment regimen more than 6 months
* Patient who is pregnant and lactating mothers
* Patient who enrolled other Interventional research

Primary outcomes:
measure: Nutritional status change
timeFrame: Change from baseline BMI at end of 2 months and 6 months treatment
Secondary outcomes:
measure: Dietary practice change
timeFrame: Change from baseline dietary practice at end of 6 months treatment
measure: Treatment outcome
timeFrame: End of six months TB treatment
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Addis Ababa Health Bureau
Study officials:
affiliation: Addis Ababa University School of Public Health
name: Damen Haile Mariam
role: STUDY_CHAIR
References: