SMS-based Mobile Health Intervention for Nutritional Status and Treatment Outcome Among TB Patients

Addis Ababa University

Status: Unknown

Conditions: Tuberculosis; Undernutrition

Treatments: Behavioral: SMS-based Mobile Health intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04242472

D43TW009127 (U.S. NIH Grant/Contract)

TB-MeNu

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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440 participants in 2 patient groups

SMS group

Experimental group

Description:

Nutrition-related SMS messages in addition to standard of care TB treatment with directly observed therapy

Treatment:

Behavioral: SMS-based Mobile Health intervention

Control group

No Intervention group

Description:

Standard care of TB treatment with directly observed therapy alone