NCT04242472

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

SMS-based Mobile Health Intervention for Nutritional Status and Treatment Outcomes Among TB Patients in Addis Ababa, Ethiopia: A Cluster Randomized Trial (CRT)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: Addis Ababa University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tuberculosis
• Undernutrition

Interventions

Type	Name	Description
BEHAVIORAL	SMS-based Mobile Health intervention	Nutritional related SMS text message mobile health intervention will be provided to Tuberculosis patients.

Timeline

• Start date: 2020-07-01
• Primary completion: 2020-09-01
• Completion: 2021-03-01
• First posted: 2020-01-27
• Last updated: 2020-01-27

Locations

1 site across 1 country: Ethiopia