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

Tuberculosis Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04242472
• Other study ID #: TB-MeNu
• Secondary ID: D43TW009127
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2020
• Est. completion date: March 2021

Study information

• Verified date: January 2020
• Source: Addis Ababa University
• Contact: Zekariyas Sa Nezenega
• Phone: 911072963
• Email: zekitiru[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 440
• Est. completion date: March 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Tuberculosis
• Undernutrition

Intervention

Behavioral:
• SMS-based Mobile Health intervention
Nutritional related SMS text message mobile health intervention will be provided to Tuberculosis patients.

Locations

Country	Name	City	State
Ethiopia	Addis Ababa Health Bureau	Addis Ababa

Sponsors (2)

Lead Sponsor	Collaborator
Addis Ababa University	John E. Fogarty International Center (FIC)

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status change	The nutritional status of the patient will be assessed by Body Mass Index (BMI) that calculated through measuring the body weight and height of the patients using an electronic platform weight scale to the nearest 0.1 kg and height to the nearest centimeter using standardized meter.	Change from baseline BMI at end of 2 months and 6 months treatment
Secondary	Dietary practice change	Patient's dietary diversity practice will be assessed through a standardized tool adapted from FANTA Household Dietary Diversity Score	Change from baseline dietary practice at end of 6 months treatment
Secondary	Treatment outcome	Treatment outcomes will be classified as per WHO Tuberculosis treatment guideline. The classification is made based on the smear sputum examination result at second, five and end of six months treatment and/or treatment completion status.	End of six months TB treatment