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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tuberculosis, Undernutrition

Intervention / Treatment
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* Behavioral: SMS-based Mobile Health intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Cluster Randomized Trial (CRT) with parallel design will be employed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMS group<br>Nutrition-related SMS messages in addition to standard of care TB treatment with directly observed therapy | Behavioral: SMS-based Mobile Health intervention<br>* Nutritional related SMS text message mobile health intervention will be provided to Tuberculosis patients.<br>|
| No Intervention: Control group<br>Standard care of TB treatment with directly observed therapy alone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tuberculosis, Nutrition, Treatment outcome, SMS