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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2021-03-31

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.

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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.

Conditions

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Tuberculosis Undernutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Cluster Randomized Trial (CRT) with parallel design will be employed.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Participants and providers will not be blind to the study intervention. Nutrition and tuberculosis treatment outcomes will be assessed by two independent reviewers without knowledge of each participant's treatment allocation.

Study Groups

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SMS group

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

Group Type EXPERIMENTAL

SMS-based Mobile Health intervention

Intervention Type BEHAVIORAL

Nutritional related SMS text message mobile health intervention will be provided to Tuberculosis patients.

Control group

Standard care of TB treatment with directly observed therapy alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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