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

Sponsor
Addis Ababa University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04242472
Collaborator
Fogarty International Center of the National Institute of Health (NIH)
440
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2
8
55.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SMS-based Mobile Health intervention
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
440 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A Cluster Randomized Trial (CRT) with parallel design will be employed.A Cluster Randomized Trial (CRT) with parallel design will be employed.
Masking:
Single (Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Other
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)
Anticipated Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2020
Anticipated Study Completion Date :
Mar 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: SMS group

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

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

No Intervention: Control group

Standard care of TB treatment with directly observed therapy alone

Outcome Measures

Primary Outcome Measures

  1. Nutritional status change [Change from baseline BMI at end of 2 months and 6 months treatment]

    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.

Secondary Outcome Measures

  1. Dietary practice change [Change from baseline dietary practice at end of 6 months treatment]

    Patient's dietary diversity practice will be assessed through a standardized tool adapted from FANTA Household Dietary Diversity Score

  2. Treatment outcome [End of six months TB treatment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Addis Ababa Health Bureau Addis Ababa Ethiopia

Sponsors and Collaborators

  • Addis Ababa University
  • Fogarty International Center of the National Institute of Health

Investigators

  • Study Chair: Damen Haile Mariam, Addis Ababa University School of Public Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zekariyas Sahile, PhD candidate, Addis Ababa University
ClinicalTrials.gov Identifier:
NCT04242472
Other Study ID Numbers:
  • TB-MeNu
  • D43TW009127
First Posted:
Jan 27, 2020
Last Update Posted:
Jan 27, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zekariyas Sahile, PhD candidate, Addis Ababa University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2020