TuberculosisNCT04242472
SMS-based Mobile Health Intervention for Nutritional Status and Treatment Outcome Among TB Patients
A study testing SMS-based Mobile Health intervention in people with Tuberculosis and Undernutrition, run by Addis Ababa University at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Undernutrition
- What is being tested?
- SMS-based Mobile Health intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 1 siteEthiopia
- Study dates
- Jul 2020to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patient whose TB treatment regimen more than 6 months
- Patient who is pregnant and lactating mothers
- Patient who enrolled other Interventional research
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Addis Ababa Health Bureau
Addis Ababa
Yohannes Dr, 911384599 ext. +251, yoha2wok@yahoo.com
Zekariyas Sa Nezenega, MPH
About this study
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)
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.
Read the 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
- Being tested
- SMS-based Mobile Health intervention
- Keywords
- Tuberculosis, Nutrition, Treatment outcome, SMS
- Medical subject headings
- Tuberculosis, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS-based Mobile Health interventionBehavioural
Nutritional related SMS text message mobile health intervention will be provided to Tuberculosis patients.
| Study group | Role | What they receive |
|---|---|---|
| SMS group | Experimental | Nutrition-related SMS messages in addition to standard of care TB treatment with directly observed therapy Receives: Behavioral: SMS-based Mobile Health intervention |
| Control group | No intervention | Standard care of TB treatment with directly observed therapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline BMI at end of 2 months and 6 months treatment
Secondary outcomes (2)
Dietary practice change
Patient's dietary diversity practice will be assessed through a standardized tool adapted from FANTA Household Dietary Diversity Score
Measured: 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.
Measured: End of six months TB treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study startJul 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Cluster Randomized Trial (CRT) with parallel design will be employed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Addis Ababa University
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Zekariyas Sahile, Addis Ababa University
- Investigators
- Damen Haile Mariam, Study chair, Addis Ababa University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242472
- Sponsor's protocol ID
- TB-MeNu
- Other IDs
- D43TW009127
- Status last verified
- Jan 2020
- First submitted
- 20 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04242472
- Acronym / sponsor ID
- TB-MeNu
- Conditions
- Tuberculosis, Undernutrition
- Keywords
- Tuberculosis, Nutrition, Treatment outcome, SMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Addis Ababa UniversityUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- Jul 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A Cluster Randomized Trial (CRT) with parallel design will be employed.
| Arm | Type | Receives |
|---|---|---|
| SMS group | Experimental | Behavioral: SMS-based Mobile Health interventionNutrition-related SMS messages in addition to standard of care TB treatment with directly observed therapy |
| Control group | No intervention | –Standard care of TB treatment with directly observed therapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Patient whose TB treatment regimen more than 6 months
- Patient who is pregnant and lactating mothers
- Patient who enrolled other Interventional research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS-based Mobile Health interventionNutritional related SMS text message mobile health intervention will be provided to Tuberculosis patients. | Behavioural | SMS group |
Primary outcome
Nutritional status change
Time frame: 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.
2 secondary outcomes
Dietary practice change
Time frame: Change from baseline dietary practice at end of 6 months treatment
Treatment outcome
Time frame: End of six months TB treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damen Haile Mariam study chair
Addis Ababa University School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS-based Mobile Health intervention in people with Tuberculosis and Undernutrition, run by Addis Ababa University at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zekariyas Sa Nezenega (911072963 ext. +251, zekitiru@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status change (time frame: Change from baseline BMI at end of 2 months and 6 months treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.