TuberculosisTuberculosisNCT05202431
The Effect of Telephone Follow-up and Training on Treatment Adherence in Tuberculosis Patients and Contacts
A study testing Treatment adherence in people with Tuberculosis, run by Tuberculosis Network European Trialsgroup at 1 site in Turkey (Türkiye).
Trial summary
Tuberculosis (TB) is a preventable and curable disease mostly affecting lungs and caused by the bacteria called as Mycobacterium Tuberculosis (MTB). It is estimated that approximately 10 million people are diagnosed with TB every year in the world and 1.7 billion people are infected by MTB and at risk in terms of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Treatment adherence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 30 Jul 2019
- 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
- With pulmonary TB
- Being voluntary to participate in the study
- Being at and over the age of 18
- Having no communication problems
- Being able to use mobile telephone
Who cannot join
- Being under 18 years old
- Not voluntary to participate in the study
- Having multi drug resistance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Telephone Follow-up and Training on Treatment Adherence in Tuberculosis Patients and Contacts: A Randomised, Controlled and Quasi Experimental Study
Tuberculosis (TB) is a preventable and curable disease mostly affecting lungs and caused by the bacteria called as Mycobacterium Tuberculosis (MTB). It is estimated that approximately 10 million people are diagnosed with TB every year in the world and 1.7 billion people are infected by MTB and at risk in terms of the development of the disease. Contacted person is the one who shares the same environment with the patient suffering from contagious TB and is exposed to MTB bacilli.
Today, the aim of the TB control and prevention programs is to determine the active TB patients and provide cure by healing and also to screen those contacted with the TB patients and determine whether or not they have latent TB infection and treat them and to detect the active cases among the contacts. In the current guidelines, the importance of screening all the contacts of the patients with pulmonary TB and applying a protective treatment for the household in terms of community health care is emphasised. For this reason, it is of prime importance to perform contact screening of the relatives of the TB patients and apply protective treatment. The patients receiving TB and TB protection treatment need to use medicine regularly for at least six months. It is highly important to adherence this period for the success of the treatment. However, it has been reported in the literature that the rate of nonadherence to the TB treatment varies between 20-80% and the nonadherence to the TB treatment is the most serious barrier in the control of the disease. İncomplete treatment may result in long-lasting infection, drug resistance, relapse, and death.
Read more
In the litareture, it has been stated in the study conducted with the individuals with some chronic diseases that tele-follow-up is effective in providing the self-care agency of patients and the cognitive-social adaptation. It has been reported that some problems emerge especially in the TB patients such as the interruption of treatment, forgetting medication (24.5%), side-effects of drugs, (23.3%), symptomatic recovery (19.5%), failure to know the necessity of completing the life cycle of drugs by most of patients and not receiving adequate training and these problems may be managed more effectively by tele-follow-up.
As is known, nurses are involved in all the processes of protecting-promoting the health of the individuals, families and society and their recovery in case of disease. Moreover, providing the protective treatment by performing the required screening for treating TB patients, their follow-up and preventing the development of disease in contacted ones has a vital importance in preventing the spread of TB in the society. Nurses may follow the findings of patients, obtain information about the process, produce information and transmit information with this system (reporting drug changes, performing training follow-up of patients etc.). In the literature, it has been emphasised that tele-mobile nursing services is a cost-effective method since it decreases the hospitalisation rate and period of the TB patients. Accordingly, the main aim of this study is to assess the effect of the training and the telephone follow-up provided by the nurse for the TB patients and contacts on the medication adherence.
Read the detailed description
This research was conducted as a randomised, controlled and quasi-experimental study to determine the effect of the training and telephone follow-up provided to the TB patients and contacts on the treatment adherence. The population of the study was composed of the patients receiving treatment in a tuberculosis control dispensary between July 2018-July 2019. The sample size was calculated to be 28 in each group through power analysis. Eighty-one TB patients and 90 TB contacts were included in the study. However, 15 TB patients and 3 contacts were excluded since they were transferred to another dispensary and they died. The study was completed with 66 TB patients in the intervention (n= 32) and control groups (n=34) and 87 contacts in the intervention (n= 41) and control groups (n = 46) The TB patients who applied to the dispensary and their contacts were informed about the aim and scope of the study. Then, four groups were formed by using the randomisation menu of the computer program: the intervention and control groups for the TB patients and the intervention and control groups for the contacts. The randomisation was conducted by a statistics specialist who had no contact with the participants. All participants were blinded to the randomisation procedure. However, the researchers were not blinded to the patient groups, due to the nature of the intervention.
The interviews were performed by using the face-to-face interview technique in the outpatient clinic. In the first interview, the questionnaire was applied to four groups; TB intervention and TB control group, Contact intervention and Contact control group.
- Conditions
- Tuberculosis
- Being tested
- Treatment adherence
- Keywords
- nursing education, tuberculosis, tuberculosis contact, treatment adherence, telephonefollow-up
- Medical subject headings
- Tuberculosis, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment adherenceBehavioural
The patients were reminded to take drug by patient training, telephone follow-up, and daily sms. It was determined that the effect of the training and telephone follow-up provided to the TB patients and contacts on the treatment adherence.
| Study group | Role | What they receive |
|---|---|---|
| Adherence | Experimental | Participants received training, telefollow-up and daily text messages for 6 months. Receives: Behavioral: Treatment adherence |
| Standart care | No intervention | The standard follow-up applied in the dispensary for this group was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in treatment adherence during the Follow-up
Tuberculosis Adherence Determination Questionnaire (TADQ) was conducted. It is a 5-point likert scale and minimum and maximum scores of the scale are 26 and 175 and high score signifies that adherence increases.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Jul 2018
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuberculosis Network European Trialsgroup
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Sema Aytaç, PhD, Tuberculosis Network European Trialsgroup
- Investigators
- Sema Aytac, Principal investigator, Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202431
- Sponsor's protocol ID
- TBNET
- Acronym
- Tuberculosis
- Status last verified
- Jan 2022
- First submitted
- 14 Dec 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aytac S, Ovayolu O, Dogru S. The effect of breathing exercises on fatigue in tuberculosis patients: a randomized controlled trial. Rev Assoc Med Bras (1992). 2024 Dec 2;70(12):e20240888. doi: 10.1590/1806-9282.20240888. eCollection 2024.
PubMed 39630726
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telephone Follow-up and Training on Treatment Adherence in Tuberculosis Patients and Contacts: A Randomised, Controlled and Quasi Experimental Study
- ClinicalTrials.gov ID
- NCT05202431
- Acronym / sponsor ID
- Tuberculosis / TBNET
- Conditions
- Tuberculosis
- Keywords
- nursing education, tuberculosis, tuberculosis contact, treatment adherence, telephonefollow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Tuberculosis Network European TrialsgroupResearch network
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 21 Jan 2022 (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.
Tuberculosis (TB) is a preventable and curable disease mostly affecting lungs and caused by the bacteria called as Mycobacterium Tuberculosis (MTB). It is estimated that approximately 10 million people are diagnosed with TB every year in the world and 1.7 billion people are infected by MTB and at risk in terms of the development of the disease. Contacted person is the one who shares the same environment with the patient suffering from contagious TB and is exposed to MTB bacilli.
Today, the aim of the TB control and prevention programs is to determine the active TB patients and provide cure by healing and also to screen those contacted with the TB patients and determine whether or not they have latent TB infection and treat them and to detect the active cases among the contacts. In the current guidelines, the importance of screening all the contacts of the patients with pulmonary TB and applying a protective treatment for the household in terms of community health care is emphasised. For this reason, it is of prime importance to perform contact screening of the relatives of the TB patients and apply protective treatment. The patients receiving TB and TB protection treatment need to use medicine regularly for at least six months. It is highly important to adherence this period for the success of the treatment. However, it has been reported in the literature that the rate of nonadherence to the TB treatment varies between 20-80% and the nonadherence to the TB treatment is the most serious barrier in the control of the disease. İncomplete treatment may result in long-lasting infection, drug resistance, relapse, and death.
In the litareture, it has been stated in the study conducted with the individuals with some chronic diseases that tele-follow-up is effective in providing the self-care agency of patients and the cognitive-social adaptation. It has been reported that some problems emerge especially in the TB patients such as the interruption of treatment, forgetting medication (24.5%), side-effects of drugs, (23.3%), symptomatic recovery (19.5%), failure to know the necessity of completing the life cycle of drugs by most of patients and not receiving adequate training and these problems may be managed more effectively by tele-follow-up.
As is known, nurses are involved in all the processes of protecting-promoting the health of the individuals, families and society and their recovery in case of disease. Moreover, providing the protective treatment by performing the required screening for treating TB patients, their follow-up and preventing the development of disease in contacted ones has a vital importance in preventing the spread of TB in the society. Nurses may follow the findings of patients, obtain information about the process, produce information and transmit information with this system (reporting drug changes, performing training follow-up of patients etc.). In the literature, it has been emphasised that tele-mobile nursing services is a cost-effective method since it decreases the hospitalisation rate and period of the TB patients. Accordingly, the main aim of this study is to assess the effect of the training and the telephone follow-up provided by the nurse for the TB patients and contacts on the medication adherence.
Detailed description
This research was conducted as a randomised, controlled and quasi-experimental study to determine the effect of the training and telephone follow-up provided to the TB patients and contacts on the treatment adherence. The population of the study was composed of the patients receiving treatment in a tuberculosis control dispensary between July 2018-July 2019. The sample size was calculated to be 28 in each group through power analysis. Eighty-one TB patients and 90 TB contacts were included in the study. However, 15 TB patients and 3 contacts were excluded since they were transferred to another dispensary and they died. The study was completed with 66 TB patients in the intervention (n= 32) and control groups (n=34) and 87 contacts in the intervention (n= 41) and control groups (n = 46) The TB patients who applied to the dispensary and their contacts were informed about the aim and scope of the study. Then, four groups were formed by using the randomisation menu of the computer program: the intervention and control groups for the TB patients and the intervention and control groups for the contacts. The randomisation was conducted by a statistics specialist who had no contact with the participants. All participants were blinded to the randomisation procedure. However, the researchers were not blinded to the patient groups, due to the nature of the intervention.
The interviews were performed by using the face-to-face interview technique in the outpatient clinic. In the first interview, the questionnaire was applied to four groups; TB intervention and TB control group, Contact intervention and Contact control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adherence | Experimental | Behavioral: Treatment adherenceParticipants received training, telefollow-up and daily text messages for 6 months. |
| Standart care | No intervention | –The standard follow-up applied in the dispensary for this group was performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- With pulmonary TB
- Being voluntary to participate in the study
- Being at and over the age of 18
- Having no communication problems
- Being able to use mobile telephone
Key exclusion criteria (3 listed)
- Being under 18 years old
- Not voluntary to participate in the study
- Having multi drug resistance
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 |
|---|---|---|
| Treatment adherenceThe patients were reminded to take drug by patient training, telephone follow-up, and daily sms. It was determined that the effect of the training and telephone follow-up provided to the TB patients and contacts on the treatment adherence. | Behavioural | Adherence |
Primary outcome
Change in treatment adherence during the Follow-up
Time frame: 6 months
Tuberculosis Adherence Determination Questionnaire (TADQ) was conducted. It is a 5-point likert scale and minimum and maximum scores of the scale are 26 and 175 and high score signifies that adherence increases.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Derived from this study: PubMed 39630726Aytac S, Ovayolu O, Dogru S. The effect of breathing exercises on fatigue in tuberculosis patients: a randomized controlled trial. Rev Assoc Med Bras (1992). 2024 Dec 2;70(12):e20240888. doi: 10.1590/1806-9282.20240888. eCollection 2024.
- 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.
Sema Aytac principal investigator
Gaziantep
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment adherence in people with Tuberculosis, run by Tuberculosis Network European Trialsgroup at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 21 Jan 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in treatment adherence during the Follow-up (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05202431, which also lists 1 linked publication.
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 21 Jan 2022.