NCT05202431

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

December 14, 2021

Last Update Submit

January 20, 2022

Conditions

Keywords

nursing educationtuberculosistuberculosis contacttreatment adherencetelephonefollow-up

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (2)

Adherence

EXPERIMENTAL

Participants received training, telefollow-up and daily text messages for 6 months.

Behavioral: Treatment adherence

Standart care

NO INTERVENTION

The standard follow-up applied in the dispensary for this group was performed.

Interventions

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.

Adherence

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Being under 18 years old
  • Not voluntary to participate in the study
  • Having multi drug resistance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

TuberculosisTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsHealth BehaviorBehavior

Study Officials

  • Sema Aytac

    Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 21, 2022

Study Start

July 1, 2018

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

January 21, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations