Innovative Approach in Tuberculosis Care in Armenia

Tuberculosis Clinical Trial

Official title:

Innovative Approach in Tuberculosis Care in Armenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082340
• Other study ID #: S5 0399-01_GCC
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: May 2015

Study information

• Verified date: February 2020
• Source: American University of Armenia Fund
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized trial tests effectiveness of self-administered drug intake by empowered TB patients - supervised by a trained family member and supported by medical counseling and reminders - to improve treatment adherence and treatment success rates, and thereby forestall TB and MDR-TB epidemics.

Description:

The innovative treatment approach integrates several educational, technological, and social evidence-based components. The aim of this study is to pilot the innovative approach for drug-sensitive TB patients during the outpatient phase of tuberculosis treatment. To test the effectiveness of the innovative approach (intervention) a randomized controlled trial with two arms will be conducted. The intervention arm will include drug-sensitive tuberculosis patients that are treated according to the innovative approach, which includes self-administered drug intake supervised by a family member, TB patient and family member training (including distribution of a leaflet about TB) and psychological counseling, reminder text messages to TB patients, and reminder phone call to TB patient family members. The control arm will include drug-sensitive tuberculosis patients that receive the regular Directly Observed Therapy recommended by the World Health Organization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of drug-sensitive TB

• Age 18 years old and above

• Understanding and reading in Armenian

• Completion of the intensive treatment phase

Exclusion Criteria:

• Involvement in the Home Based TB Treatment Program of the National TB Control Office

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Behavioral:
• TB knowledge and socio-psychological counseling session
TB patients and their family members will participate in one-day counseling session provided by a trained psychologist and a TB nurse

Other:
• SMS text messages
TB patients will receive SMS text messages every morning (except Sunday) during the whole ambulatory TB treatment phase as a reminder for taking the TB medication prescribed and provided by the TB physician
• phone calls
Family members of the TB patients will receive phone calls every evening (except Sunday) during the whole ambulatory TB treatment phase to assure that the patient takes the medication prescribed and provided by the TB physician and to collect information on treatment adherence and possible side effects.

Behavioral:
• Self-administered drug intake strategy
Once a week TB patients will receive the TB medication from their local outpatient TB centers and will use the medication every day (six days a week, except Sunday according to the TB treatment protocol) at home under supervision of a family member in charge.
• Educational leaflet
Educational leaflet containing information on TB infection; infection control measures; importance of TB treatment adherence and family support will be provided to all TB patients at the end of the counselling session

Locations

Country	Name	City	State
Armenia	School of Public Health, American University of Armenia Fund	Yerevan

Sponsors (3)

Lead Sponsor	Collaborator
Varduhi Petrosyan	Grand Challenges Canada, National Tuberculosis Control Center, Ministry of Health, Republic of Armenia

Country where clinical trial is conducted

Armenia, 

References & Publications (4)

Newell JN, Baral SC, Pande SB, Bam DS, Malla P. Family-member DOTS and community DOTS for tuberculosis control in Nepal: cluster-randomised controlled trial. Lancet. 2006 Mar 18;367(9514):903-9. — View Citation

Raza S, Sarfaraz M, Ahmad M. Practice of family and non-family based directly observed treatment for tuberculosis in Pakistan: A retrospective cohort study. The Health 2012; 3(2): 39-44

Truzyan N, Harutyunyan T, Koshkakaryan M, Petrosyan V. Household TB Infection Control Pilot Project: Counseling for TB Patients and Their Family Members. American University of Armenia School of Public Health, Center for Health Services Research and Development, Yerevan, Armenia, 2013

Volmink J, Garner P. Directly observed therapy for treating tuberculosis. Cochrane Database Syst Rev. 2003;(1):CD003343. Review. Update in: Cochrane Database Syst Rev. 2006;(2):CD003343. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TB Treatment Success Rates Defined by the World Health Organization (WHO)	The sum of cured (TB patients with bacteriologically confirmed TB at the beginning of treatment who were smear- or culture-negative in the last month of treatment and on at least one previous occasion) and treatment completed (TB patients who completed treatment without evidence of failure but with no record to show that sputum smear or culture results in the last month of treatment and on at least one previous occasion were negative,either because tests were not done or because results are unavailable).	Patients were followed for the duration of ambulatory phase of treatment, an average of 4.2 months
Secondary	Knowledge About TB Infection	Knowledge about TB infection will be measured by surveys	At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Secondary	Stigma Level Towards TB Patients	Stigma level towards TB patients will be measured by surveys	At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Secondary	Family Support Towards TB Patients	Change in family support towards TB patients will be measured by surveys	At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Secondary	TB Treatment Adherence	TB treatment adherence will be measured by surveys	At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Secondary	Depression Status of TB Patients	Depression status of TB patients will be measured by surveys	At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Secondary	Quality of Life of TB Patients	Quality of life of TB patients will be measured by surveys	At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)