Innovative Approach in Tuberculosis Care in Armenia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02082340
• Date of registration: 04/03/2014
• Prospective Registration: No
• Primary sponsor: Varduhi Petrosyan
• Public title: Innovative Approach in Tuberculosis Care in Armenia
• Scientific title: Innovative Approach in Tuberculosis Care in Armenia
• Date of first enrolment: March 2014
• Target sample size: 392
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02082340
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Armenia

Contacts

• Name: Varduhi Petrosyan, MS, PHD
• Affiliation: American University of Armenia Fund

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Other: phone calls

Behavioral: Educational leaflet

Other: SMS text messages

Behavioral: Self-administered drug intake strategy

Behavioral: TB knowledge and socio-psychological counseling session

Primary Outcome(s)

TB Treatment Success Rates Defined by the World Health Organization (WHO) [Time Frame: Patients were followed for the duration of ambulatory phase of treatment, an average of 4.2 months]

Secondary Outcome(s)

Quality of Life of TB Patients [Time Frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)]

Stigma Level Towards TB Patients [Time Frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)]

Depression Status of TB Patients [Time Frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)]

TB Treatment Adherence [Time Frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)]

Family Support Towards TB Patients [Time Frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)]

Knowledge About TB Infection [Time Frame: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)]

Secondary ID(s)

S5 0399-01_GCC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Tuberculosis Control Center, Ministry of Health, Republic of Armenia

Grand Challenges Canada

Results

• Results available: Yes
• Date Posted: 18/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02082340