N/A
N=392
Innovative Approach in Tuberculosis Care in Armenia
Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT02082340 ↗Enrolled (actual)
392
Serious AEs
1.5%
Results posted
Feb 2020
Primary outcome: Primary: TB Treatment Success Rates Defined by the World Health Organization (WHO) — 184; 176 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TB knowledge and socio-psychological counseling session (Behavioral); SMS text messages (Other); phone calls (Other); Self-administered drug intake strategy (Behavioral); Educational leaflet (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Varduhi Petrosyan
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TB Treatment Success Rates Defined by the World Health Organization (WHO) |
184; 176 | — |
| SECONDARY Knowledge About TB Infection |
— | — |
| SECONDARY Stigma Level Towards TB Patients |
— | — |
| SECONDARY Family Support Towards TB Patients |
— | — |
| SECONDARY TB Treatment Adherence |
— | — |
| SECONDARY Depression Status of TB Patients |
— | — |
| SECONDARY Quality of Life of TB Patients |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02082340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.