Study Results
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View full resultsBasic Information
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COMPLETED
NA
392 participants
INTERVENTIONAL
2014-03-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intervention arm
The intervention includes the following components: self-administered drug intake strategy, TB knowledge and socio-psychological counseling session, SMS text messages, phone calls, educational leaflet
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
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.
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
Control arm
patients included in the control arm will receive traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO
No interventions assigned to this group
Interventions
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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
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.
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
Eligibility Criteria
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Inclusion Criteria
* Age 18 years old and above
* Understanding and reading in Armenian
* Completion of the intensive treatment phase
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Grand Challenges Canada
OTHER
National Tuberculosis Control Center, Ministry of Health, Republic of Armenia
UNKNOWN
Varduhi Petrosyan
OTHER
Responsible Party
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Varduhi Petrosyan
MS, PHD
Principal Investigators
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Varduhi Petrosyan, MS, PHD
Role: PRINCIPAL_INVESTIGATOR
American University of Armenia Fund
Locations
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School of Public Health, American University of Armenia Fund
Yerevan, , Armenia
Countries
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References
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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. doi: 10.1016/S0140-6736(06)68380-3.
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
Volmink J, Garner P. Directly observed therapy for treating tuberculosis. Cochrane Database Syst Rev. 2001;(4):CD003343. doi: 10.1002/14651858.CD003343.
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
Khachadourian V, Truzyan N, Harutyunyan A, Petrosyan V, Davtyan H, Davtyan K, van den Boom M, Thompson ME. People-centred care versus clinic-based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial. BMC Pulm Med. 2020 Apr 25;20(1):105. doi: 10.1186/s12890-020-1141-y.
Khachadourian V, Truzyan N, Harutyunyan A, Thompson ME, Harutyunyan T, Petrosyan V. People-centered tuberculosis care versus standard directly observed therapy: study protocol for a cluster randomized controlled trial. Trials. 2015 Jun 22;16:281. doi: 10.1186/s13063-015-0802-2.
Other Identifiers
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S5 0399-01_GCC
Identifier Type: -
Identifier Source: org_study_id
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