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Innovative Approach in Tuberculosis Care in Armenia

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ClinicalTrials.gov Identifier: NCT02082340
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : June 30, 2015
Sponsor:
Collaborators:
Grand Challenges Canada
National Tuberculosis Control Center, Ministry of Health, Republic of Armenia
Information provided by (Responsible Party):
Varduhi Petrosyan, American University of Armenia Fund

Brief 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.

Condition or disease Intervention/treatment Phase
Tuberculosis Behavioral: TB knowledge and socio-psychological counseling session Other: SMS text messages Other: phone calls Behavioral: Self-administered drug intake strategy Behavioral: Educational leaflet Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 395 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Innovative Approach in Tuberculosis Care in Armenia
Study Start Date : March 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Experimental: 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
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

Other: 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.

Behavioral: 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

No Intervention: Control arm
patients included in the control arm will receive traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO



Primary Outcome Measures :
  1. TB treatment success rates defined by the WHO [ Time Frame: Patients will be followed for the duration of ambulatory phase of treatment, an expected average of 4.5 months ]

Secondary Outcome Measures :
  1. 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) ]
    Knowledge about TB infection will be measured by surveys

  2. 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) ]
    Stigma level towards TB patients will be measured by surveys

  3. 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) ]
    Change in family support towards TB patients will be measured by surveys

  4. 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) ]
    TB treatment adherence will be measured by surveys

  5. 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) ]
    Depression status of TB patients will be measured by surveys

  6. 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) ]
    Quality of life of TB patients will be measured by surveys



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082340


Locations
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Armenia
School of Public Health, American University of Armenia Fund
Yerevan, Armenia, 0019
Sponsors and Collaborators
Varduhi Petrosyan
Grand Challenges Canada
National Tuberculosis Control Center, Ministry of Health, Republic of Armenia
Investigators
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Principal Investigator: Varduhi Petrosyan, MS, PHD American University of Armenia Fund

Publications:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Varduhi Petrosyan, MS, PHD, American University of Armenia Fund
ClinicalTrials.gov Identifier: NCT02082340     History of Changes
Other Study ID Numbers: S5 0399-01_GCC
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015

Keywords provided by Varduhi Petrosyan, American University of Armenia Fund:
Tuberculosis
Armenia
Clinical trial
Directly Observed Therapy (DOT)
Self-administered drug intake

Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections