Innovative Approach in Tuberculosis Care in Armenia

NCT02082340 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2020-02-18

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Grand Challenges Canada

    collaborator OTHER
  • National Tuberculosis Control Center, Ministry of Health, Republic of Armenia

    collaborator UNKNOWN
  • Varduhi Petrosyan

    lead OTHER

Principal Investigators

  • Varduhi Petrosyan, MS, PHD · American University of Armenia Fund

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Armenia

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02082340 on ClinicalTrials.gov