Skip to main content
OpenTrials
Completed

NCT Number: NCT02082340

Innovative Approach in Tuberculosis Care in Armenia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Behavior Directly Observed Therapy Gram-Positive Bacterial Infections Health Behavior Infections Medication Adherence Mycobacterium Infections Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Public Health, American University of Armenia Fund

Yerevan, 0019, Armenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TB knowledge and socio-psychological counseling session

Behavioral

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

Other

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

Other

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

Behavioral

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

Behavioral

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

Primary outcomes

  1. 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

    The sum of cured (TB patients with bacteriologically confirmed TB at the beginning of treatment who were smear- or culture-negative in the last month of treatment and on at least one previous occasion) and treatment completed (TB patients who completed treatment without evidence of failure but with no record to show that sputum smear or culture results in the last month of treatment and on at least one previous occasion were negative,either because tests were not done or because results are unavailable).

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Varduhi Petrosyan

Other

Collaborators

  • Grand Challenges Canada
  • National Tuberculosis Control Center, Ministry of Health, Republic of Armenia

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 10, 2014
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.