CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 392 enrolled
Drug / intervention
TB knowledge and socio-psychological counseling session +4 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02082340
NCT02082340N/ACompleted

Innovative Approach in Tuberculosis Care in Armenia

Varduhi Petrosyan·interventional·Posted Mar 10, 2014·Updated Feb 18, 2020

In Brief

A clinical study evaluating TB knowledge and socio-psychological counseling session, SMS text messages, and 3 other interventions for Tuberculosis. Completed, enrolled 392 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesArmenia

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 10, 2014
Enrollment StartMar 1, 2014
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.3 years ago

Interventions

TB knowledge and socio-psychological counseling sessionbehavioral

TB patients and their family members will participate in one-day counseling session provided by a trained psychologist and a TB nurse

SMS text messagesother

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 callsother

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 strategybehavioral

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 leafletbehavioral

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