Trial reportTrials2015
People-centered tuberculosis care versus standard directly observed therapy: study protocol for a cluster randomized controlled trial.
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02082340 (Innovative Approach in Tuberculosis Care in Armenia), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Innovative Approach in Tuberculosis Care in Armenia
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Toward Developing a Standardized Core Set of Outcome Measures in Mobile Health Interventions for Tuberculosis Management: Systematic Review.JMIR mHealth and uHealth · 2019Pooled it
- Educational Level Mediates the Relationship Between Knowledge and Preventive Practices in Multidrug-Resistant Tuberculosis Patients.Epidemiologia (Basel, Switzerland) · 2025Article
- Technology-integrated nursing interventions to improve adherence to tuberculosis medication: a scoping review.BMC nursing · 2025Article
- Empowering Capabilities of People With Chronic Conditions Supported by Digital Health Technologies: Scoping Review.Journal of medical Internet research · 2025Article
- Development and assessment of novel machine learning models to predict medication non-adherence risks in type 2 diabetics.Frontiers in public health · 2022Article
- Preparedness of outpatient health facilities for ambulatory treatment with all-oral short DR-TB treatment regimens in Zhytomyr, Ukraine: a cross-sectional study.BMC health services research · 2020Article
- People-centred care versus clinic-based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial.BMC pulmonary medicine · 2020Article
- Article
- To End TB, First-Ever High-Level Meeting on Tuberculosis Must Address Stigma.The American journal of tropical medicine and hygiene · 2018Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTuberculosis is a major public health concern resulting in high rates of morbidity and mortality worldwide, particularly in low- and middle-income countries. Tuberculosis requires a long and intensive course of treatment. Thus, various approaches, including patient empowerment, education and counselling sessions, and involvement of family members and community workers, have been suggested for improving treatment adherence and outcome. The current randomized controlled trial aims to evaluate the effectiveness over usual care of an innovative multicomponent people-centered tuberculosis-care strategy in Armenia. METHODS/
designInnovative Approach to Tuberculosis care in Armenia is an open-label, stratified cluster randomized controlled trial with two parallel arms. Tuberculosis outpatient centers are the clusters assigned to intervention and control arms. Drug-sensitive tuberculosis patients in the continuation phase of treatment in the intervention arm and their family members participate in a short educational and counselling session to raise their knowledge, decrease tuberculosis-related stigma, and enhance treatment adherence. Patients receive the required medications for one week during the weekly visits to the tuberculosis outpatient centers. Additionally, patients receive daily Short Message Service (SMS) reminders to take their medications and daily phone calls to assure adherence and monitoring of treatment potential side effects. Control-arm patients follow the World Health Organization--recommended directly observed treatment strategy, including daily visits to tuberculosis outpatient centers for drug-intake. The primary outcome is physician-reported treatment outcome. Patients' knowledge, depression, quality of life, within-family tuberculosis-related stigma, family social support, and self-reported adherence to tuberculosis treatment are secondary outcomes. DISCUSSION: Improved adherence and tuberculosis treatment outcomes can strengthen tuberculosis control and thereby forestall tuberculosis and multidrug resistant tuberculosis epidemics. Positive findings on effectiveness of this innovative tuberculosis treatment people-centered approach will support its adoption in countries with similar healthcare and economic profiles.
trial registrationClinicalTrials.gov registration number: NCT02082340. Date of registration: 4 March 2014.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.