TuberculosisNCT02082340
Innovative Approach in Tuberculosis Care in Armenia
A study testing TB knowledge and socio-psychological counseling session, SMS text messages and phone calls in people with Tuberculosis, run by Varduhi Petrosyan at 1 site in Armenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- TB knowledge and socio-psychological counseling session, SMS text messages and phone calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteArmenia
- Study dates
- Mar 2014to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of drug-sensitive TB
- Age 18 years old and above
- Understanding and reading in Armenian
- Completion of the intensive treatment phase
Who cannot join
- Involvement in the Home Based TB Treatment Program of the National TB Control Office
Trial locations and contacts
1 site in 1 country.
Armenia1 site
School of Public Health, American University of Armenia Fund
Yerevan, 0019
About this study
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.
Read the 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.
- Conditions
- Tuberculosis
- Being tested
- TB knowledge and socio-psychological counseling session, SMS text messages, phone calls, Self-administered drug intake strategy, Educational leaflet
- Keywords
- Tuberculosis, Armenia, Clinical trial, Directly Observed Therapy (DOT), Self-administered drug intake
- Medical subject headings
- Tuberculosis, Directly Observed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TB knowledge and socio-psychological counseling sessionBehavioural
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 strategyBehavioural
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 leafletBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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 Receives: Behavioral: TB knowledge and socio-psychological counseling session; Other: SMS text messages; Other: phone calls; Behavioral: Self-administered drug intake strategy; Behavioral: Educational leaflet |
| Control arm | No intervention | patients included in the control arm will receive traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
TB Treatment Success Rates Defined by the World Health Organization (WHO)
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).
Measured: Patients were followed for the duration of ambulatory phase of treatment, an average of 4.2 months
Secondary outcomes (6)
Knowledge About TB Infection
Knowledge about TB infection will be measured by surveys
Measured: 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
Stigma level towards TB patients will be measured by surveys
Measured: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Family Support Towards TB Patients
Change in family support towards TB patients will be measured by surveys
Measured: 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
TB treatment adherence will be measured by surveys
Measured: 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
Depression status of TB patients will be measured by surveys
Measured: 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
Quality of life of TB patients will be measured by surveys
Measured: At baseline and upon completion of the treatment (an expected average of 4.5 months after starting the ambulatory phase of the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Varduhi Petrosyan
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, National Tuberculosis Control Center, Ministry of Health, Republic of Armenia
- Responsible party
- Sponsor-investigator, Varduhi Petrosyan, American University of Armenia Fund
- Investigators
- Varduhi Petrosyan, MS, PHD, Principal investigator, American University of Armenia Fund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082340
- Sponsor's protocol ID
- S5 0399-01_GCC
- Status last verified
- Feb 2020
- First submitted
- 4 Mar 2014
- Last updated
- 18 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Newell JN, Baral SC, Pande SB, Bam DS, Malla P. Family-member DOTS and community DOTS for tuberculosis control in Nepal: cluster-randomised controlled trial. Lancet. 2006 Mar 18;367(9514):903-9. doi: 10.1016/S0140-6736(06)68380-3.
PubMed 16546538Raza 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
Volmink J, Garner P. Directly observed therapy for treating tuberculosis. Cochrane Database Syst Rev. 2001;(4):CD003343. doi: 10.1002/14651858.CD003343.
PubMed 11687192Truzyan 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
Khachadourian V, Truzyan N, Harutyunyan A, Petrosyan V, Davtyan H, Davtyan K, van den Boom M, Thompson ME. People-centred care versus clinic-based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial. BMC Pulm Med. 2020 Apr 25;20(1):105. doi: 10.1186/s12890-020-1141-y.
PubMed 32334553Khachadourian V, Truzyan N, Harutyunyan A, Thompson ME, Harutyunyan T, Petrosyan V. People-centered tuberculosis care versus standard directly observed therapy: study protocol for a cluster randomized controlled trial. Trials. 2015 Jun 22;16:281. doi: 10.1186/s13063-015-0802-2.
PubMed 26093675
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Approach in Tuberculosis Care in Armenia
- ClinicalTrials.gov ID
- NCT02082340
- Acronym / sponsor ID
- S5 0399-01_GCC
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Armenia, Clinical trial, Directly Observed Therapy (DOT), Self-administered drug intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Varduhi PetrosyanUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, National Tuberculosis Control Center, Ministry of Health, Republic of Armenia
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Mar 2014 (estimated)
- Results
- Posted 18 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: TB knowledge and socio-psychological counseling session, Other: SMS text messages, Other: phone calls, Behavioral: Self-administered drug intake strategy, Behavioral: Educational leafletThe intervention includes the following components: self-administered drug intake strategy, TB knowledge and socio-psychological counseling session, SMS text messages, phone calls, educational leaflet |
| Control arm | No intervention | –patients included in the control arm will receive traditional - clinical Directly Observed Therapy (DOT) as recommended by WHO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of drug-sensitive TB
- Age 18 years old and above
- Understanding and reading in Armenian
- Completion of the intensive treatment phase
Key exclusion criteria (1 listed)
- Involvement in the Home Based TB Treatment Program of the National TB Control Office
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TB knowledge and socio-psychological counseling sessionTB patients and their family members will participate in one-day counseling session provided by a trained psychologist and a TB nurse | Behavioural | Intervention arm |
| SMS text messagesTB 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 | Intervention arm |
| phone callsFamily 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. | Other | Intervention arm |
| Self-administered drug intake strategyOnce 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. | Behavioural | Intervention arm |
| Educational leafletEducational 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 | Behavioural | Intervention arm |
Primary outcome
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).
6 secondary outcomes
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)
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16546538Newell JN, Baral SC, Pande SB, Bam DS, Malla P. Family-member DOTS and community DOTS for tuberculosis control in Nepal: cluster-randomised controlled trial. Lancet. 2006 Mar 18;367(9514):903-9. doi: 10.1016/S0140-6736(06)68380-3.
- BackgroundRaza 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
- Background: PubMed 11687192Volmink J, Garner P. Directly observed therapy for treating tuberculosis. Cochrane Database Syst Rev. 2001;(4):CD003343. doi: 10.1002/14651858.CD003343.
- BackgroundTruzyan 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
- Derived from this study: PubMed 32334553Khachadourian V, Truzyan N, Harutyunyan A, Petrosyan V, Davtyan H, Davtyan K, van den Boom M, Thompson ME. People-centred care versus clinic-based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial. BMC Pulm Med. 2020 Apr 25;20(1):105. doi: 10.1186/s12890-020-1141-y.
- Derived from this study: PubMed 26093675Khachadourian V, Truzyan N, Harutyunyan A, Thompson ME, Harutyunyan T, Petrosyan V. People-centered tuberculosis care versus standard directly observed therapy: study protocol for a cluster randomized controlled trial. Trials. 2015 Jun 22;16:281. doi: 10.1186/s13063-015-0802-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Varduhi Petrosyan, MS, PHD principal investigator
American University of Armenia Fund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TB knowledge and socio-psychological counseling session, SMS text messages and phone calls in people with Tuberculosis, run by Varduhi Petrosyan at 1 site in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02082340, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.