TuberculosisNCT02331732
Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova
A study testing Virtually Observed Treatment and Directly Observed Treatment in people with Tuberculosis, run by The Behavioural Insights Team.
Trial summary
This trial aims to increase the wellbeing of tuberculosis patients and their adherence to medication in Chisinau, The Republic of Moldova. The design is an individually randomised controlled trial (RCT) and will involve 400 TB patients during their 'continuation phase' of treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Virtually Observed Treatment and Directly Observed Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consent to being part of the trial
- Live in Chisinau and no plans to move away from Chisinau during the four months
- Aged 18 or over
- At least four months of care remaining
Who cannot join
- Having MDR-TB
- Homeless
- Is not homeless
- Suffer from alcoholism or drug misuse
- In prison
- Has a treatment regimen with injections
Trial locations and contacts
No sites are listed yet.
About this study
This trial aims to increase the wellbeing of tuberculosis patients and their adherence to medication in Chisinau, The Republic of Moldova. The design is an individually randomised controlled trial (RCT) and will involve 400 TB patients during their 'continuation phase' of treatment. The trial will have two arms; 200 patients will form the control group and receive the standard provision of Directly Observed Treatment (DOT) and 200 will receive Virtually Observed Treatment (VOT).
VOT differs from DOT in that the daily observation of patients taking their medication will be observed via internet video messages rather than in-person. Based on a small sample of patient interviews we think that for some patients DOT may be a hindrance rather than a help. VOT allows patients to take their treatment in the comfort of their home and means they don't have to travel to their polyclinic every day.
There will be a central VOT observation centre where VOT observers will view and respond to video messages sent in by patients in the VOT arm. The messages will be sent via an M-Health app. The VOT observers will also respond to the patients by sending feedback to the patients. The trial duration will depend on the recruitment rate of eligible patients but is expected to take 16 months.
- Conditions
- Tuberculosis
- Being tested
- Virtually Observed Treatment, Directly Observed Treatment
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtually Observed TreatmentBehavioural
Directly Observed TreatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients receive DOT as normal - involves patient going to polyclinic to be observed taking treatment every day Receives: Other: Directly Observed Treatment |
| Treatment | Experimental | Patients receive VOT - involves patient sending a video of themselves taking their treatment over M-health app which will be reviewed remotely by observers Receives: Behavioral: Virtually Observed Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to medication
Number of days per two week period that each patient fails to adhere to treatment, continuous. Panel data collected from TB-01 record sheets for duration of patient continuation phase of treatment - on average 5 months
Measured: 2 weeks
Secondary outcomes (8)
Adherence 80%
Proportion of patients having more than 80% of scheduled medication sessions per two week period (binary). Panel data collected for duration of patient continuation phase of treatment - on average 5 months
Measured: 2 weeks
Patient wellbeing
Self reported using a short form version (5 questions) of the WEMWBS questionnaire for measuring mental wellbeing was developed by researchers at Warwick and Edinburgh Universities
Measured: Collected at 4 months
Patient satisfaction
Binary variable equal to 1 if a patient gives a positive response about their treatment on a likert scale (questionnaire, self-reported)
Measured: Collected at 4 months
Travel and time cost of treatment borne by patient, self reported.
Total travel time and cost over 4 months (derived from questionnaire, self-reported)
Measured: Collected at 4 months
Employment, self reported
Binary variable equal to 1 if patient currently does any work for pay or profit (questionnaire, self-reported)
Measured: Collected at 4 months
Treatment success
Binary variable equal to 1 if treatment recorded a success on TB-01 patient record at 4 months
Measured: Collected at 4 months
Body mass index (BMI)
Body mass index (BMI), measured at 4 months
Measured: Collected at 4 months
Side effects reported during treatment
Binary variable equal to 1 if patient reported any side effects during treatment (questionnaire, self-reported)
Measured: Collected at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Behavioural Insights Team
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331732
- Sponsor's protocol ID
- 201405*
- Status last verified
- Sep 2015
- First submitted
- 13 Dec 2014
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ravenscroft L, Kettle S, Persian R, Ruda S, Severin L, Doltu S, Schenck B, Loewenstein G. Video-observed therapy and medication adherence for tuberculosis patients: randomised controlled trial in Moldova. Eur Respir J. 2020 Aug 6;56(2):2000493. doi: 10.1183/13993003.00493-2020. Print 2020 Aug.
PubMed 32381495
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova
- ClinicalTrials.gov ID
- NCT02331732
- Acronym / sponsor ID
- 201405*
- Conditions
- Tuberculosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The Behavioural Insights TeamUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to increase the wellbeing of tuberculosis patients and their adherence to medication in Chisinau, The Republic of Moldova. The design is an individually randomised controlled trial (RCT) and will involve 400 TB patients during their 'continuation phase' of treatment. The trial will have two arms; 200 patients will form the control group and receive the standard provision of Directly Observed Treatment (DOT) and 200 will receive Virtually Observed Treatment (VOT).
VOT differs from DOT in that the daily observation of patients taking their medication will be observed via internet video messages rather than in-person. Based on a small sample of patient interviews we think that for some patients DOT may be a hindrance rather than a help. VOT allows patients to take their treatment in the comfort of their home and means they don't have to travel to their polyclinic every day.
There will be a central VOT observation centre where VOT observers will view and respond to video messages sent in by patients in the VOT arm. The messages will be sent via an M-Health app. The VOT observers will also respond to the patients by sending feedback to the patients. The trial duration will depend on the recruitment rate of eligible patients but is expected to take 16 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Directly Observed TreatmentPatients receive DOT as normal - involves patient going to polyclinic to be observed taking treatment every day |
| Treatment | Experimental | Behavioral: Virtually Observed TreatmentPatients receive VOT - involves patient sending a video of themselves taking their treatment over M-health app which will be reviewed remotely by observers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consent to being part of the trial
- Live in Chisinau and no plans to move away from Chisinau during the four months
- Aged 18 or over
- At least four months of care remaining
Key exclusion criteria (6 listed)
- Having MDR-TB
- Homeless
- Is not homeless
- Suffer from alcoholism or drug misuse
- In prison
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 |
|---|---|---|
| Virtually Observed Treatment | Behavioural | Treatment |
| Directly Observed Treatment | Other | Control |
Primary outcome
Adherence to medication
Time frame: 2 weeks
Number of days per two week period that each patient fails to adhere to treatment, continuous. Panel data collected from TB-01 record sheets for duration of patient continuation phase of treatment - on average 5 months
8 secondary outcomes
Adherence 80%
Time frame: 2 weeks
Patient wellbeing
Time frame: Collected at 4 months
Patient satisfaction
Time frame: Collected at 4 months
Travel and time cost of treatment borne by patient, self reported.
Time frame: Collected at 4 months
Employment, self reported
Time frame: Collected at 4 months
Treatment success
Time frame: Collected at 4 months
Body mass index (BMI)
Time frame: Collected at 4 months
Side effects reported during treatment
Time frame: Collected at 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
- Derived from this study: PubMed 32381495Ravenscroft L, Kettle S, Persian R, Ruda S, Severin L, Doltu S, Schenck B, Loewenstein G. Video-observed therapy and medication adherence for tuberculosis patients: randomised controlled trial in Moldova. Eur Respir J. 2020 Aug 6;56(2):2000493. doi: 10.1183/13993003.00493-2020. Print 2020 Aug.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Virtually Observed Treatment and Directly Observed Treatment in people with Tuberculosis, run by The Behavioural Insights Team.
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 6 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: status not confirmed, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stewart Kettle Kettle, msc (+44 (0) 207 031 3530, stewart.kettle@behaviouralinsights.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to medication (time frame: 2 weeks). 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 NCT02331732, which also lists 1 linked publication.
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 25 Sep 2015.