Virtually Observed Treatment (VOT) for TB Patients in The Republic of Moldova
Last registered on December 13, 2014

Pre-Trial

Trial Information
General Information
Title
Virtually Observed Treatment (VOT) for TB Patients in The Republic of Moldova
RCT ID
AEARCTR-0000579
Initial registration date
December 12, 2014
Last updated
December 13, 2014 6:55 AM EST
Location(s)
Primary Investigator
Affiliation
The University of Bristol
Other Primary Investigator(s)
PI Affiliation
The Behavioural Insights Team
Additional Trial Information
Status
In development
Start date
2015-02-02
End date
2015-12-22
Secondary IDs
Abstract
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 200 TB patients during their ‘continuation phase’ of treatment. The trial will have two arms; 100 patients will form the control group and receive the standard provision of Directly Observed Treatment (DOT) and 100 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 calling 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. The trial design will be implemented by Act for Involvement (AFI) and the Ministry of Health in Moldova. The trial will be available to patients that have access to a computer, smartphone or any device that can run Skype. Two VOT observation centres will be set up; one at AFI and one in an existing polyclinic. The trial duration will dependent on the number of eligible patients but is expected to take 16 months.
External Link(s)
Registration Citation
Citation
Kettle, Stewart and Luke Ravenscroft. 2014. "Virtually Observed Treatment (VOT) for TB Patients in The Republic of Moldova ." AEA RCT Registry. December 13. https://www.socialscienceregistry.org/trials/579/history/3257
Sponsors & Partners

There are documents in this trial unavailable to the public. Use the button below to request access to this information.

Request Information
Experimental Details
Interventions
Intervention(s)
The Republic of Moldova has one of the highest documented levels of MDR-TB in the world (WHO, 2013) . The Ministry of Health has followed the WHO-recommended DOT (Directly Observed Treatment) during 2000-2004 and has used the Stop TB Strategy which includes DOT since 2006 (WHO, 2013). DOT is recommended by WHO as the best curative method for TB. Based on a small sample of patient interviews we think that for some patients DOT may be a hindrance rather than a help. The way that DOT is currently implemented in Moldova means that patients have to visit a doctor or nurse every day in order to be observed taking treatment. This is time consuming, can cost patients money, and adds a significant friction cost for patients. The alternative, for DOTs to be administered at home by roving personnel, is resource intensive and currently only available to a small number of patients in Moldova. VOT differs from DOT in that the daily observation of patients taking their medication will be observed via internet video calling rather than in-person. This should save patients a huge amount of time and money. Given the prevalence of side effects of medication, being able to take medication at home may also increase patient wellbeing.
Intervention Start Date
2015-02-02
Intervention End Date
2015-11-02
Primary Outcomes
Primary Outcomes (end points)
The primary outcome measure for the trial will be the number of days per two week period that each patient fails to adhere to treatment (continuous). Only patients that are observed will be counted. This will be collected continuously through observation.
There will be a number of secondary outcome measures:
1) Proportion of patients having more than 80% of scheduled medication sessions (binary) observed in participants with a minimum of 6 weeks follow up data. This is the target adherence rate used for a forthcoming trial of VOT by the NHS in the UK.
2) 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 – collected at baseline and at 4 months
3) Patient satisfaction. Whether a patient gives a positive response about their treatment on a likert scale (binary) – collected at baseline and at 4 months.
4) Travel and time cost of treatment borne by patient, (self reported, continuous) – collected at 4 months.
5) Employment (binary) – collected at baseline and at 4 months.
6) Treatment success (binary) – collected at 4 months.
7) Body mass index (BMI) (continuous) – collected at baseline and at 4 months.
8) Side effects (self-reported, categorical) - collected at baseline and at 4 months.
We will also conduct a number of qualitative interviews with patients, non-randomly selecting a range of people and levels of adherence.
Adherence is regularly recorded on patient TB-01 record sheets at TB polyclinics. The time dimension of this data will give us additional power to detect results for the primary outcome measure. The trial will collect four months of adherence data for each patient. Trial duration is longer than data collection for each patient since patients will be starting their continuation phase treatment at different times. The patient wellbeing questionnaire will be conducted during the fourth month of treatment in the ambulatory phase for each patient. Additionally this questionnaire will include questions on the time and cost of patient travel to their polyclinic in order to quantify the money saved by patients receiving VOT.
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The trial will work as a consent-randomise individually randomised trial. Initially patients in the intensive phase in Chisinau will be questioned in order to determine their eligibility to take part in the trial based on certain criteria. Patients that meet the criteria will then be given information on the trial and decide whether they want to participate. Those that meet the eligibility criteria and give consent will be randomised into receiving VOT or DOT.
Experimental Design Details
Randomization Method
As per above participant selection timeline randomisation will be conducted on a web based platform developed by BIT. Patients will be randomly assigned to the control group (DOT) or the treatment arm (VOT) with a 50% chance of being in each group. An on-line randomisation tool will be set up for the implementing partner.
Randomization Unit
Individual
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
No clusters
Sample size: planned number of observations
3384 biweekly adherence
Sample size (or number of clusters) by treatment arms
200 Individuals
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
0.75 day shift in patient adherence (per 2 weeks of treatment). 0.41 st deviations
Supporting Documents and Materials

There are documents in this trial unavailable to the public. Use the button below to request access to this information.

Request Information
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
University College London
IRB Approval Date
2014-11-27
IRB Approval Number
2220/001
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers