Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova

Not Applicable

• Conditions: Tuberculosis
• Interventions: Other: Directly Observed Treatment; Behavioral: Virtually Observed Treatment

• Registration Number: NCT02331732
• Lead Sponsor: The Behavioural Insights Team

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-13
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-23
• Last Update Posted: 2015-09-25
• Study Start: 2015-10
• Primary Completion: 2017-02
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Consent to being part of the trial
2. Live in Chisinau and no plans to move away from Chisinau during the four months
3. Aged 18 or over
4. At least four months of care remaining

Exclusion Criteria

1. Having MDR-TB
2. Homeless
3. Is not homeless
4. Suffer from alcoholism or drug misuse
5. In prison
6. Has a treatment regimen with injections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Directly Observed Treatment	Patients receive DOT as normal - involves patient going to polyclinic to be observed taking treatment every day
Treatment	Virtually Observed Treatment	Patients receive VOT - involves patient sending a video of themselves taking their treatment over M-health app which will be reviewed remotely by observers

Primary Outcome Measures

Name	Time	Method
Adherence to medication	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

Secondary Outcome Measures

Name	Time	Method
Patient wellbeing	Collected at 4 months	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
Employment, self reported	Collected at 4 months	Binary variable equal to 1 if patient currently does any work for pay or profit (questionnaire, self-reported)
Patient satisfaction	Collected at 4 months	Binary variable equal to 1 if a patient gives a positive response about their treatment on a likert scale (questionnaire, self-reported)
Side effects reported during treatment	Collected at 4 months	Binary variable equal to 1 if patient reported any side effects during treatment (questionnaire, self-reported)
Adherence 80%	2 weeks	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
Travel and time cost of treatment borne by patient, self reported.	Collected at 4 months	Total travel time and cost over 4 months (derived from questionnaire, self-reported)
Treatment success	Collected at 4 months	Binary variable equal to 1 if treatment recorded a success on TB-01 patient record at 4 months
Body mass index (BMI)	Collected at 4 months	Body mass index (BMI), measured at 4 months