Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova

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 Overview

• Status: Unknown
• Conditions: Tuberculosis
• Intervention / Treatment: Other: Directly Observed Treatment; Behavioral: Virtually Observed Treatment

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Patients receive DOT as normal - involves patient going to polyclinic to be observed taking treatment every day	Other: Directly Observed Treatment
Experimental: 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	Behavioral: Virtually Observed Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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)	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)	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)	Collected at 4 months
Treatment success	Binary variable equal to 1 if treatment recorded a success on TB-01 patient record at 4 months	Collected at 4 months
Body mass index (BMI)	Body mass index (BMI), measured at 4 months	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)	Collected at 4 months

Collaborators and Investigators

• Sponsor: The Behavioural Insights Team

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: December 13, 2014
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Estimate): September 25, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: 201405*