Virtually Observed Treatment (VOT) for Tuberculosis Patients in Moldova

Tuberculosis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02331732
• Other study ID #: 201405*
• Status: Not yet recruiting
• Phase: N/A
• First received: December 13, 2014
• Last updated: September 23, 2015
• Start date: October 2015
• Est. completion date: March 2017

Study information

• Verified date: September 2015
• Source: The Behavioural Insights Team
• Contact: Stewart Kettle Kettle, msc
• Phone: +44 (0) 207 031 3530
• Email: stewart.kettle[@]behaviouralinsights.co.uk
• Is FDA regulated: No
• Health authority: Moldova: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Behavioral:
• Virtually Observed Treatment

Other:
• Directly Observed Treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Behavioural Insights Team

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Treatment success	Binary variable equal to 1 if treatment recorded a success on TB-01 patient record at 4 months	Collected at 4 months	No
Secondary	Body mass index (BMI)	Body mass index (BMI), measured at 4 months	Collected at 4 months	No
Secondary	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	No