NCT02331732

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 25, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

December 13, 2014

Last Update Submit

September 23, 2015

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Adherence 80%

    2 weeks

  • Patient wellbeing

    Collected at 4 months

  • Patient satisfaction

    Collected at 4 months

  • Travel and time cost of treatment borne by patient, self reported.

    Collected at 4 months

  • Employment, self reported

    Collected at 4 months

  • +3 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients receive DOT as normal - involves patient going to polyclinic to be observed taking treatment every day

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

Behavioral: Virtually Observed Treatment

Interventions

Virtually Observed TreatmentBEHAVIORAL
Treatment
Directly Observed TreatmentOTHER
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having MDR-TB
  • Homeless
  • Is not homeless
  • Suffer from alcoholism or drug misuse
  • In prison
  • Has a treatment regimen with injections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32381495DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Central Study Contacts

Stewart Kettle Kettle, msc

CONTACT

+44 (0) 207 031 3530stewart.kettle@behaviouralinsights.co.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2014

First Posted

January 6, 2015

Study Start

October 1, 2015

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

September 25, 2015

Record last verified: 2015-09