Tuberculosis
Conditions
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.
Interventions
OTHERDirectly Observed Treatment
BEHAVIORALVirtually Observed Treatment
Sponsors
The Behavioural Insights Team
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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) |
| 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 |
| 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 |
| 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) |
| 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) |
Contacts
Primary ContactStewart Kettle Kettle, msc
Outcome results
None listed