Extrait

Background and study aims Tuberculosis (TB) control is founded on the basis of early diagnosis to reduce the risk of onward transmission to others, and the patient completing an effective course of treatment for a minimum of 6 months to cure the disease. In the UK, TB patients at high risk of poor adherence to TB treatment are recommended to have directly observed treatment (DOT - where a responsible adult watches the patient swallow each dose) to minimise the risk of relapse, drug resistance and spread of infection, but it is not widely used. Groups eligible for DOT include patients with social risk factors (including alcohol or drug use, history of imprisonment, homelessness), mental health problems, evidence of poor adherence, previous TB treatment and clinically complex disease requiring extra support. In the UK, a high proportion of patients who are recommended for DOT do not receive DOT. Whilst DOT has been recommended in the USA, it can be time consuming for both patients and the care provider. Recently the University of San Diego has developed a smartphone app allowing patients to easily submit a video recording of themselves taking treatment to a secure server for remote viewing by a health care worker (video observed treatment – VOT) to save travel time required to conduct DOT. This has been shown to be effective and highly acceptable in non-socially complex cases in the USA but has not been tested in more socially complex patients such as those recommended for DOT in the UK. Our study team have pioneered the use of VOT with the pan London Find&Treat TB outreach service without the use of a dedicated smartphone app in socially complex cases in London and again found it to be highly acceptable to patients. We are collaborating with the University of San Diego to use their VOT app in a study comparing the effectiveness of VOT versus DOT in UK patients eligible for DOT. Who can participate? All TB patients, male or female, 16 years of age or older at participating sites who meet national or local guidance for DOT. What does the study involve? Participants requiring once a day TB treatment will be recruited over a two-year period and randomly allocated to either DOT organised by the TB clinic or VOT organised by the research team. In addition, a small number of TB patients with multi-drug resistant TB requiring more than once daily treatment will be recruited into a group where VOT alone is offered. The VOT group will submit VOT clips using a dedicated smartphone with a pre-loaded app allowing upload to a secure server. Participants will be trained in how to lay out each drug on a labelled laminated medication sheet with a space for each drug and take each drug individually whilst recording the VOT clip on the smartphone. VOT clips will be submitted automatically as soon as the phone is connected to a cellular data network (data plan provided with phone) or a wireless network. VOT clips will be read by a study nurse/VOT observer daily during weekdays with weekend clips read on Mondays. For the DOT group, a trained health professional, or a responsible lay person supported by a trained health professional, provides the prescribed medication and observes the patient swallowing every dose (or for some schedules observing doses during weekdays with self-administered therapy at weekends). Organised by the TB clinic, DOT will be delivered according to usual practice. What are the possible benefit and risks of participating? Observing participants take their treatment will improve their chances of completing the full course and being cured. At the moment most TB patients having DOT are expected to attend the clinic but this study will show whether patients on DOT should be given more choices on where and how their treatment should be organised. Participants will also making an important contribution to the future treatment of patients with TB. The following will be considered as potential risks: loss to follow up; death from TB; breaches of data security; violence to study personnel during the course of participant interaction; complaints about the study from participants or participating centres; adverse drug reactions. Where is the study run from? This study has been set up by the Royal Free NHS Foundation Trust in collaboration with “Find&Treat” under the University College London Hospitals NHS Foundation Trust. The study centre is located at the Farr Institute, University College London, UK. When is the study starting and how long is it expected to run for? It is anticipated that recruitment will start at the end of September 2014 and will run for 2 years. Participants will then be followed up over a period of 12 months. Who is funding the study? National Institute for Health Research (NIHR) (UK). Who is the main contact? The main contact is Prof Andrew Hayward ([email protected]) Other contacts: Dr Rob Aldridge ([email protected]) and Elizabeth Garber ([email protected])

Critère d'inclusion

• Topic: Respiratory disorders; Subtopic: Respiratory (all Subtopics); Disease: Respiratory

Liens

• ictrp
• isrctn