Feeling Well with True Colours for community patients
| ISRCTN | ISRCTN16778756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16778756 |
| Secondary identifying numbers | 14330 |
- Submission date
- 08/08/2013
- Registration date
- 08/08/2013
- Last edited
- 24/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The management of mental illness involves collaboration between the patient and the health care professional. A key part of this collaboration is patients monitoring of their symptoms and problems themselves. However, it is widely acknowledged that regular monitoring of symptoms is difficult to maintain, and yet these are typically lifelong conditions. We need a straightforward, user-friendly technology that allows patients to self-monitor relatively effortlessly, and enables the resulting data to be shared by the patient with their key clinicians. True Colours has been developed to facilitate such self-monitoring in common mental illnesses, including bipolar disorder, schizophrenia, depression and anxiety, and common associated problems, including alcohol and substance misuse. It is, therefore, potentially a useful clinical tool for use by Community Mental Health Teams (CMHTs) and their patients in the UK. We need to find out whether this service, Feeling Well with True Colours, works and is cost effective when adopted by UK CMHTs.
Who can participate?
All 11 CMHTs in Oxford Health NHS Foundation Trust, UK will take part in this study.
What does the study involve?
The order in which the participating CMHTs introduce True Colours will be randomly decided ('by the flip of a coin'). All 11 CMHTs will introduce the service, and we will compare the information gathered by each CMHT before and after the start of the service.
What are the possible benefits and risks of participating?
Patients may benefit from managing their mental illness better if this is adopted by the CMHTs. There are no anticipated risks for participants or CMHTs.
Where is the study run from?
The study is run from Oxford Health NHS Foundation Trust covering Oxfordshire and Buckinghamshire, UK.
When is study starting and how long is it expected to run for?
Training for CMHTs begins in June 2013 and will be completed by the end of December 2013.
Who is funding the study?
The National Institute for Health Research (NIHR), UK.
Who is the main contact?
Dr Jean Christensen
oxtext@psych.ox.ac.uk
Tel: +44 (0)1865 613131
Contact information
Scientific
Department of Psychiatry
Warneford Hospital
Warneford Lane Headington
Oxford
OX3 7JX
United Kingdom
| jean.christensen@psych.ox.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please contact oxtext@psych.ox.ac.uk to request a patient information sheet |
| Scientific title | Stepped wedge cluster randomised controlled trial of Feeling Well with True Colours for community patients in Oxford Health NHS Foundation Trust: quantitative evaluation |
| Study acronym | OXTEXT-7: Quantitative evaluation |
| Study objectives | Feeling Well With True Colours (FWwTC) is a series of 6 booklets that have been designed to be used with the True Colours self-monitoring and management system. The booklets cover a wider range of mental health disorders, including, bipolar disorder, unipolar depression, anxiety, schizophrenia and psychosis, alcohol and substance misuse and managing medicines. Likewise the True Colours electronic monitoring system has been expanded to include new questionniares for monitoring the above conditions. Previously True Colours has only been used with bipolar disorder. This study will evaluate whether: 1. Feeling Well with True Colours is as effective with other mental health disorders as it is with bipolar disorder. 2. Whether Feeling Well with True Colours improves health outcomes, and is cost-effective, when rolled out across all of the Adult Community Mental Health Teams (CMHTs) in Oxford Health NHS Foundation Trust. |
| Ethics approval(s) | 13/SC/0070; First MREC approval date 15/03/2013 |
| Health condition(s) or problem(s) studied | Topic: Mental Health Research Network; Subtopic: Service Delivery; Disease: Not Applicable |
| Intervention | Feeling Well with True Colours, will be offered to every patient in a CMHT who the clinician (doctor, nurse, psychologist, other therapist) feels would benefit from developing self-monitoring and self-management skills. The intervention comprises two elements: 1. self-monitoring of symptoms via the True Colours system 2. patient education about self-monitoring, via Feeling Well materials Follow Up Length: 15 month(s); Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure | Health of the Nation Outcome Scales (HoNOS) Score; Timepoint(s): monthly |
| Secondary outcome measures | 1. Change in DH Mental Health Clusters (derived from HoNOS) at CMHT level every month. 2. Number of face-to-face-contacts V non face-to-face contacts collected monthly for each CMHT. 3. Length of stay on CMHT caseload collected monthly for each CMHT. 4. Number of hospital admissions/discharges/length of stay on wards collected monthly and mapped to CMHTs. 5. Number of emergency re-admissions for each ward collected monthly and mapped to CMHTs. 6. Number of admissions under Mental Health Act Section for each ward collected monthly and mapped to CMHTs. 7. Missed appointments by staff collected monthly for each CMHT. 8. Missed appointments by patients collected monthly for each CMHT. 9. Appointments cancelled by staff collected monthly for each CMHT. 10. Appointments cancelled by patients or staff collected monthly for each CMHT. 11. Staff performance measures collected monthly for each CMHT, including: 11.1. Sickness levels 11.2. Unfilled vacancy levels 11.3. Staff turnover 11.4. Staff stability 11.5. Staff costs |
| Overall study start date | 01/06/2013 |
| Completion date | 31/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 500; UK Sample Size: 500; Description: 11 adult CMHTs. Study team advised sample size will be between 500-2000 participants 1/7/13. |
| Key inclusion criteria | The unit of randomisation for this trial will be 11 adult Community Mental Health Team (CMHT) of Oxford Health NHS Foundation Trust covering the two counties of Oxfordshire and Buckinghamshire. Strictly, the study participants are, therefore, clinical teams, rather than patients. CMHTs will be included if they are: An Adults of Working Age Community Mental Health Team(CMHT) located in Oxfordshire or Buckinghamshire (and therefore part of Oxford Health NHS Foundation Trust). Clinicians working within the CMHTs will decide to which patients it is appropriate to offer FWwTC. It is likely that these patients will: 1. Have any psychiatric disorder or disorders 2. Be able, in the view of the managing clinician, to benefit from self-monitoring and management 3. Be able to weigh the pros and cons of using FWwTC, and make a decision on what they want to do 4. Be able to use SMS (text messaging) or email/internet 5. Have reasonable written and spoken English. Target Gender: Male & Female ; Lower Age Limit 18 years |
| Key exclusion criteria | Only those implied by the inclusion criteria. |
| Date of first enrolment | 01/06/2013 |
| Date of final enrolment | 31/01/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
OX3 7JX
United Kingdom
Sponsor information
University/education
Department of Psychiatry
Warneford Hospital
Warneford Lane
Headington
Oxford
OX3 7JX
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
24/08/2016: No publications found, verifying study status with principal investigator
