A randomised controlled multi-centre treatment trial of adolescent anorexia nervosa, including assessment of cost effectiveness and patient acceptability
| ISRCTN | ISRCTN39345394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39345394 |
| Secondary identifying numbers | HTA 97/42/02 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 16/08/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Simon Gowers
Scientific
Scientific
Department of Psychiatry
University of Liverpool
Academic Unit
Pine Lodge
79 Liverpool Road
Chester
CH2 1AW
United Kingdom
| Phone | +44 (0)1244 364660 |
|---|---|
| s.gowers@liv.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | TOUCAN |
| Study objectives | To evaluate, by means of a randomised controlled trial, the cost effectiveness of inpatient against outpatient treatment of adolescent anorexia nervosa and general against specialist treatment, with the following hypotheses: 1. There will be no difference in clinical outcome between inpatient and outpatient treatment in the medium and long term (1 and 2 years) by intention to treat. 2. Specialist outpatient treatment will be more clinically and cost effective than general outpatient treatment. 3. Outpatient treatment will be more cost effective than inpatient treatment. 4. Outpatient treatment will be more acceptable to subject and family in terms of general satisfaction and quality of life. Please note that, as of 15/01/2008, the anticipated end date of this trial has been updated from 30/06/2004 to 31/12/2008. Please note that, as of 28/0/2009, the anticipated end date of this trial has been updated from 31/12/2008 to 30/06/2009. |
| Ethics approval(s) | Does not match inclusion criteria |
| Health condition(s) or problem(s) studied | Anorexia nervosa |
| Intervention | 1. Routine outpatient treatment by CAMHS 2. Specialist outpatient treatment package (12 sessions) as used in existing Chester service 3. Inpatient treatment. |
| Intervention type | Other |
| Primary outcome measure | Composite clinical measure of physical, social and psychological outcome based on Morgan and Russell Scales (MRAOS). |
| Secondary outcome measures | 1. Percentage weight for height 2. Family functioning 3. Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA) 4. Patient and family acceptablity |
| Overall study start date | 01/01/2000 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 167 |
| Key inclusion criteria | 1. All new cases of (Diagnostic and Statistical Manual of Mental Disorders, Fourth edition [DSM IV]) anorexia nervosa 2. Aged 12 - 18 years inclusive 3. Presenting to Child and Adolescent Mental Health Services (CAMHS), Regional Adolescent Services, or Specialist Eating Disorder Services in the North West Region over a two year period |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Psychiatry
Chester
CH2 1AW
United Kingdom
CH2 1AW
United Kingdom
Sponsor information
University of Liverpool (UK)
University/education
University/education
Research Support Office
The Foresight Building
3 Brownlow Street
Liverpool
L69 3GL
England
United Kingdom
| Website | http://www.liv.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
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? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2007 | Yes | No | |
| Results article | results | 01/03/2010 | Yes | No |
