Decision-making competence in people with learning disabilities: can accessible information make the difference between consent and informed consent?
ISRCTN | ISRCTN14652553 |
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DOI | https://doi.org/10.1186/ISRCTN14652553 |
Secondary identifying numbers | N0530118484 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 07/11/2014
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Annetta Bouius
Scientific
Scientific
Islington Learning Disabilities Partnership
1 Lowther Road
London
N7 8SU
United Kingdom
Phone | +44 (0)20 7527 6620 |
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Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | |
Study objectives | What are the factors that influence the decision-making abilities of people with learning disabilities? How can decision-making skills and abilities of people with learning disabilities be enhanced through the way in which we explain information? |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Learning difficulties |
Intervention | 1. Hypothetical dental procedure explained to participants using verbal method of explanation 2. Same dental procedure explained using equivalent accessible information form of explanation, interviews |
Intervention type | Other |
Primary outcome measure | Informing an individual in a way that works with their skills and abilities would ensure that individual is given every opportunity to participate in the decisions being made in their lives. |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/2003 |
Completion date | 31/12/2003 |
Eligibility
Participant type(s) | Healthy volunteer |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 20 |
Key inclusion criteria | 15-20 healthy volunteers who are service users of a range of services which provide services for people with learning disabilities, including Centre 404, Elfrida Society, Islington Learning Disabilities Partnership, etc. |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/01/2003 |
Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Islington Learning Disabilities Partnership
London
N7 8SU
United Kingdom
N7 8SU
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
North Central London Community Research Consortium (UK)
No information available
Results and Publications
Intention to publish date | |
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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 |