Decision-making competence in people with learning disabilities: can accessible information make the difference between consent and informed consent?

ISRCTN	ISRCTN14652553
DOI	https://doi.org/10.1186/ISRCTN14652553
Protocol serial number	N0530118484
Sponsor	Department of Health (UK)
Funder	North Central London Community Research Consortium (UK)

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

Ms Annetta Bouius
Scientific

Islington Learning Disabilities Partnership
1 Lowther Road
London
N7 8SU
United Kingdom

Phone	+44 (0)20 7527 6620

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2003

Participant type(s)	Healthy volunteer
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

Islington Learning Disabilities Partnership

London
N7 8SU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan