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
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

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

Phone +44 (0)20 7527 6620

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesWhat 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) studiedMental and Behavioural Disorders: Learning difficulties
Intervention1. 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 typeOther
Primary outcome measureInforming 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 measuresNot provided at time of registration
Overall study start date01/01/2003
Completion date31/12/2003

Eligibility

Participant type(s)Healthy volunteer
Age groupNot Specified
SexNot Specified
Target number of participants20
Key inclusion criteria15-20 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 criteriaNot provided at time of registration
Date of first enrolment01/01/2003
Date of final enrolment31/12/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Islington Learning Disabilities Partnership
London
N7 8SU
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

North Central London Community Research Consortium (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan