An evaluation of psycho-educational intervention in older adults with mild intellectual impairment, using a combination of randomised controlled trial and n=1 methodology

ISRCTN	ISRCTN79696722
DOI	https://doi.org/10.1186/ISRCTN79696722
Secondary identifying numbers	265/393

Submission date: 10/09/2002
Registration date: 10/09/2002
Last edited: 28/10/2016

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

Prof Gordon K Wilcock
Scientific

Department of Care of the Elderly
University of Bristol
Frenchay Hospital
Bristol
BS18 1LE
United Kingdom

Phone	+44 (0)117 975 3948
Email	gordon.wilcock@bristol.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	An evaluation of psycho-educational intervention in older adults with mild intellectual impairment, using a combination of randomised controlled trial and n=1 methodology
Study acronym	BPI
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Dementia or cognitive impairment
Intervention	Bristol Psycho-educational Intervention Group (BPI): The BPI group will comprise of two phases - Phase 1 will be six, weekly group meetings each lasting up to two hours. Individuals will be informed about memory functioning, will identify their own disabilities and handicaps, will learn strategies of memory management, and undertake personal behavioural goal setting. Time will be given to explore specific problems brought to the group using group problem solving techniques. Phase 2 will consist of six group meetings, three at fortnightly intervals, and three at monthly intervals. The focus of this phase will be to consolidate skills and continue with personal behavioural goal setting. Non-directive Support Group (NDSG): The NDSG group will meet the same number of times at the same intervals as the BPI group but staggered to aid recruitment. The group will be led by two nurses with relevant clinical experience and will offer non-directive supportive therapy. This group will provide the opportunity to share experiences and talk about feelings without offering either a formal education or rehabilitation programme. The Non-directive Support Group is designed to control for the effects of regular follow-up and contact with healthcare professionals.
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2002
Completion date	31/12/2002

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	The intervention will be offered to individuals aged 55 years or over with mild cognitive impairment, defined as Clinician's Dementia Rating score of 0.5 or 1. This is likely to include people with a stable cognitive impairment as well as individuals whose condition is expected to deteriorate and those with an established diagnosis of early dementia (Ritchie & Kildea 1995. Both patient and partner will be in daily contact and will have expressed an interest in, or concern about, learning to manage these difficulties when seen in the Bristol Memory Disorders Clinic (BMDC) by the clinic doctor. Patients and partners will usually live within a 45-min drive of Blackberry Hill Hospital.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2002
Date of final enrolment	31/12/2002

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Care of the Elderly

Bristol
BS18 1LE
United Kingdom

Sponsor information

The Health Foundation (UK)
Charity

90 Long Acre
London
WC2E 9RA
United Kingdom

Phone	+44 (0)20 7257 8000
Email	info@health.org.uk
Website	http://www.pppfoundation.org.uk/
"ROR"	https://ror.org/02bzj4420

Funders

Funder type

Charity

The Health Foundation (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

Editorial Notes

28/10/2016: No publications found, verifying study status with principal investigator