Does befriending by trained lay workers improve psychological well-being and quality of life for carers of people with dementia, and at what cost?: a randomised controlled trial.

ISRCTN	ISRCTN08130075
DOI	https://doi.org/10.1186/ISRCTN08130075
Secondary identifying numbers	HTA 99/34/07

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 25/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Georgina Charlesworth
Scientific

Lecturer in Clinical & Hlth Psychology of Old Age
Centre for Behavioural & Social Science in Medicine
University College London
67-73 Charles Bell House
London
W1W 7EJ
United Kingdom

Phone	+44 (0)207 679 9334
Email	g.charlesworth@ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Scientific title
Study acronym	BECCA
Study objectives	1. To randomly allocate carers of people with dementia to one of two groups (access to an employed befriending facilitator vs. usual care) and follow-up for 3 years post-randomisation in order to compare: carer stress and coping strategies, quality of life in both the carers and people with dementia; resources use; and survival. 2. To document direct and indirect costs in both the intervention and control group, calculating the costs from the perspective of health, social and voluntary services and families involved in dementia care, and establish incremental cost-effectiveness. 3. To employ a befriending facilitator to collaborate with relevant voluntary agencies in recruiting, training and supporting befrienders, and matching befrienders to care dyads. 4. To disseminate project outputs including: effectiveness and cost effectiveness; model of befriender support and training. Please note that the target number of participants was added as of 25/08/2009.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Nervous system diseases: Dementia
Intervention	Access to an employed befriending facilitator vs. standard care
Intervention type	Other
Primary outcome measure	Carer stress and coping strategies, quality of life in both the carers and people with dementia
Secondary outcome measures	Not provided at time of registration.
Overall study start date	01/01/2002
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	236
Key inclusion criteria	Carers of people with dementia
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/01/2002
Date of final enrolment	30/09/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Lecturer in Clinical & Hlth Psychology of Old Age

London
W1W 7EJ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

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?
Other publications	HTA monograph	01/03/2008		Yes	No
Results article	results	07/06/2008		Yes	No