Condition category
Nervous System Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
25/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Georgina Charlesworth

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 99/34/07

Study information

Scientific title

Acronym

BECCA

Study hypothesis

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

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Nervous system diseases: Dementia

Intervention

Access to an employed befriending facilitator vs. standard care

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2002

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Carers of people with dementia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

236

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/01/2002

Recruitment end date

30/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Lecturer in Clinical & Hlth Psychology of Old Age
London
W1W 7EJ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/18284895
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18505757

Publication citations

  1. Results

    Charlesworth G, Shepstone L, Wilson E, Reynolds S, Mugford M, Price D, Harvey I, Poland F, Befriending carers of people with dementia: randomised controlled trial., BMJ, 2008, 336, 7656, 1295-1297, doi: 10.1136/bmj.39549.548831.AE.

  2. Charlesworth G, Shepstone L, Wilson E, Thalanany M, Mugford M, Poland F, 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., Health Technol Assess, 2008, 12, 4, iii, v-ix, 1-78.

Additional files

Editorial Notes