Condition category
Nervous System Diseases
Date applied
17/03/2010
Date assigned
31/03/2010
Last edited
02/12/2010
Prospective/Retrospective
Prospectively 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

Prof Linda Clare

ORCID ID

Contact details

School of Psychology
Adeilad Brigantia
Penrallt Road
Bangor
LL57 2AS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

85327

Study information

Scientific title

Development of an awareness-based intervention to enhance quality of life in severe dementia: a cluster randomised trial across 8 care homes

Acronym

Study hypothesis

Providing care staff with an observational tool that can help to identify evidence of awareness in residents with severe dementia, supported by appropriate training and supervision, will lead to improvements.

Ethics approval

North West Wales Research Ethics Committee approved on the 17th October 2008 (ref: 08/WNo01/60)

Study design

Cluster randomised trial of an observational measure of awareness

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please contact catherine.quinn@bangor.ac.uk to request a patient information sheet

Condition

Dementia

Intervention

Care staff in homes allocated to the intervention condition will be trained and mentored in using an observational measure of awareness with selected residents over an 8-week period.

The control group will consist of 4 care homes, which will be paired with 4 care homes receiving the intervention. Baseline assessments will be conducted at the control homes after which they will receive no additional input for the 8 week period in which other homes will be receiving the intervention.

Follow-up assessments will be conducted at both homes after the end of the intervention period.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Care staff:
1.1. Staff attitudes: Approaches to Dementia Questionnaire (ADQ)
1.2. Care practice: The Dementia Care Practitioner's Assessment (DCPA)
1.3. Well-being: Maslach Burnout Inventory (MBI); General Health Questionnaire (GHQ-12)

2. Assessment of the person with dementia:
2.1. Behaviour: Behavioural Assessment Scale Of Later Life (BASOLL)
2.2. Well-being: Positive Response Scale (PRS)
2.3. Quality of life: Quality of Life in Late-stage Dementia (QUAL-ID)

All measured at baseline and at the end of the 8 week intervention period.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/06/2010

Overall trial end date

28/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Care staff:
1.1. Working in the identified homes
1.2. All ages, either sex
1.3. Permanent employees
1.4. Have been in post for at least six months
1.5. Work at least 15 hours per week

2. Individuals:
2.1. All ages, either sex
2.2. Severe dementia
2.3. Have no, or only very limited, verbal communication

Participant type

Patient

Age group

Other

Gender

Not Specified

Target number of participants

Up to 80 care staff, observing in total 80 residents with severe dementia

Participant exclusion criteria

1. Agency staff
2. Staff who are unable to communicate effectively in English
3. Individuals with dementia who are wholly or largely confined to bed

Recruitment start date

01/06/2010

Recruitment end date

28/02/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Psychology
Bangor
LL57 2AS
United Kingdom

Sponsor information

Organisation

Bangor University (UK)

Sponsor details

School of Psychology
Brigantia Building
Bangor University
Bangor
LL57 2AS
United Kingdom

Sponsor type

University/education

Website

http://www.bangor.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (UK) (ref: 85327)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20579370

Publication citations

  1. Protocol

    Clare L, Woods RT, Whitaker R, Wilson BA, Downs M, Development of an awareness-based intervention to enhance quality of life in severe dementia: trial platform., Trials, 2010, 11, 73, doi: 10.1186/1745-6215-11-73.

Additional files

Editorial Notes