An awareness-based intervention to enhance quality of life in severe dementia

ISRCTN ISRCTN59507580
DOI https://doi.org/10.1186/ISRCTN59507580
Secondary identifying numbers 85327
Submission date
17/03/2010
Registration date
31/03/2010
Last edited
28/08/2018
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

Prof Linda Clare
Scientific

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

Study information

Study designCluster randomised trial of an observational measure of awareness
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please contact catherine.quinn@bangor.ac.uk to request a patient information sheet
Scientific titleDevelopment of an awareness-based intervention to enhance quality of life in severe dementia: a cluster randomised trial across 8 care homes
Study objectivesProviding 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(s)North West Wales Research Ethics Committee approved on the 17th October 2008 (ref: 08/WNo01/60)
Health condition(s) or problem(s) studiedDementia
InterventionCare 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 typeOther
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date01/06/2010
Completion date28/02/2012

Eligibility

Participant type(s)Patient
Age groupOther
SexNot Specified
Target number of participantsUp to 80 care staff, observing in total 80 residents with severe dementia
Key inclusion criteria1. 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
Key exclusion criteria1. Agency staff
2. Staff who are unable to communicate effectively in English
3. Individuals with dementia who are wholly or largely confined to bed
Date of first enrolment01/06/2010
Date of final enrolment28/02/2012

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

School of Psychology
Bangor
LL57 2AS
United Kingdom

Sponsor information

Bangor University (UK)
University/education

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

Website http://www.bangor.ac.uk/
ROR logo "ROR" https://ror.org/006jb1a24

Funders

Funder type

Research council

Medical Research Council (UK) (ref: 85327)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 25/06/2010 Yes No
Results article results of tool development 01/06/2012 Yes No
Results article results of RCT 01/01/2013 Yes No

Editorial Notes

28/08/2018: Publication reference added.