An awareness-based intervention to enhance quality of life in severe dementia
| ISRCTN | ISRCTN59507580 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59507580 |
| Protocol serial number | 85327 |
| Sponsor | Bangor University (UK) |
| Funder | Medical Research Council (UK) (ref: 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
Scientific
School of Psychology
Adeilad Brigantia
Penrallt Road
Bangor
LL57 2AS
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomised trial of an observational measure of awareness |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Development of an awareness-based intervention to enhance quality of life in severe dementia: a cluster randomised trial across 8 care homes |
| Study objectives | 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(s) | North West Wales Research Ethics Committee approved on the 17th October 2008 (ref: 08/WNo01/60) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | 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. |
| Key secondary outcome measure(s) | No secondary outcome measures |
| Completion date | 28/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Not Specified |
| Target sample size at registration | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2010 |
| Date of final enrolment | 28/02/2012 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
School of Psychology
Bangor
LL57 2AS
United Kingdom
LL57 2AS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results of tool development | 01/06/2012 | Yes | No | |
| Results article | results of RCT | 01/01/2013 | Yes | No | |
| Protocol article | protocol | 25/06/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/08/2018: Publication reference added.
