Improving the needs of people with dementia in care homes
| ISRCTN | ISRCTN01712819 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01712819 |
| Secondary identifying numbers | 061627 |
- Submission date
- 14/10/2005
- Registration date
- 14/10/2005
- Last edited
- 05/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Dementia is a term given to a group of conditions that involve the gradual decline of a person’s mental faculties. People with dementia have difficulties with mental processes such as memory, language, reasoning and identifying people and objects, which become progressively worst over time. This can make it very difficult to deal with daily life and so many sufferers are often placed in nursing homes so that they can receive round-the-clock care. There are many facilities in nursing homes aiming to help residents with a range of difficulties, however the particular needs of patients with dementia are still not really known and these unmet needs could lead to a poorer quality of life. The aim of this study is to try to identify the unmet needs of nursing home residents with dementia.
Who can participate?
Nursing home residents over 60 years old who are showing signs of dementia.
What does the study involve?
Participating nursing homes are randomly allocated to one of two groups. Residents attending nursing homes in the first group provide feedback about their specific needs, which are discussed in weekly hour-long sessions with a research nurse or clinical psychologist, over a period of 20 weeks. This information is then used to try and develop a way of ensuring that the needs of these residents are met. Residents attending nursing homes in the second group continue as normal for the 20 weeks of the study. At the end of the study, residents complete a number of questionnaires so that their needs and quality of life can be assessed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University College London (UK)
When is the study starting and how long is it expected to run for?
May 2000 to July 2014
Who is funding the study?
Wellcome Trust (grant reference: 061627) (UK)
Who is the main contact?
Professor Martin Orrell
Contact information
Scientific
University College London
Wolfson Building
Mental Health Sciences
48 Riding House St
London
W1W 7EY
United Kingdom
| Phone | +44 (0)20 7679 9452 |
|---|---|
| m.orrell@ucl.ac.uk |
Study information
| Study design | Single-blind cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A single blind randomised controlled study to identify and address the needs of older people with dementia in residential care |
| Study objectives | 1. To compare the met and unmet needs of dementia sufferers in residential care from a range of areas 2. To investigate the relationship between costs of care, quality of life and met and unmet needs 3. To determine and cost appropriate interventions to meet unmet needs and provide systematic feedback on the needs and suggested interventions to the care staff for a 50% sample 4. To follow up all dementia sufferers six months later and examine whether systematic feedback of needs resulted in interventions being carried out, the actual cost of the individual interventions and the costs of other outcomes (e.g. hospital admission) As of 10/03/2009 this record was updated to include an amended end date; the initial end date at the time of registration was 31/05/2005. All other changes can be found under the relevant field with the above update date. |
| Ethics approval(s) | Added 10/03/2009: London MREC gave approval on the 1st November 2000 (ref: MREC/00/2/77) |
| Health condition(s) or problem(s) studied | Dementia |
| Intervention | Single-blind cluster randomised controlled trial involving 238 people with dementia living in residential care. 50% of the residential care homes (12 of 24) received feedback on needs of residents and one hour per week over 20 weeks liaison by a research nurse or clinical psychologist. |
| Intervention type | Other |
| Primary outcome measure | 1. Camberwell Assessment of Need for the Elderly 2. Quality of Life in Dementia (QoL-AD) |
| Secondary outcome measures | Added 10/03/2009: Quality of life at four months. |
| Overall study start date | 01/05/2000 |
| Completion date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 238 |
| Key inclusion criteria | Inclusion of residents into the study was completed using the following procedure: 1. All residents over 60 years old, either sex, who showed signs of dementia 2. Had resided permanently in the home for the past month 3. Had intentions of staying 4. Were identified by the home manager and the researcher using the National Institute of Social Workers (NISW) Noticeable Problems checklist (Levin, Sinclair, & Gorbach, 1989) The list of residents with probable and possible dementia was then further screened by the researcher to ensure they had a diagnosis of dementia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]; APA, 1994) using care home notes and clinical assessments. Those with a DSM-IV diagnosis of dementia were entered into the randomisation procedure. |
| Key exclusion criteria | Does not meet with inclusion criteria |
| Date of first enrolment | 01/05/2000 |
| Date of final enrolment | 31/07/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
W1W 7EY
United Kingdom
Sponsor information
University/education
Mental Health Services
Wolfson Building
48 Riding House Street
London
W1W 7EY
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Charity
Private sector organisation / International organizations
- Location
- United Kingdom
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? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2006 | Yes | No |
Editorial Notes
05/02/2016: Plain English summary added, verifying study status with principal investigator.
