Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Martin Orrell
ORCID ID
Contact details
University College London
Wolfson Building
Mental Health Sciences
48 Riding House St
London
W1W 7EY
United Kingdom
+44 (0)20 7679 9452
m.orrell@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
061627
Study information
Scientific title
A single blind randomised controlled study to identify and address the needs of older people with dementia in residential care
Acronym
Study hypothesis
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
Added 10/03/2009: London MREC gave approval on the 1st November 2000 (ref: MREC/00/2/77)
Study design
Single-blind cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/05/2000
Overall trial end date
31/07/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
238
Participant exclusion criteria
Does not meet with inclusion criteria
Recruitment start date
01/05/2000
Recruitment end date
31/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
W1W 7EY
United Kingdom
Funders
Funder type
Charity
Funder name
Wellcome Trust
Alternative name(s)
Wellcome
Funding Body Type
private sector organisation
Funding Body Subtype
international
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
Basic results (scientific)
Publication list
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16323258
Publication citations
-
Results
Hancock GA, Woods B, Challis D, Orrell M, The needs of older people with dementia in residential care., Int J Geriatr Psychiatry, 2006, 21, 1, 43-49, doi: 10.1002/gps.1421.