- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01943071
Effects and Costs of a Day Care Centre Program Designed for People With Dementia (ECOD)
February 7, 2020 updated by: Norwegian Centre for Ageing and Health
Effects and Costs of a Day Care Centre Program Designed for People With Dementia - a 24 Month Controlled Study
Attending day care centres with programs specifically designed for patients with dementia is believed to postpone admittance to nursing home as well as increase quality of life and well-being for both patients and their family caregivers.
We aim to investigate to what degree attendance in day care centres with programs for people with dementia is effective for patient and their caregivers whilst also cost efficient for society.
The study consists of a quasi-experimental trial with comparison group.
400 patients with dementia, along with a family caregiver, will be included in the trial.
Effects will be measured at baseline, after one and two years.
Data collection will be made at three levels; at patient level with measures of cognition, depression, quality of life, functioning in activities in daily living, neuropsychiatric symptoms and death; at caregiver level with measures of depression, level of burden and quality of life; and at societal level with measures of nursing home admittance, hospital stays and use of other health resources.
Additionally,a qualitative interview study will include 20 dyads from the main trial.
The main focus will be on how attending day care centre programs for patients with dementia affect the lives of both patients and caregivers.
Five of these dyads will be followed closely throughout the participation period to be used as case examples.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A quasi experimental trial with a comparison group will be performed to evaluate the effect of the day care centre programs by comparing results from municipalities with (intervention group) and without (comparison group) a day care centre program designed for people with dementia using standardized assessment tools.
Furthermore, a survey will be used to explore the communication and co-operation between the professional staff at the day care centre, the patients and the family carers by administering questionnaires to all three parties.
Only patients with mild degree of dementia will be asked to participate in the questionnaire.
Finally, qualitative interviews will be made with 20 dyads of patients and family carers to collect their in depth experience with the day care centre program.
Five of these patients and their family carers will be followed closely as case examples for two years.
Study Type
Interventional
Enrollment (Actual)
261
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Tønsberg, Norway, 3103
- Norwegian centre of Ageing and Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age of 65 years or more and living at home
- Patients in the day care centre group must have attended the centre for at least four weeks and have been there no longer than nine months
- Dementia of either Alzheimer's type, vascular dementia, dementia with Lewy bodies/Parkinson's disease or a mixture of these types of dementias
- Capacity to give informed consent as judged by the professional caregivers
- A Mini Mental Status Examination (MMSE) score of ≥15
- Having a family carer willing to participate, who see the patients personally at least once a week
- Attending the day care centre program at least twice a week
Exclusion Criteria:
- Having applied for nursing home placement
- Suffering from a serious co-morbid physical disorder with life expectancy less than six months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Day care for patients with dementia
|
Day care centres designed by the local authorities for patients with dementia
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No Intervention: Care as usual
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Admittance to nursing home care
Time Frame: 24 months
|
The number of patients admitted to nursing home care during a period of 24 months will be the primary outcome for the effect and the cost-consequence analysis
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of life for patients
Time Frame: 12 and 24 months
|
The quality of life for patients as measured by Quality of Life - Alzheimer's Disease (QoL-AD)
|
12 and 24 months
|
Change in the patient's functioning of daily living
Time Frame: 12 and 24 months
|
The Physical self-Maintenance Scale and Instrumental Activities of Daily Living Scale will be used to assess change in the patient's function of daily living
|
12 and 24 months
|
Change in depressive symptoms in patients
Time Frame: 12 and 24 months
|
The change in depressive symptoms will be assessed by Montgomery Asberg Depression Rating Scale (MADRS)by interviews with both patient and family carer and the Cornell Scale for Depression in Dementia (CSDD) by interviews with family carers and a professional caregiver
|
12 and 24 months
|
Change in patient's cognition
Time Frame: 12 and 24 months
|
Patient's cognition will be assessed using the Mini Mental State Examination (MMSE) the Clock Drawing Test (CDT), the Trail Making Test A (TMT-A)and the 10 word test of the Consortium to Establish a Registry in Alzheimer's Disease (CERAD)
|
12 and 24 months
|
Change in neuropsychiatric symptoms in patients
Time Frame: 12 and 24 months
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The change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)
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12 and 24 months
|
Patients death
Time Frame: 24 months
|
Number of patients that have died during 24 months will be registered
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24 months
|
Change in level of burden in family carers
Time Frame: 12 and 24 months
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Level of burden for family carers will be assessed by using the Relative's Stress Scale (RSS)
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12 and 24 months
|
Change in family carers depressive symptoms
Time Frame: 12 and 24 months
|
The MADRS will be used to assess depressive symptoms in family carers
|
12 and 24 months
|
Change in quality of life for family carers
Time Frame: 12 and 24 months
|
QoL-AD will be used to assess quality of life in family carers
|
12 and 24 months
|
Differences in the use of health resources between the intervention group and the control group
Time Frame: 12 and 24 months
|
The use of health resources will be measured using the resource Utilization in Dementia scale (RUD)
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12 and 24 months
|
Differences in quality adjusted life years between the intervention group and the control group
Time Frame: 12 and 24 months
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A generic instrument, the EuroQol (EQ-5D) will be used to measure quality adjusted life years
|
12 and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Knut Engedal, Professor, Norwegian Centre for Ageling and health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2013
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
September 11, 2013
First Submitted That Met QC Criteria
September 11, 2013
First Posted (Estimate)
September 16, 2013
Study Record Updates
Last Update Posted (Actual)
February 10, 2020
Last Update Submitted That Met QC Criteria
February 7, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCAH-ECOD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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