DementiaECODNCT01943071
Effects and Costs of a Day Care Centre Program Designed for People With Dementia
A study testing Day care for patients with dementia in people with Dementia, run by Norwegian Centre for Ageing and Health at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Day care for patients with dementia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 siteNorway
- Study dates
- 1 Aug 2013to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Having applied for nursing home placement
- Suffering from a serious co-morbid physical disorder with life expectancy less than six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia
- Being tested
- Day care for patients with dementia
- Keywords
- dementia, day care centre programs, patients, family carers, cost-consequence analysis
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day care for patients with dementiaBehavioural
Day care centres designed by the local authorities for patients with dementia
| Study group | Role | What they receive |
|---|---|---|
| Day care for patients with dementia | Experimental | Day care for patients with dementia Receives: Behavioral: Day care for patients with dementia |
| Care as usual | No intervention | Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admittance to nursing home care
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
Measured: 24 months
Secondary outcomes (11)
Change in Quality of life for patients
The quality of life for patients as measured by Quality of Life - Alzheimer's Disease (QoL-AD)
Measured: 12 and 24 months
Change in the patient's functioning of daily living
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
Measured: 12 and 24 months
Change in depressive symptoms in patients
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
Measured: 12 and 24 months
Change in patient's cognition
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)
Measured: 12 and 24 months
Change in neuropsychiatric symptoms in patients
The change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)
Measured: 12 and 24 months
Patients death
Number of patients that have died during 24 months will be registered
Measured: 24 months
Change in level of burden in family carers
Level of burden for family carers will be assessed by using the Relative's Stress Scale (RSS)
Measured: 12 and 24 months
Change in family carers depressive symptoms
The MADRS will be used to assess depressive symptoms in family carers
Measured: 12 and 24 months
Change in quality of life for family carers
QoL-AD will be used to assess quality of life in family carers
Measured: 12 and 24 months
Differences in the use of health resources between the intervention group and the control group
The use of health resources will be measured using the resource Utilization in Dementia scale (RUD)
Measured: 12 and 24 months
Differences in quality adjusted life years between the intervention group and the control group
A generic instrument, the EuroQol (EQ-5D) will be used to measure quality adjusted life years
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study start1 Aug 2013
- Primary completion1 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Centre for Ageing and Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Knut Engedal, Professor, Study chair, Norwegian Centre for Ageling and health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943071
- Sponsor's protocol ID
- NCAH-ECOD
- Acronym
- ECOD
- Status last verified
- Feb 2020
- First submitted
- 11 Sep 2013
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rokstad AMM, Engedal K, Kirkevold O, Benth JS, Selbaek G. The impact of attending day care designed for home-dwelling people with dementia on nursing home admission: a 24-month controlled study. BMC Health Serv Res. 2018 Nov 16;18(1):864. doi: 10.1186/s12913-018-3686-5.
PubMed 30445937
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Costs of a Day Care Centre Program Designed for People With Dementia - a 24 Month Controlled Study
- ClinicalTrials.gov ID
- NCT01943071
- Acronym / sponsor ID
- ECOD / NCAH-ECOD
- Conditions
- Dementia
- Keywords
- dementia, day care centre programs, patients, family carers, cost-consequence analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Norwegian Centre for Ageing and HealthUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day care for patients with dementia | Experimental | Behavioral: Day care for patients with dementiaDay care for patients with dementia |
| Care as usual | No intervention | –Care as usual |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Having applied for nursing home placement
- Suffering from a serious co-morbid physical disorder with life expectancy less than six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Day care for patients with dementiaDay care centres designed by the local authorities for patients with dementia | Behavioural | Day care for patients with dementia |
Primary outcome
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
11 secondary outcomes
Change in Quality of life for patients
Time frame: 12 and 24 months
Change in the patient's functioning of daily living
Time frame: 12 and 24 months
Change in depressive symptoms in patients
Time frame: 12 and 24 months
Change in patient's cognition
Time frame: 12 and 24 months
Change in neuropsychiatric symptoms in patients
Time frame: 12 and 24 months
Patients death
Time frame: 24 months
Change in level of burden in family carers
Time frame: 12 and 24 months
Change in family carers depressive symptoms
Time frame: 12 and 24 months
Change in quality of life for family carers
Time frame: 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
Differences in quality adjusted life years between the intervention group and the control group
Time frame: 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Derived from this study: PubMed 30445937Rokstad AMM, Engedal K, Kirkevold O, Benth JS, Selbaek G. The impact of attending day care designed for home-dwelling people with dementia on nursing home admission: a 24-month controlled study. BMC Health Serv Res. 2018 Nov 16;18(1):864. doi: 10.1186/s12913-018-3686-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Knut Engedal, Professor study chair
Norwegian Centre for Ageling and health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Day care for patients with dementia in people with Dementia, run by Norwegian Centre for Ageing and Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admittance to nursing home care (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01943071, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.