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Effects and Costs of a Day Care Centre Program Designed for People With Dementia

Effects and Costs of a Day Care Centre Program Designed for People With Dementia - a 24 Month Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01943071
Acronym
ECOD
Enrollment
261
Registered
2013-09-16
Start date
2013-08-01
Completion date
2017-12-31
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

dementia, day care centre programs, patients, family carers, cost-consequence analysis

Brief 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. 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.

Interventions

BEHAVIORALDay care for patients with dementia

Day care centres designed by the local authorities for patients with dementia

Sponsors

The Research Council of Norway
CollaboratorOTHER
Norwegian Centre for Ageing and Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Admittance to nursing home care24 monthsThe 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

Secondary

MeasureTime frameDescription
Change in the patient's functioning of daily living12 and 24 monthsThe 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
Change in depressive symptoms in patients12 and 24 monthsThe 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
Change in patient's cognition12 and 24 monthsPatient'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)
Change in neuropsychiatric symptoms in patients12 and 24 monthsThe change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)
Patients death24 monthsNumber of patients that have died during 24 months will be registered
Change in Quality of life for patients12 and 24 monthsThe quality of life for patients as measured by Quality of Life - Alzheimer's Disease (QoL-AD)
Change in family carers depressive symptoms12 and 24 monthsThe MADRS will be used to assess depressive symptoms in family carers
Change in quality of life for family carers12 and 24 monthsQoL-AD will be used to assess quality of life in family carers
Differences in the use of health resources between the intervention group and the control group12 and 24 monthsThe use of health resources will be measured using the resource Utilization in Dementia scale (RUD)
Differences in quality adjusted life years between the intervention group and the control group12 and 24 monthsA generic instrument, the EuroQol (EQ-5D) will be used to measure quality adjusted life years
Change in level of burden in family carers12 and 24 monthsLevel of burden for family carers will be assessed by using the Relative's Stress Scale (RSS)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026