This trial is active, not recruiting.

Condition dementia
Treatment day care for patients with dementia
Sponsor Norwegian Centre for Ageing and Health
Collaborator The Research Council of Norway
Start date August 2013
End date June 2017
Trial size 261 participants
Trial identifier NCT01943071, NCAH-ECOD


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Day care for patients with dementia
day care for patients with dementia
Day care centres designed by the local authorities for patients with dementia
(No Intervention)
Care as usual

Primary Outcomes

Admittance to nursing home care
time frame: 24 months

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

Eligibility Criteria

Male or female participants at least 65 years old.

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

Additional Information

Official title Effects and Costs of a Day Care Centre Program Designed for People With Dementia - a 24 Month Controlled Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Norwegian Centre for Ageing and Health.