Clinical trial NCT01943071: Effects and Costs of a Day Care Centre Program Designed for People With Dementia
Official title: Effects and Costs of a Day Care Centre Program Designed for People With Dementia - a 24 Month Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: dementia
day care centre programs
patients
family carers
cost-consequence analysis
Lead sponsor: Norwegian Centre for Ageing and Health
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2013-09-16
Enrollment: 261
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Admittance to nursing home care
timeFrame: 24 months
Secondary outcomes:
measure: Change in Quality of life for patients
timeFrame: 12 and 24 months
measure: Change in the patient's functioning of daily living
timeFrame: 12 and 24 months
measure: Change in depressive symptoms in patients
timeFrame: 12 and 24 months
measure: Change in patient's cognition
timeFrame: 12 and 24 months
measure: Change in neuropsychiatric symptoms in patients
timeFrame: 12 and 24 months
measure: Patients death
timeFrame: 24 months
measure: Change in level of burden in family carers
timeFrame: 12 and 24 months
measure: Change in family carers depressive symptoms
timeFrame: 12 and 24 months
measure: Change in quality of life for family carers
timeFrame: 12 and 24 months
measure: Differences in the use of health resources between the intervention group and the control group
timeFrame: 12 and 24 months
measure: Differences in quality adjusted life years between the intervention group and the control group
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Tønsberg
country: Norway
facility: Norwegian centre of Ageing and Health
Study officials:
affiliation: Norwegian Centre for Ageling and health
name: Knut Engedal, Professor
role: STUDY_CHAIR
References:
citation: 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.