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

Dementia Clinical Trial

— ECOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943071
• Other study ID #: NCAH-ECOD
• Status: Completed
• Phase: N/A
• Start date: August 1, 2013
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2020
• Source: Norwegian Centre for Ageing and Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: December 31, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia

Intervention

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

Locations

Country	Name	City	State
Norway	Norwegian centre of Ageing and Health	Tønsberg

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian Centre for Ageing and Health	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 months
Secondary	Change in Quality of life for patients	The quality of life for patients as measured by Quality of Life - Alzheimer's Disease (QoL-AD)	12 and 24 months
Secondary	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	12 and 24 months
Secondary	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	12 and 24 months
Secondary	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)	12 and 24 months
Secondary	Change in neuropsychiatric symptoms in patients	The change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)	12 and 24 months
Secondary	Patients death	Number of patients that have died during 24 months will be registered	24 months
Secondary	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)	12 and 24 months
Secondary	Change in family carers depressive symptoms	The MADRS will be used to assess depressive symptoms in family carers	12 and 24 months
Secondary	Change in quality of life for family carers	QoL-AD will be used to assess quality of life in family carers	12 and 24 months
Secondary	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)	12 and 24 months
Secondary	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	12 and 24 months