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

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Day care for patients with dementia
Sponsored by
Norwegian Centre for Ageing and Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia focused on measuring dementia, day care centre programs, patients, family carers, cost-consequence analysis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norwegian centre of Ageing and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Day care for patients with dementia

Care as usual

Arm Description

Day care for patients with dementia

Care as usual

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Quality of life for patients
The quality of life for patients as measured by Quality of Life - Alzheimer's Disease (QoL-AD)
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
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
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)
Change in neuropsychiatric symptoms in patients
The change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)
Patients death
Number of patients that have died during 24 months will be registered
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)
Change in family carers depressive symptoms
The MADRS will be used to assess depressive symptoms in family carers
Change in quality of life for family carers
QoL-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 group
The 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 group
A generic instrument, the EuroQol (EQ-5D) will be used to measure quality adjusted life years

Full Information

First Posted
September 11, 2013
Last Updated
February 7, 2020
Sponsor
Norwegian Centre for Ageing and Health
Collaborators
The Research Council of Norway
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1. Study Identification

Unique Protocol Identification Number
NCT01943071
Brief Title
Effects and Costs of a Day Care Centre Program Designed for People With Dementia
Acronym
ECOD
Official Title
Effects and Costs of a Day Care Centre Program Designed for People With Dementia - a 24 Month Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2013 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian Centre for Ageing and Health
Collaborators
The Research Council of Norway

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
dementia, day care centre programs, patients, family carers, cost-consequence analysis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Day care for patients with dementia
Arm Type
Experimental
Arm Description
Day care for patients with dementia
Arm Title
Care as usual
Arm Type
No Intervention
Arm Description
Care as usual
Intervention Type
Behavioral
Intervention Name(s)
Day care for patients with dementia
Intervention Description
Day care centres designed by the local authorities for patients with dementia
Primary Outcome Measure Information:
Title
Admittance to nursing home care
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Change in Quality of life for patients
Description
The quality of life for patients as measured by Quality of Life - Alzheimer's Disease (QoL-AD)
Time Frame
12 and 24 months
Title
Change in the patient's functioning of daily living
Description
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
Time Frame
12 and 24 months
Title
Change in depressive symptoms in patients
Description
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
Time Frame
12 and 24 months
Title
Change in patient's cognition
Description
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)
Time Frame
12 and 24 months
Title
Change in neuropsychiatric symptoms in patients
Description
The change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)
Time Frame
12 and 24 months
Title
Patients death
Description
Number of patients that have died during 24 months will be registered
Time Frame
24 months
Title
Change in level of burden in family carers
Description
Level of burden for family carers will be assessed by using the Relative's Stress Scale (RSS)
Time Frame
12 and 24 months
Title
Change in family carers depressive symptoms
Description
The MADRS will be used to assess depressive symptoms in family carers
Time Frame
12 and 24 months
Title
Change in quality of life for family carers
Description
QoL-AD will be used to assess quality of life in family carers
Time Frame
12 and 24 months
Title
Differences in the use of health resources between the intervention group and the control group
Description
The use of health resources will be measured using the resource Utilization in Dementia scale (RUD)
Time Frame
12 and 24 months
Title
Differences in quality adjusted life years between the intervention group and the control group
Description
A generic instrument, the EuroQol (EQ-5D) will be used to measure quality adjusted life years
Time Frame
12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Knut Engedal, Professor
Organizational Affiliation
Norwegian Centre for Ageling and health
Official's Role
Study Chair
Facility Information:
Facility Name
Norwegian centre of Ageing and Health
City
Tønsberg
ZIP/Postal Code
3103
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
30445937
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.
Results Reference
derived

Learn more about this trial

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

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