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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Norwegian Centre for Ageing and Health
ClinicalTrials.gov Identifier:
NCT01943071
First received: September 11, 2013
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Dementia
Behavioral: Day care for patients with dementia

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effects and Costs of a Day Care Centre Program Designed for People With Dementia - a 24 Month Controlled Study

Resource links provided by NLM:


Further study details as provided by Norwegian Centre for Ageing and Health:

Primary Outcome Measures:
  • Admittance to nursing home care [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    The change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)

  • Patients death [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Number of patients that have died during 24 months will be registered

  • Change in level of burden in family carers [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    Level of burden for family carers will be assessed by using the Relative's Stress Scale (RSS)

  • Change in family carers depressive symptoms [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    The MADRS will be used to assess depressive symptoms in family carers

  • Change in quality of life for family carers [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
    A generic instrument, the EuroQol (EQ-5D) will be used to measure quality adjusted life years


Estimated Enrollment: 400
Study Start Date: August 2013
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Day care for patients with dementia
Day care for patients with dementia
Behavioral: Day care for patients with dementia
Day care centres designed by the local authorities for patients with dementia
No Intervention: Care as usual
Care as usual

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943071

Locations
Norway
Norwegian centre of Ageing and Health
Tønsberg, Norway, 3103
Sponsors and Collaborators
Norwegian Centre for Ageing and Health
The Research Council of Norway
Investigators
Study Chair: Knut Engedal, Professor Norwegian Centre for Ageling and health
  More Information

No publications provided

Responsible Party: Norwegian Centre for Ageing and Health
ClinicalTrials.gov Identifier: NCT01943071     History of Changes
Other Study ID Numbers: NCAH-ECOD
Study First Received: September 11, 2013
Last Updated: April 1, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Norwegian Centre for Ageing and Health:
dementia
day care centre programs
patients
family carers
cost-consequence analysis

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014