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NCT Number: NCT01943071

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

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian centre of Ageing and Health

Tønsberg, 3103, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Day care for patients with dementia

Behavioral

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

Primary outcomes

  1. Admittance to nursing home care

    Time frame: 24 months

    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 outcomes

  1. Change in Quality of life for patients

    Time frame: 12 and 24 months

    The quality of life for patients as measured by Quality of Life - Alzheimer's Disease (QoL-AD)

  2. Change in the patient's functioning of daily living

    Time frame: 12 and 24 months

    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

  3. Change in depressive symptoms in patients

    Time frame: 12 and 24 months

    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

  4. Change in patient's cognition

    Time frame: 12 and 24 months

    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)

  5. Change in neuropsychiatric symptoms in patients

    Time frame: 12 and 24 months

    The change in Neuropsychiatric symptoms will be assessed using Neuropsychiatric Inventory Questionnaire (NPI-Q)

  6. Patients death

    Time frame: 24 months

    Number of patients that have died during 24 months will be registered

  7. Change in level of burden in family carers

    Time frame: 12 and 24 months

    Level of burden for family carers will be assessed by using the Relative's Stress Scale (RSS)

  8. Change in family carers depressive symptoms

    Time frame: 12 and 24 months

    The MADRS will be used to assess depressive symptoms in family carers

  9. Change in quality of life for family carers

    Time frame: 12 and 24 months

    QoL-AD will be used to assess quality of life in family carers

  10. Differences in the use of health resources between the intervention group and the control group

    Time frame: 12 and 24 months

    The use of health resources will be measured using the resource Utilization in Dementia scale (RUD)

  11. Differences in quality adjusted life years between the intervention group and the control group

    Time frame: 12 and 24 months

    A generic instrument, the EuroQol (EQ-5D) will be used to measure quality adjusted life years

Sponsors and collaborators

Lead sponsor

Norwegian Centre for Ageing and Health

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

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

Acronym: ECOD

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 16, 2013
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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