NCT01943071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 10, 2020

Status Verified

February 1, 2020

Enrollment Period

4.3 years

First QC Date

September 11, 2013

Last Update Submit

February 7, 2020

Conditions

Keywords

dementiaday care centre programspatientsfamily carerscost-consequence analysis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Change in Quality of life for patients

    12 and 24 months

  • Change in the patient's functioning of daily living

    12 and 24 months

  • Change in depressive symptoms in patients

    12 and 24 months

  • Change in patient's cognition

    12 and 24 months

  • Change in neuropsychiatric symptoms in patients

    12 and 24 months

  • +6 more secondary outcomes

Study Arms (2)

Day care for patients with dementia

EXPERIMENTAL

Day care for patients with dementia

Behavioral: Day care for patients with dementia

Care as usual

NO INTERVENTION

Care as usual

Interventions

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

Day care for patients with dementia

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having applied for nursing home placement
  • Suffering from a serious co-morbid physical disorder with life expectancy less than six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian centre of Ageing and Health

Tønsberg, 3103, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dementia

Interventions

Day Care, Medical

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Knut Engedal, Professor

    Norwegian Centre for Ageling and health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2013

First Posted

September 16, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 31, 2017

Last Updated

February 10, 2020

Record last verified: 2020-02

Locations