NCT00147693

Brief Summary

The objective is to ascertain the potential efficiency of a systematic care programme for caregivers of dementia patients. The research questions are:

  • What are the costs and benefits of the Systematic Care Programme - Dementia (SCP-Dementia), as compared with usual care?
  • What are the effects on the quality of life of patients and informal caregivers (spouse, relative), as compared with usual care?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2005

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

October 1, 2008

Status Verified

September 1, 2008

Enrollment Period

8 months

First QC Date

September 6, 2005

Last Update Submit

September 30, 2008

Conditions

Keywords

DementiaAlzheimer DiseaseLewy-BodyCost*Community (dwelling)Caregiver(s)InstitutionalizationQuality of lifeRandomized Control TrailVascular dementia

Outcome Measures

Primary Outcomes (1)

  • Patients admissions to nursing homes or residential homes. This outcome is the most important input for the estimation of cost differences between the intervention group and controls.

    after one year follow-up period

Secondary Outcomes (1)

  • Secondary outcome for cost estimation is patient and caregiver related costs estimated by "Resource Utilisation in Dementia" (RUD), including time spent on caregiving, use of health care services by caregivers and patients and additional productivity.

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pairs of patients and their informal caregivers visiting the ambulatory mental health care service for the first time and treated by the professionals participating in the study

You may not qualify if:

  • Patients and caregivers not mastering the Dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Netherlands

Location

Related Publications (1)

  • Spijker A, Verhey F, Graff M, Grol R, Adang E, Wollersheim H, Vernooij-Dassen M. Systematic care for caregivers of people with dementia in the ambulatory mental health service: designing a multicentre, cluster, randomized, controlled trial. BMC Geriatr. 2009 Jun 7;9:21. doi: 10.1186/1471-2318-9-21.

MeSH Terms

Conditions

Dementia, VascularDementiaAlzheimer DiseaseLewy Body Disease

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathies

Study Officials

  • Myrra M Vernooij-Dassen, PhD

    Coordinator Alzheimer Centre UMC Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 7, 2005

Study Start

June 1, 2005

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

October 1, 2008

Record last verified: 2008-09

Locations