- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00147693
Systematic Care for Informal Caregivers of Dementia Patients: An Efficient Approach?
September 30, 2008 updated by: Radboud University Medical Center
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?
Study Overview
Status
Completed
Detailed Description
A major challenge for future health care is the care for dementia patients and their informal caregivers.
In usual care, the problems of caregivers often remain invisible until a crisis occurs.
This inhibition is partly the result of informal caregivers paying scant attention to their own problems.
Another reason is that professionals may not know how to support informal caregivers pro-actively (Van Hout et al., 2000).
Therefore the family support programme (Bengtson, 1985: Vernooij et al., 2000) has been transformed into a Systematic Care Programme (SCP-Dementia).
The reasons for choosing and studying the efficiency of this programme are the potential to diagnose and treat problems systematically, to cover a wide range of individual problems, its flexibility in connecting interventions to these problems, its suitability for pro-activity and the positive effects of the programme found in our previous study (Vernooij et al., 2000).
To study its efficiency a cluster randomised controlled trial design will be used.
Randomisation will take place in each of three participating regions.
Professionals in the ambulatory mental health care services (psychologists and social psychiatric nurses) will be randomly assigned to either the intervention group or the control group before the recruitment of patients and informal caregivers.
The study population consists of pairs of patients and their informal caregivers visiting the ambulatory mental health care service for the first time.
The intervention is the training in SCP-Dementia and its subsequent use.
SCP-Dementia consists of an assessment of the caregiver's sense of competence and suggestions on how to deal with deficiencies in competence.
The follow-up period is one year.
The primary outcome is patients´ admissions to nursing homes or residential homes.
The secondary outcome is quality of life.
Caregivers´ quality of life is assessed by sense of competence (SCQ), depression (CES-D) and physical quality of life (EuroQol).
Patients´ quality of life by behavioral problems is assessed by the NPI-Q and the QOL-AD-Scale.
The difference in proposed effect was based on previous research in which 14% of the patients in the intervention group and 28% in the control group were institutionalized (Vernooij-Dassen, 1993;1995).
To detect a 50% reduction in institutionalization rates with 80% power at the two sided significance level of 0.05, 132 patient-caregiver dyads would be needed for each of the intervention and control arm.
We inflated this sample size by a design effect of 1.15 to 152 dyads per trial arm to allow for correlation of dyads within the same cluster (i.e.
professional), assuming an average cluster size of four and an intracluster correlation coefficient of 0.05.
Assuming a 25% dropout rate of patient-caregiver dyads, the study needed an final enrolment of 190 dyads in each trial arm.
The economic evaluation is a cost-effectiveness analysis regarding a societal perspective.
In the economic evaluation both costs and effects will be monetarized and consequently will result in a net benefit.
Study Type
Interventional
Enrollment (Actual)
304
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Nijmegen, Netherlands
- Radboud University Nijmegen Medical Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients and caregivers not mastering the Dutch language
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: after one year follow-up period
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after one year follow-up period
|
Secondary Outcome Measures
Outcome Measure |
---|
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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Myrra M Vernooij-Dassen, PhD, Coordinator Alzheimer Centre UMC Nijmegen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
February 1, 2006
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
September 6, 2005
First Submitted That Met QC Criteria
September 6, 2005
First Posted (Estimate)
September 7, 2005
Study Record Updates
Last Update Posted (Estimate)
October 1, 2008
Last Update Submitted That Met QC Criteria
September 30, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurocognitive Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Tauopathies
- Intracranial Arterial Diseases
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Dementia
- Alzheimer Disease
- Lewy Body Disease
- Dementia, Vascular
Other Study ID Numbers
- SCAD
- ZonMw grant no 945-04-152
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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