- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00554047
Comparison of Effectiveness and Costs of Post-diagnosis Treatment in Dementia (AD-Euro)
Effectiveness and Costs of Post-diagnosis Treatment in Dementia Coordinated by Multidisciplinary Memory Clinics in Comparison to Treatment Coordinated by General Practitioners
In the Netherlands a rapidly increasing number of multidisciplinary memory clinics (MMC) currently diagnose 25% of the patients with dementia. Following the diagnostic work-up, MMCs are increasingly involved in post-diagnosis treatment and coordination of care, which probably is very important for patients and caregivers, but also very time consuming and expensive. This study will focus on the important question whether this complex post-diagnosis treatment and care coordination, evaluated both on effectiveness and costs, should be carried out by MMCs (intervention) or by General Practitioners (GPs) (control) as pivot of delivery of health care for these patients.
Objectives: To determine MMCs' effectiveness and cost-effectiveness in post-diagnosis treatment and care-coordination for dementia-patients and their caregivers compared to the post-diagnosis treatment and care coordination by GPs.
Time schedule: 12 months for including patients and their caregivers and 12 months of follow-up.
Annex Study: Specifically for the Health Technology Assessment (HTA) methodology study the main study will be extended with some experimental proxy measurements and alternative measurement approaches.
The objective of this Annex-study is to explore the feasibility and validity of Health Related Quality of Life (HRQL) value measurement in dementia patients. And to study the characteristics of proxy rating in HRQL research in dementia and the suitability and validity of yielding HRQL measurements by proxy assessment. Furthermore to explore the validity, reliability, and feasibility of the EQ5D and EQ6D in dementia research (in patients and in/by proxies); response shift, and alternative (more simple) methods of HRQL measurement and validate the Dutch versions of the QOL-AD and the use of the CarerQol-7D in dementia research.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Amsterdam, Netherlands
- VU Medical Center, Alzheimer Centre
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Arnhem, Netherlands
- Alysis Zorgroep, Rijnstate Hospital, Department of Geriatrics
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Boxmeer, Netherlands
- GGZ Oost Brabant, Department of Geriatrics
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Doetinchem, Netherlands
- Slingeland Hospital, Department of Geriatrics
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Ede, Netherlands
- Hospital Gelderse Vallei, Department of Geriatrics
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Eindhoven, Netherlands
- Catharina hospital, Department of Geriatrics
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Helmond, Netherlands
- Elkerliek Hospital, Department of Geriatrics
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Maastricht, Netherlands
- University Hospital Maastricht, Alzheimer Centre
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Nijmegen, Netherlands
- University Medical Centre St Radboud, Alzheimer Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A patient with a new dementia diagnosis made at the MMC of the participating centre fulfilling DSM-IV-TR criteria with a CDR 0.5, 1 or 2
- Each patient has a caregiver
- Both patients and caregivers can provide informed consent for participation in the study
Exclusion Criteria:
- Life expectancy less than 1 year
- Living in a nursing home
- Already evaluated as being suitable for living in a nursing home
- Data collection impossible (e.g., due to severe visual/hearing/language impairment, mood disorder, or behavioral disturbances)
- The patient's general practitioner does not agree to participate
- Already participating in another study
- The patient visits the MMC for a second opinion
- Travel distance between MMC and patient's living address more than 50 kilometers
A definite indication for memory clinic follow up:
- A definite need for symptomatic drug treatment as judged by treating physician (e.g., Dementia with Lewy Bodies)
- A definite need for specialist guidance as judged by treating physician (e.g., Creutzfeldt-Jakob Disease, severe Frontotemporal Lobar Disease)
- A definite wish for symptomatic drug treatment by patient or caregiver
- A definite need for guidance from psychiatric services involved in the memory clinic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Multidisciplinary Memory Clinic
|
Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by Multidisciplinary Memory Clinics (MMCs)
|
Active Comparator: 2
General practitioner
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Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by general practitioners
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proxy-rated Health Related Quality of Life of the patient (cpQol-AD)
Time Frame: at 0, 6 and 12 months
|
at 0, 6 and 12 months
|
Informal caregivers burden (Sense of competence (SCQ))
Time Frame: at 0, 6 and 12 months
|
at 0, 6 and 12 months
|
Cost utility analysis (EQ 5D)
Time Frame: at 0, 6 and 12 months
|
at 0, 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Geriatric Depression Scale (GDS-15)
Time Frame: at 0, 6 and 12 months
|
at 0, 6 and 12 months
|
Care-related quality of life of informal caregivers (CarerQol-7D + CarerQol-VAS)
Time Frame: at 0, 6 and 12 months
|
at 0, 6 and 12 months
|
Quality of Live AD caregiver (cQoL-AD)
Time Frame: at 0, 6 and 12 months
|
at 0, 6 and 12 months
|
Neuro Psychiatric Inventory (NPI-Q)
Time Frame: at 0, 6 and 12 months
|
at 0, 6 and 12 months
|
Functional performance patient (IDDD)
Time Frame: at 0, 6 and 12 months
|
at 0, 6 and 12 months
|
Patients rated Health Related Quality of Life (pQol-AD)
Time Frame: at 0, 6 and 12 months
|
at 0, 6 and 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Prof. Dr. M. Olde Rikkert, MD PhD, University Medical Centre St Radboud, Nijmegen
Publications and helpful links
General Publications
- Meeuwsen E, Melis R, van der Aa G, Goluke-Willemse G, de Leest B, van Raak F, Scholzel-Dorenbos C, Verheijen D, Verhey F, Visser M, Wolfs C, Adang E, Olde Rikkert M. Cost-effectiveness of one year dementia follow-up care by memory clinics or general practitioners: economic evaluation of a randomised controlled trial. PLoS One. 2013 Nov 25;8(11):e79797. doi: 10.1371/journal.pone.0079797. eCollection 2013.
- Meeuwsen EJ, Melis RJ, Van Der Aa GC, Goluke-Willemse GA, De Leest BJ, Van Raak FH, Scholzel-Dorenbos CJ, Verheijen DC, Verhey FR, Visser MC, Wolfs CA, Adang EM, Olde Rikkert MG. Effectiveness of dementia follow-up care by memory clinics or general practitioners: randomised controlled trial. BMJ. 2012 May 15;344:e3086. doi: 10.1136/bmj.e3086.
- Meeuwsen EJ, German P, Melis RJ, Adang EM, Goluke-Willemse GA, Krabbe PF, de Leest BJ, van Raak FH, Scholzel-Dorenbos CJ, Visser MC, Wolfs CA, Vliek S, Rikkert MG. Cost-effectiveness of post-diagnosis treatment in dementia coordinated by Multidisciplinary Memory Clinics in comparison to treatment coordinated by general practitioners: an example of a pragmatic trial. J Nutr Health Aging. 2009 Mar;13(3):242-8. doi: 10.1007/s12603-009-0066-1.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADE 072510
- ZonMw 80-007022-98-07703
- ZonMw 945-07-7039
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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