Comparison of Effectiveness and Costs of Post-diagnosis Treatment in Dementia (AD-Euro)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Dementia |
Other: Multidisciplinary Memory Clinic Other: General Practitioners |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Health Services Research |
| Official Title: | Effectiveness and Costs of Post-diagnosis Treatment in Dementia Coordinated by Multidisciplinary Memory Clinics in Comparison to Treatment Coordinated by General Practitioners |
- Proxy-rated Health Related Quality of Life of the patient (cpQol-AD) [ Time Frame: at 0, 6 and 12 months ] [ Designated as safety issue: No ]
- Informal caregivers burden (Sense of competence (SCQ)) [ Time Frame: at 0, 6 and 12 months ] [ Designated as safety issue: No ]
- Cost utility analysis (EQ 5D) [ Time Frame: at 0, 6 and 12 months ] [ Designated as safety issue: No ]
- Geriatric Depression Scale (GDS-15) [ Time Frame: at 0, 6 and 12 months ] [ Designated as safety issue: No ]
- Care-related quality of life of informal caregivers (CarerQol-7D + CarerQol-VAS) [ Time Frame: at 0, 6 and 12 months ] [ Designated as safety issue: No ]
- Quality of Live AD caregiver (cQoL-AD) [ Time Frame: at 0, 6 and 12 months ] [ Designated as safety issue: No ]
- Neuro Psychiatric Inventory (NPI-Q) [ Time Frame: at 0, 6 and 12 months ] [ Designated as safety issue: No ]
- Functional performance patient (IDDD) [ Time Frame: at 0, 6 and 12 months ] [ Designated as safety issue: No ]
- Patients rated Health Related Quality of Life (pQol-AD) [ Time Frame: at 0, 6 and 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 220 |
| Study Start Date: | December 2007 |
| Study Completion Date: | July 2010 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Multidisciplinary Memory Clinic
|
Other: 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
|
Other: General Practitioners
Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by general practitioners
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Netherlands | |
| VU Medical Center, Alzheimer Centre | |
| Amsterdam, Netherlands | |
| Alysis Zorgroep, Rijnstate Hospital, Department of Geriatrics | |
| Arnhem, Netherlands | |
| GGZ Oost Brabant, Department of Geriatrics | |
| Boxmeer, Netherlands | |
| Slingeland Hospital, Department of Geriatrics | |
| Doetinchem, Netherlands | |
| Hospital Gelderse Vallei, Department of Geriatrics | |
| Ede, Netherlands | |
| Catharina hospital, Department of Geriatrics | |
| Eindhoven, Netherlands | |
| Elkerliek Hospital, Department of Geriatrics | |
| Helmond, Netherlands | |
| University Hospital Maastricht, Alzheimer Centre | |
| Maastricht, Netherlands | |
| University Medical Centre St Radboud, Alzheimer Centre | |
| Nijmegen, Netherlands | |
| Principal Investigator: | Prof. Dr. M. Olde Rikkert, MD PhD | University Medical Centre St Radboud, Nijmegen |
More Information
No publications provided by Radboud University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00554047 History of Changes |
| Other Study ID Numbers: | ADE 072510, ZonMw 80-007022-98-07703, ZonMw 945-07-7039 |
| Study First Received: | November 5, 2007 |
| Last Updated: | January 7, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
Dementia Caregivers Costs and cost analysis Multicenter study |
Randomized controlled trial Quality Adjusted Life Years Quality of life Technology assessment, biomedical; Methods |
Additional relevant MeSH terms:
|
Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013