Comparison of Effectiveness and Costs of Post-diagnosis Treatment in Dementia (AD-Euro)

This study has been completed.
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Netherlands Alzheimer Foundation
VU University Medical Center
Maastricht University Medical Center
Karolinska Institutet
Stockholm Health Economics AB
Slingeland Hospital
Elkerliek Hospital
GGZ Oost Brabant
Rijnstate Hospital
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00554047
First received: November 5, 2007
Last updated: January 7, 2011
Last verified: August 2010
  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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554047

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
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Netherlands Alzheimer Foundation
VU University Medical Center
Maastricht University Medical Center
Karolinska Institutet
Stockholm Health Economics AB
Slingeland Hospital
Elkerliek Hospital
GGZ Oost Brabant
Rijnstate Hospital
Investigators
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 July 29, 2014