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

January 7, 2011 updated by: Radboud University Medical Center

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

Completed

Conditions

Study Type

Interventional

Enrollment (Anticipated)

220

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

      • Amsterdam, Netherlands
        • VU Medical Center, Alzheimer Centre
      • Arnhem, Netherlands
        • Alysis Zorgroep, Rijnstate Hospital, Department of Geriatrics
      • Boxmeer, Netherlands
        • GGZ Oost Brabant, Department of Geriatrics
      • Doetinchem, Netherlands
        • Slingeland Hospital, Department of Geriatrics
      • Ede, Netherlands
        • Hospital Gelderse Vallei, Department of Geriatrics
      • Eindhoven, Netherlands
        • Catharina hospital, Department of Geriatrics
      • Helmond, Netherlands
        • Elkerliek Hospital, Department of Geriatrics
      • Maastricht, Netherlands
        • University Hospital Maastricht, Alzheimer Centre
      • Nijmegen, Netherlands
        • University Medical Centre St Radboud, Alzheimer Centre

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:

  • 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

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: 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
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

This is where you will find people and organizations involved with this study.

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

December 1, 2007

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

November 5, 2007

First Submitted That Met QC Criteria

November 5, 2007

First Posted (Estimate)

November 6, 2007

Study Record Updates

Last Update Posted (Estimate)

January 10, 2011

Last Update Submitted That Met QC Criteria

January 7, 2011

Last Verified

August 1, 2010

More Information

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.

Clinical Trials on Dementia

Clinical Trials on Multidisciplinary Memory Clinic

3
Subscribe