NCT00554047

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2007

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2007

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

January 10, 2011

Status Verified

August 1, 2010

First QC Date

November 5, 2007

Last Update Submit

January 7, 2011

Conditions

Dementia

Keywords

DementiaCaregiversCosts and cost analysisMulticenter studyRandomized controlled trialQuality Adjusted Life YearsQuality of lifeTechnology assessment, biomedical; Methods

Outcome Measures

Primary Outcomes (3)

  • Proxy-rated Health Related Quality of Life of the patient (cpQol-AD)

    at 0, 6 and 12 months

  • Informal caregivers burden (Sense of competence (SCQ))

    at 0, 6 and 12 months

  • Cost utility analysis (EQ 5D)

    at 0, 6 and 12 months

Secondary Outcomes (6)

  • Geriatric Depression Scale (GDS-15)

    at 0, 6 and 12 months

  • Care-related quality of life of informal caregivers (CarerQol-7D + CarerQol-VAS)

    at 0, 6 and 12 months

  • Quality of Live AD caregiver (cQoL-AD)

    at 0, 6 and 12 months

  • Neuro Psychiatric Inventory (NPI-Q)

    at 0, 6 and 12 months

  • Functional performance patient (IDDD)

    at 0, 6 and 12 months

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Multidisciplinary Memory Clinic

Other: Multidisciplinary Memory Clinic

2

ACTIVE COMPARATOR

General practitioner

Other: General Practitioners

Interventions

Multidisciplinary Memory ClinicOTHER

Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by Multidisciplinary Memory Clinics (MMCs)

1
General PractitionersOTHER

Post-diagnosis treatment and coordination of care for patients with dementia and their informal caregivers delivered by general practitioners

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

VU Medical Center, Alzheimer Centre

Amsterdam, Netherlands

Location

Alysis Zorgroep, Rijnstate Hospital, Department of Geriatrics

Arnhem, Netherlands

Location

GGZ Oost Brabant, Department of Geriatrics

Boxmeer, Netherlands

Location

Slingeland Hospital, Department of Geriatrics

Doetinchem, Netherlands

Location

Hospital Gelderse Vallei, Department of Geriatrics

Ede, Netherlands

Location

Catharina hospital, Department of Geriatrics

Eindhoven, Netherlands

Location

Elkerliek Hospital, Department of Geriatrics

Helmond, Netherlands

Location

University Hospital Maastricht, Alzheimer Centre

Maastricht, Netherlands

Location

University Medical Centre St Radboud, Alzheimer Centre

Nijmegen, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 24282511DERIVED

  • 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.

    PMID: 22589500DERIVED

  • 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.

    PMID: 19262961DERIVED

MeSH Terms

Conditions

Dementia

Interventions

General Practitioners

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhysiciansHealth PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Prof. Dr. M. Olde Rikkert, MD PhD

    University Medical Centre St Radboud, Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 6, 2007

Study Start

December 1, 2007

Study Completion

July 1, 2010

Last Updated

January 10, 2011

Record last verified: 2010-08

Locations

NL(9)