Comparison of Effectiveness and Costs of Post-diagnosis Treatment in Dementia

Dementia Clinical Trial

— AD-Euro  

Official title:

Effectiveness and Costs of Post-diagnosis Treatment in Dementia Coordinated by Multidisciplinary Memory Clinics in Comparison to Treatment Coordinated by General Practitioners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00554047
• Other study ID #: ADE 072510
• Secondary ID: ZonMw 80-007022-
• Status: Completed
• Phase: N/A
• First received: November 5, 2007
• Last updated: January 7, 2011
• Start date: December 2007
• Est. completion date: July 2010

Study information

• Verified date: August 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Dementia

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (11)

Lead Sponsor	Collaborator
Radboud University	Elkerliek Hospital, GGZ Oost Brabant, Karolinska Institutet, Maastricht University Medical Center, Netherlands Alzheimer Foundation, Rijnstate Hospital, Slingeland Hospital, Stockholm Health Economics AB, VU University Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proxy-rated Health Related Quality of Life of the patient (cpQol-AD)		at 0, 6 and 12 months	No
Primary	Informal caregivers burden (Sense of competence (SCQ))		at 0, 6 and 12 months	No
Primary	Cost utility analysis (EQ 5D)		at 0, 6 and 12 months	No
Secondary	Geriatric Depression Scale (GDS-15)		at 0, 6 and 12 months	No
Secondary	Care-related quality of life of informal caregivers (CarerQol-7D + CarerQol-VAS)		at 0, 6 and 12 months	No
Secondary	Quality of Live AD caregiver (cQoL-AD)		at 0, 6 and 12 months	No
Secondary	Neuro Psychiatric Inventory (NPI-Q)		at 0, 6 and 12 months	No
Secondary	Functional performance patient (IDDD)		at 0, 6 and 12 months	No
Secondary	Patients rated Health Related Quality of Life (pQol-AD)		at 0, 6 and 12 months	No