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

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Other: Multidisciplinary Memory Clinic; Other: General Practitioners

• Registration Number: NCT00554047
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-06
• Study Start: 2007-12
• Study Completion: 2010-07
• Status Verified: 2010-08
• Last Update Submitted: 2011-01-07
• Last Update Posted: 2011-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Multidisciplinary Memory Clinic	Multidisciplinary Memory Clinic
2	General Practitioners	General practitioner

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Patients rated Health Related Quality of Life (pQol-AD)	at 0, 6 and 12 months

Trial Locations

Locations (9)

University Medical Centre St Radboud, Alzheimer Centre; 🇳🇱 Nijmegen, Netherlands

Catharina hospital, Department of Geriatrics; 🇳🇱 Eindhoven, Netherlands

Hospital Gelderse Vallei, Department of Geriatrics; 🇳🇱 Ede, Netherlands

Elkerliek Hospital, Department of Geriatrics; 🇳🇱 Helmond, Netherlands

Slingeland Hospital, Department of Geriatrics; 🇳🇱 Doetinchem, Netherlands

University Hospital Maastricht, Alzheimer Centre; 🇳🇱 Maastricht, Netherlands

GGZ Oost Brabant, Department of Geriatrics; 🇳🇱 Boxmeer, Netherlands

VU Medical Center, Alzheimer Centre; 🇳🇱 Amsterdam, Netherlands

Alysis Zorgroep, Rijnstate Hospital, Department of Geriatrics; 🇳🇱 Arnhem, Netherlands