REspectful CAring for the AGitated Elderly (RECAGE)

July 30, 2019 updated by: Carlo Alberto Defanti, Fondazione Europea di Ricerca Biomedica Ferb Onlus

REspectful CAring for the AGitated Elderly. How to Best Meet the Needs of People With Dementia With Severe Behavioural Disturbances. Toward a Respectful and Cost-effective Model

The treatment of Behavioural and Psychological Symptoms of Dementia (BPSD) continue to raise difficult problems. Both the pharmacologic and non-pharmacologic therapies often fail to achieve the expected results. The aim of this study is to assess the short- and long-term efficacy of an intervention, the Special Care Unit for patients with BPSD (SCU-B), already implemented in some countries but not validated so far, as well as its cost-effectiveness

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Two cohorts of 250 patients each will be recruited by six clinical centres endowed with a SCU-B (one cohort) and six centres lacking this structure. The follow-up will last 3 years, during which patients will be visited every 6 months and submitted to a battery exploring the severity of the BPSD and the quality of life. All adverse events will be registered, as well as some anticipated occurrences (admissions to the general hospital for intercurrent diseases, admissions to a SCU-B pertaining to the clinical participating centre and, if any, admissions to a SCU-B not pertaining to the Consortium member, nursing home placement).

At the same time the quality of life of the primary caregivers will be measured, as well as their attitude toward dementia.

A cost-effectiveness analysis will be performed comparing the cohorts. Finally the time to the nursing home placement will be recorded and compared between the two cohorts

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Bruxelles, Belgium
  • France
      • Paris, France
        • Not yet recruiting
        • Assistance Publique - Hôpitaux de Paris
        • Contact:
  • Germany
      • Berlin, Germany
        • Recruiting
        • Charité - Universitätsmedizin Berlin
        • Contact:
    • Baden-Wurttenberg
      • Mannheim, Baden-Wurttenberg, Germany
        • Not yet recruiting
        • Zentralinstitut für seelische Gesundheit
        • Contact:
  • Greece
      • Thessaloníki, Greece
        • Recruiting
        • Aristotelio Panepistimio Thessalonikis (Greece)
        • Contact:
        • Contact:
          • Phone Number: +302310234239
  • Italy
    • BG
      • Bergamo, BG, Italy
        • Not yet recruiting
        • Cliniche Gavazzeni SpA
        • Contact:
      • Gazzaniga, BG, Italy, 24020
    • MN
      • Mantova, MN, Italy
        • Recruiting
        • Azienda Socio Sanitaria Territoriale di Mantova
        • Contact:
    • MO
      • Modena, MO, Italy
        • Not yet recruiting
        • Azienda Unità Sanitaria Locale di Modena
        • Contact:
    • PG
      • Perugia, PG, Italy
        • Not yet recruiting
        • Università degli Studi di Perugia
        • Contact:
  • Norway
  • Switzerland
      • Genève, Switzerland
        • Not yet recruiting
        • Université de Genève
        • Contact:

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

Sampling Method

Probability Sample

Study Population

The population studied is made by the outpatients with dementia referred to the memory clinics of 12 clinical centres located in seven European countries (Italy, Germany, France, Belgium, Greece, Switzerland, Norway)

Description

Inclusion Criteria:

  • diagnosis of primary dementia (DSM IV)
  • MMSE score ≤ 24
  • NPI global score ≥ 32/144
  • a caregiver (informal/family member or formal caregiver) who commits her/himself to accompany the patient along the three-year course of the study
  • living at home (nursing home residents are excluded).

Exclusion Criteria:

  • presence of uncontrolled medical disease potentially contributing to the cognitive decline and BPSD
  • concomitant psychiatric disorders or chronic alcoholism
  • concomitant diseases severe enough to reduce life expectancy < 6 months

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
care pathway with SCU-B
250 patients with dementia and behavioural and psychological symptoms of dementia (BPSD) followed up by six clinical centres with a Special Care Unit for BPSD (SCU-B)
Other: SCU-B
SCU-B is "a residential medical structure lying outside of a nursing home, in a general hospital or elsewhere, e.g. in a private hospital, where patients with BPSD are temporarily admitted when their behavioural disturbances are not amenable to control at home".
care pathway without SCU-B
250 patients with dementia and BPSD followed up by six clinical centres without SCU-B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of BPSD
Time Frame: baseline, 6, 12, 18, 24, 30, 36 months
Neuropsychiatric Inventory (NPI), range 0-144
baseline, 6, 12, 18, 24, 30, 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life of patients
Time Frame: baseline, 6, 12,18, 24, 30, 36 months
Quality of Life Alzheimer's Disease (QoL-AD), range 0-52
baseline, 6, 12,18, 24, 30, 36 months
quality of life of caregivers
Time Frame: baseline, 6, 12, 18, 24, 30, 36 months
Caregiver Burden Inventory (CBI), range 0-96
baseline, 6, 12, 18, 24, 30, 36 months
cost-effectiveness of SCU-B
Time Frame: baseline, 6, 12, 18, 24, 30, 36 months
Resource Utilisation in Dementia (RUD)
baseline, 6, 12, 18, 24, 30, 36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
delayed institutionalisation
Time Frame: until 3 years
Time to nursing home placement
until 3 years

Collaborators and Investigators

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

Sponsor

Fondazione Europea di Ricerca Biomedica Ferb Onlus

Collaborators

Mediolanum Cardio Research

Investigators

  • Study Director: Carlo A Defanti, M.D., Fondazione Europea di Ricerca Biomedica

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.

General Publications

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 (Actual)

April 19, 2018

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

April 15, 2018

First Posted (Actual)

April 25, 2018

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2020 Proposal, number: 779237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified participant data both for primary and secondary outcome measures will be made available

IPD Sharing Time Frame

Data will be available six months after study completion

IPD Sharing Access Criteria

Data access requests will be reviewed by an independent Data Safety Monitoring Board

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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