Resource Use and Disease Course in Dementia (REDIC)

Sponsor
Sykehuset Innlandet HF (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01920100
Collaborator
Norwegian Directorate of Health (Other), King's College London (Other), Karolinska Institutet (Other), Oslo University Hospital (Other), University Hospital, Akershus (Other), Helse Midt-Norge (Other), Norwegian University of Science and Technology (Other), University of Bergen (Other), Norwegian Centre for Ageing and Health (Other)
2,800
3
153
933.3
6.1

Study Details

Study Description

Brief Summary

This project is based on a three-year program that aims to improve the knowledge of the socioeconomic consequences of dementia in Norway. By including patients with and without dementia in four different cohorts (from nursing homes, from memory clinics, home-dwelling persons with dementia and elderly persons without dementia), the project's aim is to describe tha course of dementia, the economical cost of dementia and to look into possible risk factors for dementia.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Resource Use and Disease Course in Dementia (REDIC)
    Study Start Date :
    Apr 1, 2009
    Actual Primary Completion Date :
    Jan 1, 2015
    Anticipated Study Completion Date :
    Jan 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Memory clinic

    People visiting a memory clinic at Ullevål University Hospital, St Olav Hospital or Innlandet Hospital Trust (n=400). The patients will be assessed three times over a three-year follow-up. Baseline inclusion started in January 2010. The final assessments will take place in spring 2014.

    Nursing homes

    People admitted to a nursing home recruited from municipalities in Hedmark, Oppland, Nord-Trøndelag and Bergen (n=1000). Baseline assessments take place when the person is admitted to the nursing home. The patients will be assessed every six months over a three-year follow-up period. The first participant was included in March 2012, and baseline inclusion will be completed in December 2013.

    In-home care

    People 70 years of age or older receiving in-home care recruited from municipalities in Hedmark, Oppland, Oslo, Østfold and Buskerud (n=995). The patients will be assessed three times over a three-year follow-up period. Baseline inclusion started in April 2009 and the final assessments will take place in December 2013.

    People without dementia

    People without dementia recruited from Nord-Trøndelag, Drammen and Oslo (n=400). The participants will be assessed three times over a three-year follow-up period. Baseline inclusion will take place in autumn 2012 and the last follow-up will take place in autumn 2015.

    Outcome Measures

    Primary Outcome Measures

    1. Cost of dementia [3 years]

      The cost of dementia is assessed with the Resource Utilization in Dementia (RUD) (Wimo et al. 2009), for a period of three years for all the four cohorts. The nursing home cohort is assessed at baseline and every 6 month for three years, the other three cohorts are assessed three times over a three-year follow up period.

    Secondary Outcome Measures

    1. The course of neuropsychiatric symptoms [3 years]

      The course of neuropsychiatric symptoms (depression, anxiety, psychosis, aggression, apathy, and cognition, are assessed with standardized assessment Tools. The nursing home cohort is assessed at baseline and every 6 month for three years, the other three cohorts are assessed three times over a three-year follow up period.

    2. Quality of Life in persons admitted to nursing homes [3 years]

      Quality of Life is assessed with standardized assessment Tools. The nursing home cohort is assessed at baseline and every 6 month for three years, the other three cohorts are assessed three times over a three-year follow up period.

    3. Prescription of medication [3 years]

      Prescription of medication is recorded at baseline, and the amount of medication used is recorded throughout the study period. The nursing home cohort is assessed at baseline and every 6 month for three years, the other three cohorts are assessed three times over a three-year follow up period.

    4. DNA polymorphism [At baseline]

      DNA samples are collected for the nursing home cohort, and they are assessed for genetic polymorphism previous associated with dementia. The results are used as covariates in the analyses of the course of the symptoms and to look for risk factors for dementia.

    5. Organizational factors of the nursing homes [At baseline]

      Organizational factors of the nursing homes and variables associated with the staff of the nursing homes will be collected at baseline, and the data will be used to explore associations between nursing home characteristics and the course of the symptoms in the patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    Memory clinic sample

    Inclusion Criteria:
    • All patients examined at a memory clinic with mild cognitive impairment or mild dementia
    Exclusion Criteria:
    • None

    In-home care sample

    Inclusion Criteria:
    • Persons 70 years of age or older receiving in-home care from the municipality
    Exclusion Criteria:
    • None

    Nursing-home sample

    Inclusion Criteria:
    • All persons admitted to the nursing home with an expected stay of more than four weeks.

    • Participants should be 65 years or older, unless established dementia disease, in which case younger persons also will be included

    Exclusion Criteria:
    • Life expectancy of less than six weeks

    Control sample

    Inclusion Criteria:
    • Persons 65 years or older without any sign of dementia
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Bergen Bergen Norway
    2 Senter for omsorgsforskning - Midt Namsos Norway
    3 Innlandet Hospital Trust Ottestad Norway 2512

    Sponsors and Collaborators

    • Sykehuset Innlandet HF
    • Norwegian Directorate of Health
    • King's College London
    • Karolinska Institutet
    • Oslo University Hospital
    • University Hospital, Akershus
    • Helse Midt-Norge
    • Norwegian University of Science and Technology
    • University of Bergen
    • Norwegian Centre for Ageing and Health

    Investigators

    • Principal Investigator: Geir Selbaek, pHd, Centre for old age psychiatry research, Innlandet Hospital Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sykehuset Innlandet HF
    ClinicalTrials.gov Identifier:
    NCT01920100
    Other Study ID Numbers:
    • E13237
    First Posted:
    Aug 9, 2013
    Last Update Posted:
    Aug 11, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Sykehuset Innlandet HF
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 11, 2021