Resource Use and Disease Course in Dementia (REDIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Sykehuset Innlandet HF
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Sykehuset Innlandet HF
ClinicalTrials.gov Identifier:
NCT01920100
First received: August 5, 2013
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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
Neurodegenerative Diseases
Dementia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Resource Use and Disease Course in Dementia (REDIC)

Resource links provided by NLM:


Further study details as provided by Sykehuset Innlandet HF:

Primary Outcome Measures:
  • Cost of dementia [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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:
  • The course of neuropsychiatric symptoms [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.

  • Quality of Life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.

  • Prescription of medication [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.

  • DNA polymorphism [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    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.

  • Organizational factors of the nursing homes [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

DNA samples are collected by mouth swabs from persons recruited from nursing homes.


Estimated Enrollment: 2800
Study Start Date: April 2009
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Nursing home Memory clinics In-home care Persons without dementia (Control)

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920100

Contacts
Contact: Geir Selbaek, PhD +4795883535 geir.selbaek@aldringoghelse.no
Contact: Sverre Bergh, PhD +4745679393 sverre.bergh@sykehuset-innlandet.no

Locations
Norway
University of Bergen Recruiting
Bergen, Norway
Contact: Reidun , Sandvik    +4741649966    Reidun.Karin.Sandvik@hib.no   
Principal Investigator: Reidun Sandvik, MD         
Senter for omsorgsforskning - Midt Recruiting
Namsos, Norway
Contact: Karin Torvik, PhD    +4792404881    karin.torvik@hint.no   
Principal Investigator: Karin Torvik, PhD         
Innlandet Hospital Trust Recruiting
Ottestad, Norway, 2512
Contact: Geir Selbaek, PhD    +4795883535    geir.selbaek@aldringoghelse.no   
Principal Investigator: Geir Selbaek, PhD         
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
  More Information

Additional Information:
No publications provided

Responsible Party: Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT01920100     History of Changes
Other Study ID Numbers: E13237
Study First Received: August 5, 2013
Last Updated: August 9, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Sykehuset Innlandet HF:
Health Care Costs
Genetic Polymorphism

Additional relevant MeSH terms:
Dementia
Neurodegenerative Diseases
Disease Progression
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014