NCT01920100

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 the course of dementia, the economical cost of dementia and to look into possible risk factors for dementia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
696

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
8.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

5.8 years

First QC Date

August 5, 2013

Last Update Submit

November 21, 2023

Conditions

Keywords

Health Care CostsGenetic Polymorphism

Outcome Measures

Primary Outcomes (1)

  • Cost of dementia

    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.

    3 years

Secondary Outcomes (5)

  • The course of neuropsychiatric symptoms

    3 years

  • Quality of Life in persons admitted to nursing homes

    3 years

  • Prescription of medication

    3 years

  • DNA polymorphism

    At baseline

  • Organizational factors of the nursing homes

    At baseline

Study Arms (4)

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 Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All patients examined at a memory clinic with mild cognitive impairment or mild dementia

You may not qualify if:

  • None
  • In-home care sample
  • Persons 70 years of age or older receiving in-home care from the municipality
  • None
  • Nursing-home sample
  • 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
  • Life expectancy of less than six weeks
  • Control sample
  • Persons 65 years or older without any sign of dementia
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Bergen

Bergen, Norway

Location

Senter for omsorgsforskning - Midt

Namsos, Norway

Location

Innlandet Hospital Trust

Ottestad, 2512, Norway

Location

Related Publications (3)

  • Sandvik RKNM, Husebo BS, Selbaek G, Strand G, Patrascu M, Mustafa M, Bergh S. Oral symptoms in dying nursing home patients. Results from the prospective REDIC study. BMC Oral Health. 2024 Jan 25;24(1):129. doi: 10.1186/s12903-024-03901-x.

  • Callegari E, Saltyte Benth J, Selbaek G, Gronnerod C, Bergh S. Do prescription rates of psychotropic drugs change over three years from nursing home admission? BMC Geriatr. 2021 Sep 16;21(1):496. doi: 10.1186/s12877-021-02437-x.

  • Sandvik RK, Selbaek G, Bergh S, Aarsland D, Husebo BS. Signs of Imminent Dying and Change in Symptom Intensity During Pharmacological Treatment in Dying Nursing Home Patients: A Prospective Trajectory Study. J Am Med Dir Assoc. 2016 Sep 1;17(9):821-7. doi: 10.1016/j.jamda.2016.05.006. Epub 2016 Jun 16.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Neurodegenerative DiseasesDementia

Condition Hierarchy (Ancestors)

Nervous System DiseasesBrain DiseasesCentral Nervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Geir Selbaek, pHd

    Centre for old age psychiatry research, Innlandet Hospital Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2013

First Posted

August 9, 2013

Study Start

April 1, 2009

Primary Completion

January 1, 2015

Study Completion

November 1, 2023

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

On request

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations