Resource Use and Disease Course in Dementia (REDIC) (REDIC)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neurodegenerative Diseases; Dementia

• Study Type: Observational
• Enrollment (Anticipated): 2800

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway
    • University of Bergen
  • Namsos, Norway
    • Senter for omsorgsforskning - Midt
  • Ottestad, Norway, 2512
    • Innlandet Hospital Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The course of neuropsychiatric symptoms	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.	3 years
Quality of Life in persons admitted to nursing homes	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 years
Prescription of medication	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.	3 years
DNA polymorphism	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.	At baseline
Organizational factors of the nursing homes	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.	At baseline

Collaborators and Investigators

• Sponsor: Sykehuset Innlandet HF
• Collaborators: King's College London; Karolinska Institutet; Oslo University Hospital; University of Bergen; Norwegian University of Science and Technology; Norwegian Centre for Ageing and Health; University Hospital, Akershus; Helse Midt-Norge; Norwegian Directorate of Health
• Investigators: Principal Investigator: Geir Selbaek, pHd, Centre for old age psychiatry research, Innlandet Hospital Trust

Publications and helpful links

General Publications

• 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. Erratum In: BMC Geriatr. 2022 Dec 22;22(1):993.
• 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.

Helpful Links

• Link to web page with a working paper describing the project

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): January 1, 2015
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: August 5, 2013
• First Submitted That Met QC Criteria: August 8, 2013
• First Posted (Estimate): August 9, 2013

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Genetic Polymorphism; Health Care Costs
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Disease Attributes; Disease Progression; Dementia; Neurodegenerative Diseases
• Other Study ID Numbers: E13237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF