Neurodegenerative DiseasesREDICNCT01920100
Resource Use and Disease Course in Dementia (REDIC)
An observational study of Neurodegenerative Diseases and Dementia, run by Sykehuset Innlandet HF at 3 sites in Norway.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases, Dementia
- How many people
- 696 participants
- Where
- 3 sitesNorway
- Study dates
- Apr 2009to Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Nursing home Memory clinics In-home care Persons without dementia (Control)
Who may be able to join
- All patients examined at a memory clinic with mild cognitive impairment or mild dementia
- Persons 70 years of age or older receiving in-home care from the municipality
- 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
- Persons 65 years or older without any sign of dementia
Who cannot join
- None
- In-home care sample
- None
- Nursing-home sample
- Life expectancy of less than six weeks
- Control sample
- None
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
University of Bergen
Bergen
Senter for omsorgsforskning - Midt
Namsos
Innlandet Hospital Trust
Ottestad, 2512
About this study
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.
- Conditions
- Neurodegenerative Diseases, Dementia
- Keywords
- Health Care Costs, Genetic Polymorphism
- Medical subject headings
- Neurodegenerative Diseases, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startApr 2009
- Primary completionJan 2015
- Study completionNov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 696 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Geir Selbaek, pHd, Principal investigator, Centre for old age psychiatry research, Innlandet Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920100
- Sponsor's protocol ID
- E13237
- Acronym
- REDIC
- Status last verified
- Nov 2023
- First submitted
- 5 Aug 2013
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: On request
Publications
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.
PubMed 38273300Callegari 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.
PubMed 34530728Sandvik 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.
PubMed 27321869
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resource Use and Disease Course in Dementia (REDIC)
- ClinicalTrials.gov ID
- NCT01920100
- Acronym / sponsor ID
- REDIC / E13237
- Conditions
- Neurodegenerative Diseases, Dementia
- Keywords
- Health Care Costs, Genetic Polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 696 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- 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
- Study start
- Apr 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- Nov 2023 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nursing home Memory clinics In-home care Persons without dementia (Control)
Key inclusion criteria (5 listed)
- All patients examined at a memory clinic with mild cognitive impairment or mild dementia
- Persons 70 years of age or older receiving in-home care from the municipality
- 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
- Persons 65 years or older without any sign of dementia
Key exclusion criteria (7 listed)
- None
- In-home care sample
- None
- Nursing-home sample
- Life expectancy of less than six weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cost of dementia
Time frame: 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.
5 secondary outcomes
The course of neuropsychiatric symptoms
Time frame: 3 years
Quality of Life in persons admitted to nursing homes
Time frame: 3 years
Prescription of medication
Time frame: 3 years
DNA polymorphism
Time frame: At baseline
Organizational factors of the nursing homes
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 38273300Sandvik 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.
- Derived from this study: PubMed 34530728Callegari 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.
- Derived from this study: PubMed 27321869Sandvik 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.
- Link to web page with a working paper describing the projectLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. On request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geir Selbaek, pHd principal investigator
Centre for old age psychiatry research, Innlandet Hospital Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodegenerative Diseases and Dementia, run by Sykehuset Innlandet HF at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost of dementia (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920100, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.