DementiaNCT02790372
The Effect of Case Conferencing in Nursing Homes
A study testing Case conferencing in people with Dementia and Neurobehavioral Manifestations, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This study evaluates the effect of using comprehensive geriatric assessment in combination with case conferences on the prevalence of neuropsychiatric symptoms (also known as behavioral and psychological symptoms of dementia) in Norwegian nursing homes Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Neurobehavioral Manifestations
- What is being tested?
- Case conferencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2015to 5 Apr 2017
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- registered as long term care patient
- been in the nursing home for more than a month
- Informed consent from the patient or legal guardians
Who cannot join
- life expectancy less than six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Comprehensive Geriatric Assessment and Case Conferencing on Neuropsychiatric Symptoms Among Patients in Norwegian Nursing Homes
This study evaluates the effect of using comprehensive geriatric assessment in combination with case conferences on the prevalence of neuropsychiatric symptoms (also known as behavioral and psychological symptoms of dementia) in Norwegian nursing homes
Read the detailed description
Long-term care patients in nursing homes (NH) are characterized by frailty and having multiple health problems and reduced quality of life. Some of these issues relates to the quality of care and do therefore possess a potential for improvement. There is a need for approaches enabling nurses to carry out effective interventions that can promote health related to sustain or improve the nursing home patients health status. Integrating a comprehensive geriatric assessment (CGA) and case conferencing (CC) might be an effective method to individualize care plans in order to improve quality of care.
The intervention nursing homes will implement CGA, using the International resident instrument suite for Long Term Care Facilities (InterRai LTCF) and CC. The patients will be included and assessed three times during a 12-month period (control and intervention NHs). In the intervention NHs the results from the CGA will be reviewed in monthly CCs. The CCs are structured and consist of four main steps; evaluating the effects of earlier interventions, defining patients risks or area for improvement, defining the aetiology of the risk or problem, defining interventions and measures for improvement along with an appropriate method for evaluation. The CC group's consensus is basis for the patient's care plan.
- Conditions
- Dementia, Neurobehavioral Manifestations
- Being tested
- Case conferencing
- Keywords
- Nursing homes, Norway
- Medical subject headings
- Dementia, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case conferencingOther
Intervention nursing homes carries out regularly case conferencing based on comprehensive geriatric assessments. Case conferencing is carried out each month for nursing home patients included in the study
| Study group | Role | What they receive |
|---|---|---|
| Control nursing homes | No intervention | Nursing homes carries out usual care |
| Intervention nursing homes | Active comparator | Nursing homes that carries out regularly case conferencing Receives: Other: Case conferencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of neuropsychiatric symptoms measured by neuropsychiatric inventory
Measured by neuropsychiatric inventory
Measured: 12 months
Secondary outcomes (3)
Depression measured by Cornell scale for depression in dementia
Measured by Cornell scale for depression in dementia
Measured: 12 months
Activities in daily living measured by Physical self-maintenance scale
Measured by Physical self-maintenance scale
Measured: 12 months
Quality of life measured by the Quality of Life in Late-Stage Dementia Scale
Measured by the Quality of Life in Late-Stage Dementia Scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startApr 2015
- Primary completion5 Apr 2017
- Study completion5 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sigrid Nakrem, phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790372
- Sponsor's protocol ID
- 2014/1642
- Status last verified
- Apr 2017
- First submitted
- 31 May 2016
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Nakrem S, Stensvik GT, Skjong RJ, Ostaszkiewicz J. Staff experiences with implementing a case conferencing care model in nursing homes: a focus group study. BMC Health Serv Res. 2019 Mar 27;19(1):191. doi: 10.1186/s12913-019-4034-0.
PubMed 30917815Stensvik GT, Helvik AS, Haugan G, Steinsbekk A, Salvesen O, Nakrem S. The short-term effect of a modified comprehensive geriatric assessment and regularly case conferencing on neuropsychiatric symptoms in nursing homes: a cluster randomized trial. BMC Geriatr. 2022 Apr 11;22(1):316. doi: 10.1186/s12877-022-02976-x.
PubMed 35410145
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Comprehensive Geriatric Assessment and Case Conferencing on Neuropsychiatric Symptoms Among Patients in Norwegian Nursing Homes
- ClinicalTrials.gov ID
- NCT02790372
- Acronym / sponsor ID
- 2014/1642
- Conditions
- Dementia, Neurobehavioral Manifestations
- Keywords
- Nursing homes, Norway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 5 Apr 2017 (actual)
- Study completion
- 5 Apr 2017 (actual)
- First posted
- 3 Jun 2016 (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 study evaluates the effect of using comprehensive geriatric assessment in combination with case conferences on the prevalence of neuropsychiatric symptoms (also known as behavioral and psychological symptoms of dementia) in Norwegian nursing homes
Detailed description
Long-term care patients in nursing homes (NH) are characterized by frailty and having multiple health problems and reduced quality of life. Some of these issues relates to the quality of care and do therefore possess a potential for improvement. There is a need for approaches enabling nurses to carry out effective interventions that can promote health related to sustain or improve the nursing home patients health status. Integrating a comprehensive geriatric assessment (CGA) and case conferencing (CC) might be an effective method to individualize care plans in order to improve quality of care.
The intervention nursing homes will implement CGA, using the International resident instrument suite for Long Term Care Facilities (InterRai LTCF) and CC. The patients will be included and assessed three times during a 12-month period (control and intervention NHs). In the intervention NHs the results from the CGA will be reviewed in monthly CCs. The CCs are structured and consist of four main steps; evaluating the effects of earlier interventions, defining patients risks or area for improvement, defining the aetiology of the risk or problem, defining interventions and measures for improvement along with an appropriate method for evaluation. The CC group's consensus is basis for the patient's care plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control nursing homes | No intervention | –Nursing homes carries out usual care |
| Intervention nursing homes | Active comparator | Other: Case conferencingNursing homes that carries out regularly case conferencing |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- registered as long term care patient
- been in the nursing home for more than a month
- Informed consent from the patient or legal guardians
Key exclusion criteria (1 listed)
- life expectancy less than six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case conferencingIntervention nursing homes carries out regularly case conferencing based on comprehensive geriatric assessments. Case conferencing is carried out each month for nursing home patients included in the study | Other | Intervention nursing homes |
Primary outcome
Prevalence of neuropsychiatric symptoms measured by neuropsychiatric inventory
Time frame: 12 months
Measured by neuropsychiatric inventory
3 secondary outcomes
Depression measured by Cornell scale for depression in dementia
Time frame: 12 months
Activities in daily living measured by Physical self-maintenance scale
Time frame: 12 months
Quality of life measured by the Quality of Life in Late-Stage Dementia Scale
Time frame: 12 months
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 4 Jun 2020.
- Results publication: PubMed 30917815Nakrem S, Stensvik GT, Skjong RJ, Ostaszkiewicz J. Staff experiences with implementing a case conferencing care model in nursing homes: a focus group study. BMC Health Serv Res. 2019 Mar 27;19(1):191. doi: 10.1186/s12913-019-4034-0.
- Derived from this study: PubMed 35410145Stensvik GT, Helvik AS, Haugan G, Steinsbekk A, Salvesen O, Nakrem S. The short-term effect of a modified comprehensive geriatric assessment and regularly case conferencing on neuropsychiatric symptoms in nursing homes: a cluster randomized trial. BMC Geriatr. 2022 Apr 11;22(1):316. doi: 10.1186/s12877-022-02976-x.
- Individual participant dataSharing planned: Yes
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
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.
Sigrid Nakrem, phd principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case conferencing in people with Dementia and Neurobehavioral Manifestations, run by Norwegian University of Science and Technology at 1 site 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 3 inclusion and 1 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Prevalence of neuropsychiatric symptoms measured by neuropsychiatric inventory (time frame: 12 months). 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 NCT02790372, which also lists 2 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 4 Jun 2020.