Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy
NCT ID: NCT02238652
Last Updated: 2016-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
560 participants
INTERVENTIONAL
2014-08-31
2015-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A cluster randomized clinical trial of efficacy - The KOSMOS study.
COSMOS (COmmunication (Advance Care Planning - ACP), Systematic pain assessment and treatment, Medication review, Occupational therapy, and Safety) is a practical intervention aimed to improve clinical and psychiatric challenges in NH patients. The COSMOS intervention combines the most effective research results to improve staff competence and patients' mental health, safety, QoL. We also aim to reduce psychotropic drug use and costs.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CONSTELLATIONS Living Lab: Improving the Care Transitions of Older Adults Living with Neurocognitive Disorders
NCT06608589
Enhancing Quality of Life for Nursing Home Residents
NCT00388544
The Hospice Advanced Dementia Symptom Management and Quality of Life Trial
NCT03681119
Relative Patient Benefits of a Hospital-PCMH Collaboration Within an ACO to Improve Care Transitions
NCT02130570
Multicomponent Intervention in Caregivers on Quality of Life of People With Dementia: a Clinical Trial
NCT04280861
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Research questions and hypotheses:
1. Will the implementation of a communication and end-of-life decision making process have impact on interactions between patients, staff and family? We hypothesize that ACP will improve the interactions between patients, staff and family, and satisfaction in relatives and thereby improve the quality of life NH patients.
2. Is the KOSMOS capable to affect agitation and aggression and reduce medication e.g. psychotropics in NH patient? We hypothesize that KOSMOS will significantly reduce agitation and aggression, the total amount of medication, and psychotropic drug use.
3. What combination of interventions will give the broadest benefit, and could be delivered as a routine intervention as part of NH practice? We hypothesize that the comprehensive KOSMOS approach improves QoL and makes positive changes in NH practice.
4. What other types of advantages are expected? We hypothesize that KOSMOS is a cost-effective approach, with potential to increase the safety and reduce mortality in NH patients.
Method: The KOSMOS intervention combines the most effective research results to improve staff competence, and patients' mental health, safety, QoL, and to reduce psychotropic drug use and costs. The efficacy testing of KOSMOS includes systematic literature review, a pilot study, a 9-month randomized control trial (RCT), and a dissemination plan. Data collection will take place at baseline, months 4, and 9. The intervention entails provision of staff training, study guidelines and manuals. NHs will be randomized to either KOSMOS or current best practice. We will include 38 NH long-term-care (LTC) wards (normally just one ward per NH) in Bergen, Stavanger, Oslo/Bærum, Sarpsborg and Sogn and Fjordane. In total 310 patients ≥65 years will be recruited from these wards
Primary and secondary outcome measures: Quality of life in late stage dementia (QUALID), QUALIDEM, EQ-5-D; Neuropsychiatric Inventory - NH edition (NPI-NH); Activities of Daily Living (ADL); Cornell; Mobilization - Observation - Behaviour - Intensity - Dementia 2 (MOBID-2); drug use; drug-related problems, START; STOP; cost-utility analysis (RUD-FOCA); hospital admission; and mortality, ActiWatch; Log registration of NH activities; Relatives satisfaction with conducted KOSMOS elements
Statistical analyses: include characteristics between 2 groups (Chi square, Mann-Whitney U), ANCOVA, ICC and p-values for each time-point and outcomes.
National and international collaboration: National collaboration between researchers at the Universities of Bergen, Oslo, and Stavanger is established. Internationally, colleagues from the EU COST-Action TD1005, Karolinska University, Stockholm and Kings College, London are engaged in this RCT.
Funding: The employment of two PhD-candidates (100%) and one post-doctoral fellow (50%) received funding by the Norwegian Research Council (Sponsor's Protocol Code: 222113) in 2012.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
No interventions assigned to this group
Intervention
Communication Systematic Pain Assessment and Treatment Medication Review Occupational therapy Safety
Communication
A preparation process before the patient become incapable of participating in life prolonging decisions
Systematic Pain Assessment and Treatment
Assess pain with MOBID-2 Pain Scale and thereby improve pain management in dementia.
Medication Review
An individual and systematic review of medication prescriptions to identify possible harmful drug effects and to reduce the use of psychotropic drugs.
Occupational therapy
Increase individual activities, based on function, personal interest and personality by educating the staff on these elements.
Safety
Focusing on developing a culture where staff has an active and constant awareness of how to prevent adverse events and a commitment to safety.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Communication
A preparation process before the patient become incapable of participating in life prolonging decisions
Systematic Pain Assessment and Treatment
Assess pain with MOBID-2 Pain Scale and thereby improve pain management in dementia.
Medication Review
An individual and systematic review of medication prescriptions to identify possible harmful drug effects and to reduce the use of psychotropic drugs.
Occupational therapy
Increase individual activities, based on function, personal interest and personality by educating the staff on these elements.
Safety
Focusing on developing a culture where staff has an active and constant awareness of how to prevent adverse events and a commitment to safety.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Active Schizophrenia
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Research Council of Norway
OTHER
Rebekka Ege Hegemanns legat
UNKNOWN
Helse Stavanger HF
OTHER_GOV
University of Oslo
OTHER
King's College London
OTHER
Karolinska Institutet
OTHER
University of Bergen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bettina Husebo
MD, assoc prof.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bettina S. Husebø, MD, PhD
Role: STUDY_DIRECTOR
University of Bergen
Elisabeth Flo, PysD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Bergen
Irene Aasmul, Master
Role: PRINCIPAL_INVESTIGATOR
University of Bergen
Christine Gulla, MD
Role: PRINCIPAL_INVESTIGATOR
University of Bergen
Torstein Habiger
Role: PRINCIPAL_INVESTIGATOR
University of Bergen
Tony Elvegaard
Role: PRINCIPAL_INVESTIGATOR
University of Bergen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Solvik
Baerum, Akershus, Norway
Donski Bo og behandlingssenter
Baerum, Akershus, Norway
Mariehaven Bo og behandlingssenter
Baerum, Akershus, Norway
Berger Bo og Behandlingssenter
Baerum, Akershus, Norway
Kolaashjemmet Bo og Behandlingssenter
Baerum, Akershus, Norway
Gullhaug Bo og behandlingssenter
Baerum, Akershus, Norway
Osteraas Bo og behandlingssenter
Baerum, Akershus, Norway
Solbakken Bo og Behandlingssenter
Baerum, Akershus, Norway
Lønnås Bo og Rehabsenter
Baerum, Akershus, Norway
Nordraaksvei bo og behandlingssenter
Baerum, Akershus, Norway
Stabaekktunet Bo og behandlingssenter
Baerum, Akershus, Norway
Stabekk Bo og Behandlingssenter
Baerum, Akershus, Norway
Ask bo og omsorgssenter
Askøy, , Norway
Arna helseheim
Bergen, , Norway
Frieda Fasmers minne
Bergen, , Norway
Gullstøltunet Sykehjem
Bergen, , Norway
Hospitalet Betanien
Bergen, , Norway
Lyngbøtunet Bo og servicesenter
Bergen, , Norway
Slettebakken menighets eldresenter
Bergen, , Norway
University of Bergen
Bergen, , Norway
Strandebarmheimen
Kvam, , Norway
Toloheimen
Kvam, , Norway
Øysteseheimen
Kvam, , Norway
Borgen sykehjem
Sarpsborg, , Norway
Eplehagen bofellesskap
Sarpsborg, , Norway
Haugvoll sykehjem
Sarpsborg, , Norway
Helsehuset
Sarpsborg, , Norway
Kurland
Sarpsborg, , Norway
Tingvoll sykehjem
Sarpsborg, , Norway
Valaskjold omsorgssenter
Sarpsborg, , Norway
Sundheimen
Sund, , Norway
Tednebakkane omsorgssenter
Øygarden, , Norway
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Husebo BS, Flo E, Aarsland D, Selbaek G, Testad I, Gulla C, Aasmul I, Ballard C. COSMOS--improving the quality of life in nursing home patients: protocol for an effectiveness-implementation cluster randomized clinical hybrid trial. Implement Sci. 2015 Sep 15;10:131. doi: 10.1186/s13012-015-0310-5.
Vislapuu M, Berge LI, Angeles RC, Kjerstad E, Mannseth J, Achterberg WP, Husebo BS. Factors associated with formal and informal resource utilization in nursing home patients with and without dementia: cross-sectional analyses from the COSMOS trial. BMC Health Serv Res. 2022 Nov 2;22(1):1306. doi: 10.1186/s12913-022-08675-y.
Flo-Groeneboom E, Elvegaard T, Gulla C, Husebo BS. The longitudinal association between the use of antihypertensive medications and 24-hour sleep in nursing homes: results from the randomized controlled COSMOS trial. BMC Geriatr. 2021 Jul 18;21(1):430. doi: 10.1186/s12877-021-02317-4.
Gedde MH, Husebo BS, Mannseth J, Kjome RLS, Naik M, Berge LI. Less Is More: The Impact of Deprescribing Psychotropic Drugs on Behavioral and Psychological Symptoms and Daily Functioning in Nursing Home Patients. Results From the Cluster-Randomized Controlled COSMOS Trial. Am J Geriatr Psychiatry. 2021 Mar;29(3):304-315. doi: 10.1016/j.jagp.2020.07.004. Epub 2020 Jul 11.
de Jong-Schmit BEM, Poortvliet RKE, Bohringer S, Bogaerts JMK, Achterberg WP, Husebo BS. Blood pressure, antihypertensive medication and neuropsychiatric symptoms in older people with dementia: The COSMOS study. Int J Geriatr Psychiatry. 2021 Jan;36(1):46-53. doi: 10.1002/gps.5388. Epub 2020 Oct 8.
Gulla C, Flo E, Kjome RLS, Husebo BS. Implementing a novel strategy for interprofessional medication review using collegial mentoring and systematic clinical evaluation in nursing homes (COSMOS). BMC Geriatr. 2019 May 7;19(1):130. doi: 10.1186/s12877-019-1139-6.
Habiger TF, Achterberg WP, Flo E, Husebo BS. Psychosis symptoms in nursing home residents with and without dementia-Cross-sectional analyses from the COSMOS study. Int J Geriatr Psychiatry. 2019 May;34(5):683-691. doi: 10.1002/gps.5067. Epub 2019 Mar 4.
Aasmul I, Husebo BS, Sampson EL, Flo E. Advance Care Planning in Nursing Homes - Improving the Communication Among Patient, Family, and Staff: Results From a Cluster Randomized Controlled Trial (COSMOS). Front Psychol. 2018 Dec 4;9:2284. doi: 10.3389/fpsyg.2018.02284. eCollection 2018.
Aasmul I, Husebo BS, Flo E. Description of an advance care planning intervention in nursing homes: outcomes of the process evaluation. BMC Geriatr. 2018 Jan 25;18(1):26. doi: 10.1186/s12877-018-0713-7.
Blytt KM, Bjorvatn B, Husebo B, Flo E. Clinically significant discrepancies between sleep problems assessed by standard clinical tools and actigraphy. BMC Geriatr. 2017 Oct 27;17(1):253. doi: 10.1186/s12877-017-0653-7.
Related Links
Access external resources that provide additional context or updates about the study.
Centre for Elderly and Nursing Home Medicine
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
222113
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.