Improving Quality of Life in Nursing Home Residents: A Cluster Randomized Clinical Trial of Efficacy
KOSMOS
1 other identifier
interventional
560
1 country
32
Brief Summary
Improving quality of life (QoL) in residents of nursing homes: 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable quality-of-life
Started Aug 2014
32 active sites
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
First Submitted
Initial submission to the registry
July 7, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedApril 15, 2016
September 1, 2014
1.3 years
July 7, 2014
April 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Neuropsychiatric symptoms
Depression, anxiety an apathy will be assessed by the Neuropsychiatric Inventory - Nursing Home version (NPI-NH).
9 months
Quality of life
Assessing quality of life by Qualidem, QUALID and EQ-5D.
9 months
Secondary Outcomes (11)
Activities of daily living
9 months
Mood or depression
9 months
Pain
9 months
Medication review
9 months
Drug-related problems
9 months
- +6 more secondary outcomes
Other Outcomes (1)
Implementation indicators
9 months
Study Arms (2)
Control
NO INTERVENTIONIntervention
ACTIVE COMPARATORCommunication Systematic Pain Assessment and Treatment Medication Review Occupational therapy Safety
Interventions
A preparation process before the patient become incapable of participating in life prolonging decisions
Assess pain with MOBID-2 Pain Scale and thereby improve pain management in dementia.
An individual and systematic review of medication prescriptions to identify possible harmful drug effects and to reduce the use of psychotropic drugs.
Increase individual activities, based on function, personal interest and personality by educating the staff on these elements.
Focusing on developing a culture where staff has an active and constant awareness of how to prevent adverse events and a commitment to safety.
Eligibility Criteria
You may qualify if:
- Resident in long time care ward in Bergen, Bærum, Sarpsborg, Kvam, Fjell, Sund, Askøy and Øygarden
You may not qualify if:
- Dying patients with reduced consciousness at baseline
- Active Schizophrenia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Bergenlead
- The Research Council of Norwaycollaborator
- Rebekka Ege Hegemanns legatcollaborator
- Helse Stavanger HFcollaborator
- University of Oslocollaborator
- King's College Londoncollaborator
- Karolinska Institutetcollaborator
Study Sites (32)
Solvik
Baerum, Akershus, 1304, Norway
Donski Bo og behandlingssenter
Baerum, Akershus, 1346, Norway
Mariehaven Bo og behandlingssenter
Baerum, Akershus, 1346, Norway
Berger Bo og Behandlingssenter
Baerum, Akershus, 1349, Norway
Kolaashjemmet Bo og Behandlingssenter
Baerum, Akershus, 1352, Norway
Gullhaug Bo og behandlingssenter
Baerum, Akershus, 1354, Norway
Osteraas Bo og behandlingssenter
Baerum, Akershus, 1361, Norway
Solbakken Bo og Behandlingssenter
Baerum, Akershus, 1361, Norway
Lønnås Bo og Rehabsenter
Baerum, Akershus, 1362, Norway
Nordraaksvei bo og behandlingssenter
Baerum, Akershus, 1369, Norway
Stabaekktunet Bo og behandlingssenter
Baerum, Akershus, 1369, Norway
Stabekk Bo og Behandlingssenter
Baerum, Akershus, 1369, 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
Related Publications (10)
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.
PMID: 26374231BACKGROUNDVislapuu 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.
PMID: 36324159DERIVEDFlo-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.
PMID: 34275457DERIVEDGedde 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.
PMID: 32753339DERIVEDde 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.
PMID: 32748494DERIVEDGulla 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.
PMID: 31064365DERIVEDHabiger 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.
PMID: 30706561DERIVEDAasmul 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.
PMID: 30564163DERIVEDAasmul 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.
PMID: 29370766DERIVEDBlytt 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.
PMID: 29078755DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bettina S. Husebø, MD, PhD
University of Bergen
- PRINCIPAL INVESTIGATOR
Elisabeth Flo, PysD, PhD
University of Bergen
- PRINCIPAL INVESTIGATOR
Irene Aasmul, Master
University of Bergen
- PRINCIPAL INVESTIGATOR
Christine Gulla, MD
University of Bergen
- PRINCIPAL INVESTIGATOR
Torstein Habiger
University of Bergen
- PRINCIPAL INVESTIGATOR
Tony Elvegaard
University of Bergen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, assoc prof.
Study Record Dates
First Submitted
July 7, 2014
First Posted
September 12, 2014
Study Start
August 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
April 15, 2016
Record last verified: 2014-09