TY - JOUR
T1 - LIVE@Home.Path-innovating the clinical pathway for home-dwelling people with dementia and their caregivers
T2 - Study protocol for a mixed-method, stepped-wedge, randomized controlled trial
AU - Husebo, Bettina Sandgathe
AU - Allore, Heather
AU - Achterberg, Wilco
AU - Angeles, Renira Corinne
AU - Ballard, Clive
AU - Bruvik, Frøydis Kristine
AU - Fæø, Stein Erik
AU - Gedde, Marie Hidle
AU - Hillestad, Eirin
AU - Jacobsen, Frode Fadnes
AU - Kirkevold, Øyvind
AU - Kjerstad, Egil
AU - Skeide Kjome, Reidun Lisbeth
AU - Mannseth, Janne
AU - Naik, Mala
AU - Nouchi, Rui
AU - Puaschitz, Nathalie
AU - Samdal, Rune
AU - Tranvåg, Oscar
AU - Tzoulis, Charalampos
AU - Vahia, Ipsit Vihang
AU - Vislapuu, Maarja
AU - Berge, Line Iden
N1 - Funding Information:
HA’s work was supported by the National Institute of Aging (NIA) of the National Institutes of Health under Award Number U54AG063546, which funds NIA Imbedded Pragmatic Alzheimer’s Disease and AD-Related Dementias Clinical Trials Collaboratory (NIA IMPACT Collaboratory). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. HA is also funded by the NIA P30AG021342-16S1 and P50AG047270. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Funding Information:
The trial is funded by the Research Council of Norway (www.forskningsradet. no) (Sponsor's Protocol Code 273581), the Research Council of Norway (Sponsor's Protocol Code-pre-project 261626 (UiB) and 261605 (Haraldsplass Deaconess Hospital)), including two PhD positions (MV and MHG) and three postdoctoral positions (RCA, NP and LIB). The Dignity Centre funds one additional PhD position (EH). The sponsors will have no role in planning the design, collection, management, analysis, interpretation of data and writing of reports and will have no decision on where to submit the report for publication.
Funding Information:
The LIVE@Home.Path trial is funded by the Research Council of Norway with two PhD grants and three postdoctorate grants. The Centre for Elderly and Nursing Home medicine at the University of Bergen responsible for conducting the trial is funded by GC Rieber Foundations and the Norwegian Government. The authors acknowledge valuable support from the collaborating municipalities and their main contact person Anne Marie Hanson (Bærum), Beate Sørensen (Kristiansand) and Anita Krokeide (Bergen), as well as from The Dignity Centre, the Dam Foundation Western Norway University of Applied Sciences and the Norwegian National Advisory Unit on Women’s Health, Oslo University Hospital.
Publisher Copyright:
© The Author(s). 2020 Open Access
PY - 2020
Y1 - 2020
N2 - Background: The global health challenge of dementia is exceptional in size, cost and impact. It is the only top ten cause of death that cannot be prevented, cured or substantially slowed, leaving disease management, caregiver support and service innovation as the main targets for reduction of disease burden. Institutionalization of persons with dementia is common in western countries, despite patients preferring to live longer at home, supported by caregivers. Such complex health challenges warrant multicomponent interventions thoroughly implemented in daily clinical practice. This article describes the rationale, development, feasibility testing and implementation process of the LIVE@Home.Path trial. Methods: The LIVE@Home.Path trial is a 2-year, multicenter, mixed-method, stepped-wedge randomized controlled trial, aiming to include 315 dyads of home-dwelling people with dementia and their caregivers, recruited from 3 municipalities in Norway. The stepped-wedge randomization implies that all dyads receive the intervention, but the timing is determined by randomization. The control group constitutes the dyads waiting for the intervention. The multicomponent intervention was developed in collaboration with user-representatives, researchers and stakeholders to meet the requirements from the national Dementia Plan 2020. During the 6-month intervention period, the participants will be allocated to a municipal coordinator, the core feature of the intervention, responsible for regular contact with the dyads to facilitate L: Learning, I: Innovation, V: Volunteering and E: Empowerment (LIVE). The primary (Continued on next page) outcome is resource utilization. This is measured by the Resource Utilization in Dementia (RUD) instrument and the Relative Stress Scale (RSS), reflecting that resource utilization is more than the actual time required for caring but also how burdensome the task is experienced by the caregiver. Discussion: We expect the implementation of LIVE to lead to a pathway for dementia treatment and care which is cost-effective, compared to treatment as usual, and will support high-quality independent living, at home. Trial registration: ClinicalTrials.gov: NCT04043364. Registered on 15 March 2019.
AB - Background: The global health challenge of dementia is exceptional in size, cost and impact. It is the only top ten cause of death that cannot be prevented, cured or substantially slowed, leaving disease management, caregiver support and service innovation as the main targets for reduction of disease burden. Institutionalization of persons with dementia is common in western countries, despite patients preferring to live longer at home, supported by caregivers. Such complex health challenges warrant multicomponent interventions thoroughly implemented in daily clinical practice. This article describes the rationale, development, feasibility testing and implementation process of the LIVE@Home.Path trial. Methods: The LIVE@Home.Path trial is a 2-year, multicenter, mixed-method, stepped-wedge randomized controlled trial, aiming to include 315 dyads of home-dwelling people with dementia and their caregivers, recruited from 3 municipalities in Norway. The stepped-wedge randomization implies that all dyads receive the intervention, but the timing is determined by randomization. The control group constitutes the dyads waiting for the intervention. The multicomponent intervention was developed in collaboration with user-representatives, researchers and stakeholders to meet the requirements from the national Dementia Plan 2020. During the 6-month intervention period, the participants will be allocated to a municipal coordinator, the core feature of the intervention, responsible for regular contact with the dyads to facilitate L: Learning, I: Innovation, V: Volunteering and E: Empowerment (LIVE). The primary (Continued on next page) outcome is resource utilization. This is measured by the Resource Utilization in Dementia (RUD) instrument and the Relative Stress Scale (RSS), reflecting that resource utilization is more than the actual time required for caring but also how burdensome the task is experienced by the caregiver. Discussion: We expect the implementation of LIVE to lead to a pathway for dementia treatment and care which is cost-effective, compared to treatment as usual, and will support high-quality independent living, at home. Trial registration: ClinicalTrials.gov: NCT04043364. Registered on 15 March 2019.
KW - Caregiver burden
KW - Dementia care
KW - Home-dwelling
KW - Multicomponent interventions
KW - Resource utilization
KW - Service collaboration
KW - Stepped-wedge randomization
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U2 - 10.1186/s13063-020-04414-y
DO - 10.1186/s13063-020-04414-y
M3 - Article
C2 - 32517727
AN - SCOPUS:85086356576
SN - 1745-6215
VL - 21
JO - Trials
JF - Trials
IS - 1
M1 - 510
ER -