[email protected]—innovating the clinical pathway for home-dwelling people with dementia and their caregivers: study protocol for a mixed-method, stepped-wedge, randomized controlled trial
Bettina Sandgathe Husebo,
Heather Allore,
Wilco Achterberg,
Renira Corinne Angeles,
Clive Ballard,
Frøydis Kristine Bruvik,
Stein Erik Fæø,
Marie Hidle Gedde,
Eirin Hillestad,
Frode Fadnes Jacobsen,
Øyvind Kirkevold,
Egil Kjerstad,
Reidun Lisbeth Skeide Kjome,
Janne Mannseth,
Mala Naik,
Rui Nouchi,
Nathalie Puaschitz,
Rune Samdal,
Oscar Tranvåg,
Charalampos Tzoulis,
Ipsit Vihang Vahia,
Maarja Vislapuu,
Line Iden Berge
Affiliations
Bettina Sandgathe Husebo
Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen
Heather Allore
Department of Internal Medicine, Section of Geriatrics, Yale School of Medicine
Wilco Achterberg
Department of Public Health and Primary Care, Leiden University Medical Center
Renira Corinne Angeles
NORCE Norwegian Research Centre
Clive Ballard
College of Medicine and Health, University of Exeter
Frøydis Kristine Bruvik
Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen
Stein Erik Fæø
Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen
Marie Hidle Gedde
Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen
Eirin Hillestad
Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen
Frode Fadnes Jacobsen
Vid Specialized University
Øyvind Kirkevold
Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust
Egil Kjerstad
NORCE Norwegian Research Centre
Reidun Lisbeth Skeide Kjome
Centre for Pharmacy, Department of Global Public Health and Primary Care, University of Bergen
Janne Mannseth
Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen
Mala Naik
Haraldsplass Deaconess Hospital
Rui Nouchi
Department of Cognitive Health Science, Institute of Development, Aging and Cancer, Tohoku University
Nathalie Puaschitz
Centre for Care Research, Western Norway University of Applied Sciences
Rune Samdal
Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen
Oscar Tranvåg
Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen
Charalampos Tzoulis
Neuro-SysMed, Department of Neurology, Haukeland University Hospital
Ipsit Vihang Vahia
McLean Hospital
Maarja Vislapuu
Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen
Line Iden Berge
Centre for Elderly and Nursing Home Medicine, Department of Global Public Health and Primary Care, Faculty of Medicine, University of Bergen
Abstract 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 [email protected] trial. Methods The [email protected] 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 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.
