LIVE@Home.Path-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, 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

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 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 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.

Keywords: Caregiver burden; Dementia care; Home-dwelling; Multicomponent interventions; Resource utilization; Service collaboration; Stepped-wedge randomization.

Conflict of interest statement

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.

Figures

Fig. 1
Fig. 1
Learning (L), Innovation (I), Volunteering (V) and Empowerment (E)
Fig. 2
Fig. 2
a Stepped-wedge randomized control design. The randomization in time takes place at month 0. First group (red) is in the intervention period from month 1 to 6, second group (yellow) from month 7 to 12 and third group (green) from month 13 to 18. Implementation seminars will be held at months 0, 6 and 12, and midway evaluation at months 3, 9 and 15. Data will be collected at baseline (month 0), after the first intervention period (month 6–7), after the second intervention period (month 12–13), after the third intervention period (month 18–19) and at the end of the study at 24 months. b Schedule of enrollment, interventions and assessments over the study period
Fig. 3
Fig. 3
Framework for sustainable ethic innovation in dementia research

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