Live@Home.Path: Innovating the Clinical Pathway for Home Dwelling Persons With Dementia and Their Families (LIVE)

Live@Home.Path: Innovating the Clinical Pathway for Home Dwelling Persons With Dementia and Their Families

LIVE@Home.Path: a Mixed Method, Stepped Wedge and Randomized Controlled Trial Innovating the Clinical Pathway for Home-dwelling Persons With Dementia and Their Families

Haraldsplass Deaconal Hospital, Western Norway University of Applied Sciences, Norwegian Reseach Centre AS (NORCE), Norwegian National Advisory Unit on Ageing and Health, Natioal Association for Public Health, Municipality of Bergen, Municipally of Kristiansund, Municipally of Bærum, The Dignity Centre, Harvard McLean University, Yale School of Medicine, University College, London, University of Leiden, Tohoku University, King's College London, The University of Hong Kong

This study aims at developing, implementing and evaluating a complex intervention involving Learning, Innovation, Volunteers and Empowerment for home dwelling persons with dementia and their caregivers. The investigators hypothesise that a successfully implemented intervention will reduce caregivers burden and be cost-effective.

The provision of economically viable and proper care for the growing group of home-dwelling people with dementia (PWD) is one of the most pressing issues in our society. While a cure for dementia is not yet available, professionals and policy-makers highly prioritize the support of caregivers who experience a vast burden. However, there is a lack of high-quality research investigating clinical, social and economic factors that may add beneficial effects. This project aims to develop, test, and implement a complex intervention for PWD, intended to reduce caregivers' burden, which will aid PWD to stay safely, longer and independently at home with dignity and cost-effectiveness. The term informal caregivers' burden may include different meanings for different people and be related to economic burden, depression and anxiety, quality of life (QoL), or simply the quality of sleep and recreation. In a stepped wedge, cluster randomized controlled trial, involving primary and secondary health care systems in Bergen, Bærum and Kristiansand the 24-month LIVE@Home.Path study will be undertaken in a stepped wedge design. The user-inspired and tailored intervention includes a designated coordinator to the PWD and caregiver for 6 months to introduce a complex intervention involving a) Learning b) Innovation c) Volunteers and d) Empowerment. Qualitative interviews will determine users' values and wishes, and promotors and barriers for successful implementation of the intervention. Primary and secondary outcomes on cognitive, emotional and social factors, cost-benefit analyses, and QoL of PWD and families will be assessed every 6-month over 2 years. Update spring 2020: The COVID-19 pandemic severely hampered the implementation of the intervention for the second group. We therefore had to change the design, postponing the intervention in Bærum and Kristiansand, and delivering the intervention in Bergen by phone. In addition, we initiated the PAN.DEM in the LIVE@Home.Path trial, collecting data from phone interviews with caregivers on change in Health services and neuropsychiatric symptoms, risk perception and restrictions. Changes in design approved by Ethical committee (REK: 10861).

A multicomponent intervention focusing on Learning, Innovation, Volunteers and Empowerment organized by a local coordinator.

RUD:A validated tool for assessment of time use for cost effectiveness analyses, measuring total time use in hours/day for different activities, numbers of contact points with care professionals and use of medications, high time use, many contacts and many medications indicates high resource use

I-ADL scale assessing instrumental activities such as use of telephone, economy, household, public transport and shopping, range from 8-31, higher score indicates poorer functioning

CMAI: Cohen-Mansfield Agitation Inventory, 29 items assessing the frequency of agitated behaviour, range 29-203, high score indicates higher severity

NPI: presence, severity and burden of depression, anxiety, psychosis and motor disturbances, range from 0-144, high score indicates frequent, severe and burdensome symptoms

P-ADL, assessing personal activities such as toileting, grooming, dressing, transfer and eating, scale range 6-30, higher score indicates poorer personal functioning

EQ-5D-5L, Descriptive measure of health related quality of life comprising 5 Dimensions With 5 Levels each, scores can be converted to a single summary index number

EQ-5D, Descriptive measure of quality of life rated on a VAS scale range 0-100, high score indicates good health

QoL-AD: Quality of life in Alzheimer dementia, 13 items likert scale, range from 13-52 points, high score indicates high quality of life

Clinical global impression of change, to quantify and track patient progress and treatment response on a scale from 1 to 7, at which 7 indicates substantial worsening.

GMHR: General medical health rating scale, 4 point likert scale, range from 1-4, high score indicates high comorbidity burden

MOBID-2: assesses the intensity of pain based on interpretation of pain related behaviour, range from 0-10, high score indicates high pain intensity

IQ CODE: Proxy rater instrument for assessment of change in cognitive performance the last 10 years, range 16-80, high score indicates great decline

NPI: change in presence, severity and burden of depression, anxiety, psychosis and motor disturbances

Inclusion Criteria: Home-dwelling people with dementia (PWD) equal or above 65 years diagnosed according to national guidelines Mini mental state examination score 15-24 Functional Assessment Staging Test (FAST score 4-7) Living with a partner, or have regular contact with a caregiver minimum 1 hour/week Exclusion Criteria: Participate in other trials Expected survival under 4 weeks

We plan to make individual participant data available to collaborators and researchers affiliated with the project.

Husebo BS, Allore H, Achterberg W, Angeles RC, Ballard C, Bruvik FK, Faeo SE, Gedde MH, Hillestad E, Jacobsen FF, Kirkevold O, Kjerstad E, Kjome RLS, Mannseth J, Naik M, Nouchi R, Puaschitz N, Samdal R, Tranvag O, Tzoulis C, Vahia IV, Vislapuu M, Berge LI. 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. Trials. 2020 Jun 9;21(1):510. doi: 10.1186/s13063-020-04414-y.

Gedde MH, Husebo BS, Erdal A, Puaschitz NG, Vislapuu M, Angeles RC, Berge LI. Access to and interest in assistive technology for home-dwelling people with dementia during the COVID-19 pandemic (PAN.DEM). Int Rev Psychiatry. 2021 Jun;33(4):404-411. doi: 10.1080/09540261.2020.1845620. Epub 2021 Jan 8.

Angeles RC, Berge LI, Gedde MH, Kjerstad E, Vislapuu M, Puaschitz NG, Husebo BS. Which factors increase informal care hours and societal costs among caregivers of people with dementia? A systematic review of Resource Utilization in Dementia (RUD). Health Econ Rev. 2021 Sep 18;11(1):37. doi: 10.1186/s13561-021-00333-z.

Puaschitz NG, Jacobsen FF, Mannseth J, Angeles RC, Berge LI, Gedde MH, Husebo BS. Factors associated with access to assistive technology and telecare in home-dwelling people with dementia: baseline data from the LIVE@Home.Path trial. BMC Med Inform Decis Mak. 2021 Sep 15;21(1):264. doi: 10.1186/s12911-021-01627-2.

Vislapuu M, Angeles RC, Berge LI, Kjerstad E, Gedde MH, Husebo BS. The consequences of COVID-19 lockdown for formal and informal resource utilization among home-dwelling people with dementia: results from the prospective PAN.DEM study. BMC Health Serv Res. 2021 Sep 22;21(1):1003. doi: 10.1186/s12913-021-07041-8.

Husebo BS, Berge LI. Intensive Medicine and Nursing Home Care in Times of SARS CoV-2: A Norwegian Perspective. Am J Geriatr Psychiatry. 2020 Jul;28(7):792-793. doi: 10.1016/j.jagp.2020.04.016. Epub 2020 Apr 22. No abstract available.

Husebo BS, Heintz HL, Berge LI, Owoyemi P, Rahman AT, Vahia IV. Sensing Technology to Monitor Behavioral and Psychological Symptoms and to Assess Treatment Response in People With Dementia. A Systematic Review. Front Pharmacol. 2020 Feb 4;10:1699. doi: 10.3389/fphar.2019.01699. eCollection 2019. Erratum In: Front Pharmacol. 2020 Mar 06;11:254.

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.

Faeo SE, Bruvik FK, Tranvag O, Husebo BS. Home-dwelling persons with dementia's perception on care support: Qualitative study. Nurs Ethics. 2020 Jun;27(4):991-1002. doi: 10.1177/0969733019893098. Epub 2020 Jan 27.

Faeo SE, Tranvag O, Samdal R, Husebo BS, Bruvik FK. The compound role of a coordinator for home-dwelling persons with dementia and their informal caregivers: qualitative study. BMC Health Serv Res. 2020 Nov 16;20(1):1045. doi: 10.1186/s12913-020-05913-z.

Faeo SE, Husebo BS, Bruvik FK, Tranvag O. "We live as good a life as we can, in the situation we're in" - the significance of the home as perceived by persons with dementia. BMC Geriatr. 2019 Jun 6;19(1):158. doi: 10.1186/s12877-019-1171-6.

Gedde MH, Husebo BS, Mannseth J, Naik M, Selbaek G, Vislapuu M, Berge LI. The impact of medication reviews by general practitioners on psychotropic drug use and behavioral and psychological symptoms in home-dwelling people with dementia: results from the multicomponent cluster randomized controlled LIVE@Home.Path trial. BMC Med. 2022 May 26;20(1):186. doi: 10.1186/s12916-022-02382-5.

Berge LI, Gedde MH, Torrado Vidal JC, Husebo B, Hynninen KM, Knardal SE, Madso KG. The acceptability, adoption, and feasibility of a music application developed using participatory design for home-dwelling persons with dementia and their caregivers. The "Alight" app in the LIVE@Home.Path trial. Front Psychiatry. 2022 Aug 18;13:949393. doi: 10.3389/fpsyt.2022.949393. eCollection 2022.

Gedde MH, Husebo BS, Vahia IV, Mannseth J, Vislapuu M, Naik M, Berge LI. Impact of COVID-19 restrictions on behavioural and psychological symptoms in home-dwelling people with dementia: a prospective cohort study (PAN.DEM). BMJ Open. 2022 Jan 24;12(1):e050628. doi: 10.1136/bmjopen-2021-050628.

Access to and interest in assistive technology for home-dwelling people with dementia during the COVID-19 pandemic (PAN.DEM)

Which factors increase informal care hours and societal costs among caregivers of people with dementia? A systematic review of Resource Utilization in Dementia (RUD).

Factors associated with access to assistive technology and telecare in home-dwelling people with dementia: baseline data from the LIVE@Home.Path trial

The consequences of COVID-19 lockdown for formal and informal resource utilization among home-dwelling people with dementia: results from the prospective PAN.DEM study

Sensing Technology to Monitor Behavioral and Psychological Symptoms and to Assess Treatment Response in People With Dementia

The Impact of Deprescribing Psychotropic Drugs on Behavioral and Psychological Symptoms and Daily Functioning in Nursing Home Patients

Fæø SE, Bruvik FK, Tranvåg O, Husebo BS. Home-dwelling persons with dementia's perception on care support

The compound role of a coordinator for home-dwelling persons with dementia and their informal caregivers: qualitative study

We live as good a life as we can, in the situation we're in" - the significance of the home as perceived by persons with dementia.

The impact of medication reviews by general practitioners on psychotropic drug use and behavioral and psychological symptoms in home-dwelling people with dementia: results from the multicomponent cluster randomized controlled LIVE@Home.Path trial