Clinical trial NCT04043364: Live@Home.Path: Innovating the Clinical Pathway for Home Dwelling Persons With Dementia and Their Families
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Home-dwelling
Caregiver
Keywords: Learning
Innovation
Volunteers
Empowerment
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Haraldsplass Deaconal Hospital
name: Western Norway University of Applied Sciences
name: Norwegian Reseach Centre AS (NORCE)
name: Norwegian National Advisory Unit on Ageing and Health
name: Natioal Association for Public Health
name: Municipality of Bergen
name: Municipally of Kristiansund
name: Municipally of Bærum
name: The Dignity Centre
name: Harvard McLean University
name: Yale University
name: University College, London
name: University of Leiden
name: Tohoku University
name: King's College London
name: The University of Hong Kong
First posted: 2019-08-02
Enrollment: 280
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Mixed method, stepped wedge randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Home-dwelling people with dementia (PWD) equal or above 65 years diagnosed according to national guidelines
2. Mini mental state examination score 15-24
3. Functional Assessment Staging Test (FAST score 4-7)
4. Living with a partner, or have regular contact with a caregiver minimum 1 hour/week

Exclusion Criteria:

1. Participate in other trials
2. Expected survival under 4 weeks

Primary outcomes:
measure: Resource Utilization in Dementia
timeFrame: up to 24 months follow up, assesment every 6 months
measure: Relative stress scale
timeFrame: up to 24 months follow up, assessment every 6 months
Secondary outcomes:
measure: Activities of daily living, instrumental
timeFrame: 24 months follow up, assesment every 6 months
measure: Depression and mood
timeFrame: 24 months follow up, assesment every 6 months
measure: Agitation
timeFrame: 24 months follow up, assesment every 6 months
measure: Neuropsychiatric symptoms
timeFrame: 24 months follow up, assesment every 6 months
measure: Adverse events
timeFrame: 24 months follow up, assesment every 6 months
measure: Use of assistive technology
timeFrame: 24 months follow up, assesment every 6 months
measure: Use of volunteers
timeFrame: 24 months follow up, assesment every 6 months
measure: Activities of daily living, personal
timeFrame: 24 months follow up, assesment every 6 months
measure: Quality of Life
timeFrame: 24 months follow up, assesment every 6 months
measure: Quality of Life VAS scale
timeFrame: 24 months follow up, assesment every 6 months
measure: Quality of Life
timeFrame: 24 months follow up, assesment every 6 months
measure: Use of volunteers
timeFrame: 24 months follow up, assesment every 6 months
measure: Change achieving
timeFrame: at the start of intervention, and every 6 months
measure: Caregiver depression
timeFrame: 24 months follow up, assesment every 6 months
measure: Comorbidity
timeFrame: 24 months follow up, assesment every 6 months
measure: Pain in dementia
timeFrame: 24 months follow up, assesment every 6 months
measure: Change in cognitive performance
timeFrame: Baseline
measure: Medication use
timeFrame: At the start of the intervention, and every 6 onth follow up
measure: Participation in educational programs
timeFrame: 24 months follow up, assessment every 6 months
Other outcomes:
measure: COVID-19: risk perception
timeFrame: month 6 to month 12 (during COVID-19 lock down in Norway)
measure: COVID-19: restrictions
timeFrame: month 6 to month 12 (during COVID-19 lock down in Norway)
measure: COVID-19: caregiver burden
timeFrame: month 6 to month 12 (during COVID-19 lock down in Norway)
measure: COVID-19: neuropsychiatric symptoms
timeFrame: month 6 to month 12 (during COVID-19 lock down in Norway)
measure: COVID-19: depression and mood
timeFrame: month 6 to month 12 (during COVID-19 lock down in Norway)
Locations:
city: Bergen
country: Norway
facility: University of Bergen
Study officials:
affiliation: University of Bergen
name: Bettina Husebø, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.