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

Dementia Clinical Trial

— LIVE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04043364
• Other study ID #: NFR 273581
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 280
• Est. completion date: December 31, 2023
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver
• Dementia
• Home-dwelling

Intervention

Behavioral:
• LIVE
Learning, Innovation, Volunteers and Empowerment

Locations

Country	Name	City	State
Norway	University of Bergen	Bergen

Sponsors (17)

Lead Sponsor

Collaborator

University of Bergen

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

Country where clinical trial is conducted

Norway, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: Front Pharmacol. 2020 Mar 06;11:254. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	COVID-19: risk perception	Caregivers perception of risk of contamination With Sars-Cov-10	month 6 to month 12 (during COVID-19 lock down in Norway)
Other	COVID-19: restrictions	Change in services and contact due to restrictions of COVID-19	month 6 to month 12 (during COVID-19 lock down in Norway)
Other	COVID-19: caregiver burden	Caregivers perception of caregiver burden during COVID-19	month 6 to month 12 (during COVID-19 lock down in Norway)
Other	COVID-19: neuropsychiatric symptoms	NPI: change in presence, severity and burden of depression, anxiety, psychosis and motor disturbances	month 6 to month 12 (during COVID-19 lock down in Norway)
Other	COVID-19: depression and mood	CSDD: Change in cornell scale for depression in dementia.	month 6 to month 12 (during COVID-19 lock down in Norway)
Primary	Resource Utilization in Dementia	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	up to 24 months follow up, assesment every 6 months
Primary	Relative stress scale	RSS: measuring caregiver distress, 15 items ranging from 0-4, high score indicates high burden	up to 24 months follow up, assessment every 6 months
Secondary	Activities of daily living, instrumental	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	24 months follow up, assesment every 6 months
Secondary	Depression and mood	CSDD: Cornell scale for depression in dementia, range 0-38, high score indicates high symptom load	24 months follow up, assesment every 6 months
Secondary	Agitation	CMAI: Cohen-Mansfield Agitation Inventory, 29 items assessing the frequency of agitated behaviour, range 29-203, high score indicates higher severity	24 months follow up, assesment every 6 months
Secondary	Neuropsychiatric symptoms	NPI: presence, severity and burden of depression, anxiety, psychosis and motor disturbances, range from 0-144, high score indicates frequent, severe and burdensome symptoms	24 months follow up, assesment every 6 months
Secondary	Adverse events	Falls, disappearances outdoor, admissions to acute wards, fire hazard	24 months follow up, assesment every 6 months
Secondary	Use of assistive technology	number of technical aids, cognitive intervention devices and assisted-living systems	24 months follow up, assesment every 6 months
Secondary	Use of volunteers	number of participants with contact with a volunteer, number of hours spent with volunteer	24 months follow up, assesment every 6 months
Secondary	Activities of daily living, personal	P-ADL, assessing personal activities such as toileting, grooming, dressing, transfer and eating, scale range 6-30, higher score indicates poorer personal functioning	24 months follow up, assesment every 6 months
Secondary	Quality of Life	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	24 months follow up, assesment every 6 months
Secondary	Quality of Life VAS scale	EQ-5D, Descriptive measure of quality of life rated on a VAS scale range 0-100, high score indicates good health	24 months follow up, assesment every 6 months
Secondary	Quality of Life	QoL-AD: Quality of life in Alzheimer dementia, 13 items likert scale, range from 13-52 points, high score indicates high quality of life	24 months follow up, assesment every 6 months
Secondary	Use of volunteers	number of hours spent with a volunteer	24 months follow up, assesment every 6 months
Secondary	Change achieving	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.	at the start of intervention, and every 6 months
Secondary	Caregiver depression	GDS: Geriatric depression scale, 30 items rated yeas or no, high score indicates high burden	24 months follow up, assesment every 6 months
Secondary	Comorbidity	GMHR: General medical health rating scale, 4 point likert scale, range from 1-4, high score indicates high comorbidity burden	24 months follow up, assesment every 6 months
Secondary	Pain in dementia	MOBID-2: assesses the intensity of pain based on interpretation of pain related behaviour, range from 0-10, high score indicates high pain intensity	24 months follow up, assesment every 6 months
Secondary	Change in cognitive performance	IQ CODE: Proxy rater instrument for assessment of change in cognitive performance the last 10 years, range 16-80, high score indicates great decline	Baseline
Secondary	Medication use	Self and proxy reported use of medications, both regular and on demand	At the start of the intervention, and every 6 onth follow up
Secondary	Participation in educational programs	Participation in educational programes, both for persons with dementia and for caregivers.	24 months follow up, assessment every 6 months

External Links

•   Access to and interest in assistive technology for home-dwelling people with dementia during the COVID-19 pandemic (PAN.DEM)
•   Factors associated with access to assistive technology and telecare in home-dwelling people with dementia: baseline data from the LIVE@Home.Path trial
•   Fæø SE, Bruvik FK, Tranvåg O, Husebo BS. Home-dwelling persons with dementia's perception on care support
•   Intensive Medicine and Nursing Home Care in Times of SARS CoV-2: A Norwegian Perspective
•   Protocol
•   Sensing Technology to Monitor Behavioral and Psychological Symptoms and to Assess Treatment Response in People With Dementia
•   The compound role of a coordinator for home-dwelling persons with dementia and their informal caregivers: qualitative study
•   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
•   The Impact of Deprescribing Psychotropic Drugs on Behavioral and Psychological Symptoms and Daily Functioning in Nursing Home Patients
•   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
•   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.
•   Which factors increase informal care hours and societal costs among caregivers of people with dementia? A systematic review of Resource Utilization in Dementia (RUD).