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

March 6, 2023 updated by: University of Bergen

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5009
        • University of Bergen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIVE
A multicomponent intervention focusing on Learning, Innovation, Volunteers and Empowerment organized by a local coordinator.
Behavioral: LIVE
Learning, Innovation, Volunteers and Empowerment
No Intervention: Treatment as usual
Care coordination and facilitation as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resource Utilization in Dementia
Time Frame: up to 24 months follow up, assesment every 6 months
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
Relative stress scale
Time Frame: up to 24 months follow up, assessment every 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activities of daily living, instrumental
Time Frame: 24 months follow up, assesment every 6 months
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
Depression and mood
Time Frame: 24 months follow up, assesment every 6 months
CSDD: Cornell scale for depression in dementia, range 0-38, high score indicates high symptom load
24 months follow up, assesment every 6 months
Agitation
Time Frame: 24 months follow up, assesment every 6 months
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
Neuropsychiatric symptoms
Time Frame: 24 months follow up, assesment every 6 months
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
Adverse events
Time Frame: 24 months follow up, assesment every 6 months
Falls, disappearances outdoor, admissions to acute wards, fire hazard
24 months follow up, assesment every 6 months
Use of assistive technology
Time Frame: 24 months follow up, assesment every 6 months
number of technical aids, cognitive intervention devices and assisted-living systems
24 months follow up, assesment every 6 months
Use of volunteers
Time Frame: 24 months follow up, assesment every 6 months
number of participants with contact with a volunteer, number of hours spent with volunteer
24 months follow up, assesment every 6 months
Activities of daily living, personal
Time Frame: 24 months follow up, assesment every 6 months
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
Quality of Life
Time Frame: 24 months follow up, assesment every 6 months
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
Quality of Life VAS scale
Time Frame: 24 months follow up, assesment every 6 months
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
Quality of Life
Time Frame: 24 months follow up, assesment every 6 months
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
Use of volunteers
Time Frame: 24 months follow up, assesment every 6 months
number of hours spent with a volunteer
24 months follow up, assesment every 6 months
Change achieving
Time Frame: at the start of intervention, and every 6 months
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
Caregiver depression
Time Frame: 24 months follow up, assesment every 6 months
GDS: Geriatric depression scale, 30 items rated yeas or no, high score indicates high burden
24 months follow up, assesment every 6 months
Comorbidity
Time Frame: 24 months follow up, assesment every 6 months
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
Pain in dementia
Time Frame: 24 months follow up, assesment every 6 months
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
Change in cognitive performance
Time Frame: Baseline
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
Medication use
Time Frame: At the start of the intervention, and every 6 onth follow up
Self and proxy reported use of medications, both regular and on demand
At the start of the intervention, and every 6 onth follow up
Participation in educational programs
Time Frame: 24 months follow up, assessment every 6 months
Participation in educational programes, both for persons with dementia and for caregivers.
24 months follow up, assessment every 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID-19: risk perception
Time Frame: month 6 to month 12 (during COVID-19 lock down in Norway)
Caregivers perception of risk of contamination With Sars-Cov-10
month 6 to month 12 (during COVID-19 lock down in Norway)
COVID-19: restrictions
Time Frame: month 6 to month 12 (during COVID-19 lock down in Norway)
Change in services and contact due to restrictions of COVID-19
month 6 to month 12 (during COVID-19 lock down in Norway)
COVID-19: caregiver burden
Time Frame: month 6 to month 12 (during COVID-19 lock down in Norway)
Caregivers perception of caregiver burden during COVID-19
month 6 to month 12 (during COVID-19 lock down in Norway)
COVID-19: neuropsychiatric symptoms
Time Frame: month 6 to month 12 (during COVID-19 lock down in Norway)
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)
COVID-19: depression and mood
Time Frame: month 6 to month 12 (during COVID-19 lock down in Norway)
CSDD: Change in cornell scale for depression in dementia.
month 6 to month 12 (during COVID-19 lock down in Norway)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

King's College London
The University of Hong Kong
University College, London
Western Norway University of Applied Sciences
Tohoku University
Yale School of Medicine
Haraldsplass Deaconal Hospital
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
University of Leiden

Investigators

  • Principal Investigator: Bettina Husebø, MD, PhD, University of Bergen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

June 10, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFR 273581

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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