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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04043364
Recruitment Status : Active, not recruiting
First Posted : August 2, 2019
Last Update Posted : June 16, 2022
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
University of Bergen

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.

Condition or disease Intervention/treatment Phase
Dementia Home-dwelling Caregiver Behavioral: LIVE Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Mixed method, stepped wedge randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : June 10, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Adverse events [ Time Frame: 24 months follow up, assesment every 6 months ]
    Falls, disappearances outdoor, admissions to acute wards, fire hazard

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. Use of volunteers [ Time Frame: 24 months follow up, assesment every 6 months ]
    number of hours spent with a volunteer

  13. 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.

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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.


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043364


Locations
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Norway
University of Bergen
Bergen, Norway, 5009
Sponsors and Collaborators
University of Bergen
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
Investigators
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Principal Investigator: Bettina Husebø, MD, PhD University of Bergen
Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Bergen
ClinicalTrials.gov Identifier: NCT04043364    
Other Study ID Numbers: NFR 273581
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We plan to make individual participant data available to collaborators and researchers affiliated with the project.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Bergen:
Learning
Innovation
Volunteers
Empowerment
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders