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

Sponsor
University of Bergen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04043364
Collaborator
Haraldsplass Deaconal Hospital (Other), Western Norway University of Applied Sciences (Other), Norwegian Reseach Centre AS (NORCE) (Other), Norwegian National Advisory Unit on Ageing and Health (Other), Natioal Association for Public Health (Other), Municipality of Bergen (Other), Municipally of Kristiansund (Other), Municipally of Bærum (Other), The Dignity Centre (Other), Harvard McLean University (Other), Yale School of Medicine (Other), University College, London (Other), University of Leiden (Other), Tohoku University (Other), King's College London (Other), The University of Hong Kong (Other)
280
Enrollment
1
Location
2
Arms
41
Anticipated Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: LIVE
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
Mixed method, stepped wedge randomized controlled trialMixed 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 :
Aug 1, 2019
Actual Primary Completion Date :
Jun 10, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Resource Utilization in Dementia [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 [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 [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 [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 [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 [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 [24 months follow up, assesment every 6 months]

    Falls, disappearances outdoor, admissions to acute wards, fire hazard

  6. Use of assistive technology [24 months follow up, assesment every 6 months]

    number of technical aids, cognitive intervention devices and assisted-living systems

  7. Use of volunteers [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 [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 [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 [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 [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 [24 months follow up, assesment every 6 months]

    number of hours spent with a volunteer

  13. Change achieving [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [month 6 to month 12 (during COVID-19 lock down in Norway)]

    CSDD: Change in cornell scale for depression in dementia.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
University of Bergen
ClinicalTrials.gov Identifier:
NCT04043364
Other Study ID Numbers:
  • NFR 273581
First Posted:
Aug 2, 2019
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Dementia

Study Results

No Results Posted as of Jun 16, 2022