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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
280
Learning, Innovation, Volunteers and Empowerment
University of Bergen
Bergen, Norway
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
Time frame: up to 24 months follow up, assesment every 6 months
Relative stress scale
RSS: measuring caregiver distress, 15 items ranging from 0-4, high score indicates high burden
Time frame: up to 24 months follow up, assessment every 6 months
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
Time frame: 24 months follow up, assesment every 6 months
Depression and mood
CSDD: Cornell scale for depression in dementia, range 0-38, high score indicates high symptom load
Time frame: 24 months follow up, assesment every 6 months
Agitation
CMAI: Cohen-Mansfield Agitation Inventory, 29 items assessing the frequency of agitated behaviour, range 29-203, high score indicates higher severity
Time frame: 24 months follow up, assesment every 6 months
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
Time frame: 24 months follow up, assesment every 6 months
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Adverse events
Falls, disappearances outdoor, admissions to acute wards, fire hazard
Time frame: 24 months follow up, assesment every 6 months
Use of assistive technology
number of technical aids, cognitive intervention devices and assisted-living systems
Time frame: 24 months follow up, assesment every 6 months
Use of volunteers
number of participants with contact with a volunteer, number of hours spent with volunteer
Time frame: 24 months follow up, assesment every 6 months
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
Time frame: 24 months follow up, assesment every 6 months
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
Time frame: 24 months follow up, assesment every 6 months
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
Time frame: 24 months follow up, assesment every 6 months
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
Time frame: 24 months follow up, assesment every 6 months
Use of volunteers
number of hours spent with a volunteer
Time frame: 24 months follow up, assesment every 6 months
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.
Time frame: at the start of intervention, and every 6 months
Caregiver depression
GDS: Geriatric depression scale, 30 items rated yeas or no, high score indicates high burden
Time frame: 24 months follow up, assesment every 6 months
Comorbidity
GMHR: General medical health rating scale, 4 point likert scale, range from 1-4, high score indicates high comorbidity burden
Time frame: 24 months follow up, assesment every 6 months
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
Time frame: 24 months follow up, assesment every 6 months
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
Time frame: Baseline
Medication use
Self and proxy reported use of medications, both regular and on demand
Time frame: At the start of the intervention, and every 6 onth follow up
Participation in educational programs
Participation in educational programes, both for persons with dementia and for caregivers.
Time frame: 24 months follow up, assessment every 6 months