Dementia, Home-dwelling, Caregiver
Conditions
Keywords
Learning, Innovation, Volunteers, Empowerment
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.
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).
Interventions
BEHAVIORALLIVE
Learning, Innovation, Volunteers and Empowerment
Sponsors
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 University
University College, London
University of Leiden
Tohoku University
King's College London
The University of Hong Kong
University of Bergen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Mixed method, stepped wedge randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Participation in educational programs | 24 months follow up, assessment every 6 months | Participation in educational programes, both for persons with dementia and for caregivers. |
| 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 |
| 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 |
| 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 |
| 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 |
| Adverse events | 24 months follow up, assesment every 6 months | Falls, disappearances outdoor, admissions to acute wards, fire hazard |
| Use of assistive technology | 24 months follow up, assesment every 6 months | number of technical aids, cognitive intervention devices and assisted-living systems |
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| COVID-19: caregiver burden | month 6 to month 12 (during COVID-19 lock down in Norway) | Caregivers perception of caregiver burden during COVID-19 |
| 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 |
| 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 |
Countries
Norway
Outcome results
None listed