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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Dementia, Home-dwelling, Caregiver

Intervention / Treatment
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* Behavioral: LIVE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Home-dwelling people with dementia (PWD) equal or above 65 years diagnosed according to national guidelines Mini mental state examination score 15-24 Functional Assessment Staging Test (FAST score 4-7) Living with a partner, or have regular contact with a caregiver minimum 1 hour/week Exclusion Criteria: Participate in other trials Expected survival under 4 weeks

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Mixed method, stepped wedge randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | up to 24 months follow up, assessment every 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 24 months follow up, assesment every 6 months | 
| Adverse events | Falls, disappearances outdoor, admissions to acute wards, fire hazard | 24 months follow up, assesment every 6 months | 
| Use of assistive technology | number of technical aids, cognitive intervention devices and assisted-living systems | 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 | 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 | 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 | 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 | 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 | 24 months follow up, assesment every 6 months | 
| Use of volunteers | number of hours spent with a volunteer | 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. | 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 | 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 | 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 | 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 | Baseline | 
| Medication use | 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 | Participation in educational programes, both for persons with dementia and for caregivers. | 24 months follow up, assessment every 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Learning, Innovation, Volunteers, Empowerment