[e-mail]: Innovating the Clinical Pathway for Home Dwelling Persons With Dementia and Their Families (LIVE)

University of Bergen

Status: Active, not recruiting

Conditions: Home-dwelling; Caregiver; Dementia

Treatments: Behavioral: LIVE

Study type: Interventional

Funder types: Other

Identifiers

NCT04043364

NFR 273581

Details and patient eligibility

About

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.

Full 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 [e-mail] 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 [e-mail] 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).

Enrollment: 280 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

280 participants in 2 patient groups

LIVE

Experimental group

Description:

A multicomponent intervention focusing on Learning, Innovation, Volunteers and Empowerment organized by a local coordinator.

Treatment:

Behavioral: LIVE

Treatment as usual

No Intervention group

Description:

Care coordination and facilitation as usual.