NCT04043364

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 9, 2023

Status Verified

January 1, 2023

Enrollment Period

2.9 years

First QC Date

March 15, 2019

Last Update Submit

March 6, 2023

Conditions

DementiaHome-dwellingCaregiver

Keywords

LearningInnovationVolunteersEmpowerment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (19)

  • Activities of daily living, instrumental

    24 months follow up, assesment every 6 months

  • Depression and mood

    24 months follow up, assesment every 6 months

  • Agitation

    24 months follow up, assesment every 6 months

  • Neuropsychiatric symptoms

    24 months follow up, assesment every 6 months

  • Adverse events

    24 months follow up, assesment every 6 months

  • +14 more secondary outcomes

Other Outcomes (5)

  • COVID-19: risk perception

    month 6 to month 12 (during COVID-19 lock down in Norway)

  • COVID-19: restrictions

    month 6 to month 12 (during COVID-19 lock down in Norway)

  • COVID-19: caregiver burden

    month 6 to month 12 (during COVID-19 lock down in Norway)

  • +2 more other outcomes

Study Arms (2)

LIVE

EXPERIMENTAL

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

Behavioral: LIVE

Treatment as usual

NO INTERVENTION

Care coordination and facilitation as usual.

Interventions

LIVEBEHAVIORAL

Learning, Innovation, Volunteers and Empowerment

LIVE

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Participate in other trials
  • Expected survival under 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, 5009, Norway

Location

Related Publications (17)

  • Husebo BS, Allore H, Achterberg W, Angeles RC, Ballard C, Bruvik FK, Faeo SE, Gedde MH, Hillestad E, Jacobsen FF, Kirkevold O, Kjerstad E, Kjome RLS, Mannseth J, Naik M, Nouchi R, Puaschitz N, Samdal R, Tranvag O, Tzoulis C, Vahia IV, Vislapuu M, Berge LI. LIVE@Home.Path-innovating the clinical pathway for home-dwelling people with dementia and their caregivers: study protocol for a mixed-method, stepped-wedge, randomized controlled trial. Trials. 2020 Jun 9;21(1):510. doi: 10.1186/s13063-020-04414-y.

    PMID: 32517727BACKGROUND

  • Gedde MH, Husebo BS, Erdal A, Puaschitz NG, Vislapuu M, Angeles RC, Berge LI. Access to and interest in assistive technology for home-dwelling people with dementia during the COVID-19 pandemic (PAN.DEM). Int Rev Psychiatry. 2021 Jun;33(4):404-411. doi: 10.1080/09540261.2020.1845620. Epub 2021 Jan 8.

    PMID: 33416012BACKGROUND

  • Angeles RC, Berge LI, Gedde MH, Kjerstad E, Vislapuu M, Puaschitz NG, Husebo BS. Which factors increase informal care hours and societal costs among caregivers of people with dementia? A systematic review of Resource Utilization in Dementia (RUD). Health Econ Rev. 2021 Sep 18;11(1):37. doi: 10.1186/s13561-021-00333-z.

    PMID: 34536149BACKGROUND

  • Puaschitz NG, Jacobsen FF, Mannseth J, Angeles RC, Berge LI, Gedde MH, Husebo BS. Factors associated with access to assistive technology and telecare in home-dwelling people with dementia: baseline data from the LIVE@Home.Path trial. BMC Med Inform Decis Mak. 2021 Sep 15;21(1):264. doi: 10.1186/s12911-021-01627-2.

    PMID: 34525979BACKGROUND

  • Vislapuu M, Angeles RC, Berge LI, Kjerstad E, Gedde MH, Husebo BS. The consequences of COVID-19 lockdown for formal and informal resource utilization among home-dwelling people with dementia: results from the prospective PAN.DEM study. BMC Health Serv Res. 2021 Sep 22;21(1):1003. doi: 10.1186/s12913-021-07041-8.

    PMID: 34551783BACKGROUND

  • Husebo BS, Berge LI. Intensive Medicine and Nursing Home Care in Times of SARS CoV-2: A Norwegian Perspective. Am J Geriatr Psychiatry. 2020 Jul;28(7):792-793. doi: 10.1016/j.jagp.2020.04.016. Epub 2020 Apr 22. No abstract available.

    PMID: 32381282BACKGROUND

  • Husebo BS, Heintz HL, Berge LI, Owoyemi P, Rahman AT, Vahia IV. Sensing Technology to Monitor Behavioral and Psychological Symptoms and to Assess Treatment Response in People With Dementia. A Systematic Review. Front Pharmacol. 2020 Feb 4;10:1699. doi: 10.3389/fphar.2019.01699. eCollection 2019.

    PMID: 32116687BACKGROUND

  • Gedde MH, Husebo BS, Mannseth J, Kjome RLS, Naik M, Berge LI. Less Is More: The Impact of Deprescribing Psychotropic Drugs on Behavioral and Psychological Symptoms and Daily Functioning in Nursing Home Patients. Results From the Cluster-Randomized Controlled COSMOS Trial. Am J Geriatr Psychiatry. 2021 Mar;29(3):304-315. doi: 10.1016/j.jagp.2020.07.004. Epub 2020 Jul 11.

    PMID: 32753339BACKGROUND

  • Faeo SE, Bruvik FK, Tranvag O, Husebo BS. Home-dwelling persons with dementia's perception on care support: Qualitative study. Nurs Ethics. 2020 Jun;27(4):991-1002. doi: 10.1177/0969733019893098. Epub 2020 Jan 27.

    PMID: 31986964BACKGROUND

  • Faeo SE, Tranvag O, Samdal R, Husebo BS, Bruvik FK. The compound role of a coordinator for home-dwelling persons with dementia and their informal caregivers: qualitative study. BMC Health Serv Res. 2020 Nov 16;20(1):1045. doi: 10.1186/s12913-020-05913-z.

    PMID: 33198779BACKGROUND

  • Faeo SE, Husebo BS, Bruvik FK, Tranvag O. "We live as good a life as we can, in the situation we're in" - the significance of the home as perceived by persons with dementia. BMC Geriatr. 2019 Jun 6;19(1):158. doi: 10.1186/s12877-019-1171-6.

    PMID: 31170916BACKGROUND

  • Gedde MH, Husebo BS, Mannseth J, Naik M, Selbaek G, Vislapuu M, Berge LI. The impact of medication reviews by general practitioners on psychotropic drug use and behavioral and psychological symptoms in home-dwelling people with dementia: results from the multicomponent cluster randomized controlled LIVE@Home.Path trial. BMC Med. 2022 May 26;20(1):186. doi: 10.1186/s12916-022-02382-5.

    PMID: 35614509BACKGROUND

  • Berge LI, Angeles RC, Gedde MH, Faeo SE, Mannseth J, Vislapuu M, Soyland Puaschitz NG, Hillestad E, Aarsland D, Achterberg WP, Allore H, Ballard C, Li F, Selbaek G, Vahia IV, Husebo BS. Burden and care time for dementia caregivers in the LIVE@Home.Path trial. Alzheimers Dement. 2025 Mar;21(3):e14622. doi: 10.1002/alz.14622.

    PMID: 40042468DERIVED

  • Vislapuu M, Patrascu M, Allore H, Husebo BS, Kjerstad E, Gedde MH, Berge LI. Feedback System Analysis of a Multicomponent Intervention on Dyads of Home-Dwelling Persons With Dementia and Their Caregivers: Results From the LIVE@Home.Path Trial. Innov Aging. 2024 Feb 23;8(3):igae020. doi: 10.1093/geroni/igae020. eCollection 2024.

    PMID: 38550899DERIVED

  • Puaschitz NGS, Jacobsen FF, Berge LI, Husebo BS. Access to, use of, and experiences with social alarms in home-living people with dementia: results from the LIVE@Home.Path trial. Front Aging Neurosci. 2023 May 22;15:1167616. doi: 10.3389/fnagi.2023.1167616. eCollection 2023.

    PMID: 37284020DERIVED

  • Berge LI, Gedde MH, Torrado Vidal JC, Husebo B, Hynninen KM, Knardal SE, Madso KG. The acceptability, adoption, and feasibility of a music application developed using participatory design for home-dwelling persons with dementia and their caregivers. The "Alight" app in the LIVE@Home.Path trial. Front Psychiatry. 2022 Aug 18;13:949393. doi: 10.3389/fpsyt.2022.949393. eCollection 2022.

    PMID: 36061298DERIVED

  • Gedde MH, Husebo BS, Vahia IV, Mannseth J, Vislapuu M, Naik M, Berge LI. Impact of COVID-19 restrictions on behavioural and psychological symptoms in home-dwelling people with dementia: a prospective cohort study (PAN.DEM). BMJ Open. 2022 Jan 24;12(1):e050628. doi: 10.1136/bmjopen-2021-050628.

    PMID: 35074810DERIVED

Related Links

MeSH Terms

Conditions

DementiaEmpowerment

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Bettina Husebø, MD, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Mixed method, stepped wedge randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2019

First Posted

August 2, 2019

Study Start

August 1, 2019

Primary Completion

June 10, 2022

Study Completion

December 31, 2023

Last Updated

March 9, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

We plan to make individual participant data available to collaborators and researchers affiliated with the project.

Locations

NO(1)