DementiaLIVENCT04043364
Live@Home.Path: Innovating the Clinical Pathway for Home Dwelling Persons With Dementia and Their Families
A study testing LIVE in people with Dementia and Home-dwelling, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Home-dwelling, Caregiver
- What is being tested?
- LIVE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteNorway
- Study dates
- 1 Aug 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Participate in other trials
- Expected survival under 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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).
- Conditions
- Dementia, Home-dwelling, Caregiver
- Being tested
- LIVE
- Keywords
- Learning, Innovation, Volunteers, Empowerment
- Medical subject headings
- Dementia, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIVEBehavioural
Learning, Innovation, Volunteers and Empowerment
| Study group | Role | What they receive |
|---|---|---|
| LIVE | Experimental | A multicomponent intervention focusing on Learning, Innovation, Volunteers and Empowerment organized by a local coordinator. Receives: Behavioral: LIVE |
| Treatment as usual | No intervention | Care coordination and facilitation as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: up to 24 months follow up, assessment every 6 months
Secondary outcomes (19)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 months follow up, assesment every 6 months
Adverse events
Falls, disappearances outdoor, admissions to acute wards, fire hazard
Measured: 24 months follow up, assesment every 6 months
Use of assistive technology
number of technical aids, cognitive intervention devices and assisted-living systems
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 months follow up, assesment every 6 months
Use of volunteers
number of hours spent with a volunteer
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline
Medication use
Self and proxy reported use of medications, both regular and on demand
Measured: 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.
Measured: 24 months follow up, assessment every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Aug 2019
- Primary completion10 Jun 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Mixed method, stepped wedge randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Bettina Husebø, MD, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043364
- Sponsor's protocol ID
- NFR 273581
- Acronym
- LIVE
- Status last verified
- Jan 2023
- First submitted
- 15 Mar 2019
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We plan to make individual participant data available to collaborators and researchers affiliated with the project.
Publications
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.
PubMed 32517727Gedde 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.
PubMed 33416012Angeles 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.
PubMed 34536149Puaschitz 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.
PubMed 34525979Vislapuu 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.
PubMed 34551783Husebo 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.
PubMed 32381282Husebo 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.
PubMed 32116687Gedde 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.
PubMed 32753339Faeo 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.
PubMed 31986964Faeo 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.
PubMed 33198779Faeo 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.
PubMed 31170916Gedde 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.
PubMed 35614509Berge 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.
PubMed 40042468Vislapuu 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.
PubMed 38550899Puaschitz 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.
PubMed 37284020
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04043364
- Acronym / sponsor ID
- LIVE / NFR 273581
- Conditions
- Dementia, Home-dwelling, Caregiver
- Keywords
- Learning, Innovation, Volunteers, Empowerment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed method, stepped wedge randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| LIVE | Experimental | Behavioral: LIVEA multicomponent intervention focusing on Learning, Innovation, Volunteers and Empowerment organized by a local coordinator. |
| Treatment as usual | No intervention | –Care coordination and facilitation as usual. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Participate in other trials
- Expected survival under 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIVELearning, Innovation, Volunteers and Empowerment | Behavioural | LIVE |
Primary outcome
Resource Utilization in Dementia
Time frame: 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
Time frame: 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
19 secondary outcomes
Activities of daily living, instrumental
Time frame: 24 months follow up, assesment every 6 months
Depression and mood
Time frame: 24 months follow up, assesment every 6 months
Agitation
Time frame: 24 months follow up, assesment every 6 months
Neuropsychiatric symptoms
Time frame: 24 months follow up, assesment every 6 months
Adverse events
Time frame: 24 months follow up, assesment every 6 months
Use of assistive technology
Time frame: 24 months follow up, assesment every 6 months
Use of volunteers
Time frame: 24 months follow up, assesment every 6 months
Activities of daily living, personal
Time frame: 24 months follow up, assesment every 6 months
Quality of Life
Time frame: 24 months follow up, assesment every 6 months
Quality of Life VAS scale
Time frame: 24 months follow up, assesment every 6 months
Quality of Life
Time frame: 24 months follow up, assesment every 6 months
Use of volunteers
Time frame: 24 months follow up, assesment every 6 months
Change achieving
Time frame: at the start of intervention, and every 6 months
Caregiver depression
Time frame: 24 months follow up, assesment every 6 months
Comorbidity
Time frame: 24 months follow up, assesment every 6 months
Pain in dementia
Time frame: 24 months follow up, assesment every 6 months
Change in cognitive performance
Time frame: Baseline
Medication use
Time frame: At the start of the intervention, and every 6 onth follow up
Participation in educational programs
Time frame: 24 months follow up, assessment every 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Background: PubMed 32517727Husebo 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.
- Background: PubMed 33416012Gedde 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.
- Background: PubMed 34536149Angeles 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.
- Background: PubMed 34525979Puaschitz 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.
- Background: PubMed 34551783Vislapuu 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.
- Background: PubMed 32381282Husebo 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.
- Background: PubMed 32116687Husebo 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.
- Background: PubMed 32753339Gedde 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.
- Background: PubMed 31986964Faeo 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.
- Background: PubMed 33198779Faeo 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.
- Background: PubMed 31170916Faeo 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.
- Background: PubMed 35614509Gedde 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.
- ProtocolLink provided by the sponsor.
- Access to and interest in assistive technology for home-dwelling people with dementia during the COVID-19 pandemic (PAN.DEM)Link provided by the sponsor.
- Which factors increase informal care hours and societal costs among caregivers of people with dementia? A systematic review of Resource Utilization in Dementia (RUD).Link provided by the sponsor.
- Factors associated with access to assistive technology and telecare in home-dwelling people with dementia: baseline data from the LIVE@Home.Path trialLink provided by the sponsor.
- The consequences of COVID-19 lockdown for formal and informal resource utilization among home-dwelling people with dementia: results from the prospective PAN.DEM studyLink provided by the sponsor.
- Intensive Medicine and Nursing Home Care in Times of SARS CoV-2: A Norwegian PerspectiveLink provided by the sponsor.
- Individual participant dataSharing planned: No. We plan to make individual participant data available to collaborators and researchers affiliated with the project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bettina Husebø, MD, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIVE in people with Dementia and Home-dwelling, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resource Utilization in Dementia (time frame: up to 24 months follow up, assesment every 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04043364, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.