- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05658666
Video Feedback Intervention in Nursing Home Residents With Dementia and Severe Challenging Behavior.
December 21, 2022 updated by: Radboud University Medical Center
Leren Zien Wat Werkt: Video Interventie Ouderenzorg (VIO) Bij cliënten Met Dementie en Ernstig Probleemgedrag in Verpleeghuizen.
The purpose of this study is to evaluate how, under what circumstances and for whom the video feedback intervention works for (the caregivers of) people with dementia and severe challenging behavior in a nursing home setting.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This mixed multiple case study focuses on the evaluation of a video feedback intervention for (the caregivers of) people with dementia and challenging behavior.
The video feedback intervention focuses on understanding the person with dementia, increasing the sense of competence in caregivers and improving their communication skills when interacting with the person with dementia.
This realist evaluation aims to investigate what outcomes the intervention generates, for whom and in which contexts.
Participants will receive care as usual.
Study Type
Observational
Enrollment (Anticipated)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Debby Gerritsen
- Phone Number: +31243618181
- Email: debby.gerritsen@radboudumc.nl
Study Locations
-
-
Noord-Brabant
-
Tilburg, Noord-Brabant, Netherlands, 5042 SE
- Recruiting
- Expertise Centrum VIO de Wever, behandelcentrum de Hazelaar
-
Contact:
- Inge Hageman, MA
- Phone Number: 00316-18 72 75 88
- Email: i.hageman@dewever.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- Nursing home residents with dementia and severe challenging behavior where video feedback intervention is started by health care professionals as part of usual care.
- Family caregivers of these nursing home resident
- Involded professional caregivers
Description
Inclusion Criteria:
- Nursing home resident
- Dementia
- Severe challenging behavior
- Video feedback intervention is started by health care professionals as part of usual care
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in sense of competence of the professional caregiver
Time Frame: 5 months
|
Sense of competence in dementia care scale (SCIDS)
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Professional caregiver measures: changes in strain in dementia work
Time Frame: 5 months
|
Strain in dementia care scale (SDC)
|
5 months
|
|
Professional caregiver measures: changes in safety in team participation
Time Frame: 5 months
|
Team climate inventory (TCI)
|
5 months
|
|
Loved ones measures: changes in sense of competence
Time Frame: 5 months
|
Short sense of competence questionnaire (SSCQ)
|
5 months
|
|
Person with dementia: changes in frequency of psychopathology
Time Frame: 5 months
|
Neuropsychiatric inventory nursing home (NPI-NH)
|
5 months
|
|
Person with dementia: changes in severity of psychopathology
Time Frame: 5 months
|
Neuropsychiatric inventory nursing home (NPI-NH)
|
5 months
|
|
Person with dementia: changes in frequency of agitated behaviors
Time Frame: 5 months
|
Cohen Mansfield Agitation Inventory (CMAI)
|
5 months
|
|
Person with dementia: changes in quality of life
Time Frame: 5 months
|
Quality of life - Alzheimer Disease Scale (QOL-AD)
|
5 months
|
|
Person with dementia: changes in social well-being
Time Frame: 5 months
|
Revised index for social engagement (RISE)
|
5 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Professional caregiver measures: Changes in quality of communication with the person with dementia
Time Frame: 5 months
|
self-developed items
|
5 months
|
|
Professional caregiver measures: changes in quality of relationship with the person with dementia
Time Frame: 5 months
|
self-developed items
|
5 months
|
|
Professional caregiver measures: changes in emotional strain
Time Frame: 5 months
|
self-developed items
|
5 months
|
|
Loved ones measures: Changes in quality of communication with the person with dementia
Time Frame: 5 months
|
self-developed items
|
5 months
|
|
Loved ones measures: Changes in quality of relationship with the person with dementia
Time Frame: 5 months
|
self-developed items
|
5 months
|
|
Loved ones measures: Changes in emotional strain
Time Frame: 5 months
|
self-developed items
|
5 months
|
|
Loved ones measures: Changes in life satisfaction
Time Frame: 5 months
|
self-developed items
|
5 months
|
|
Care team measures: changes in succesful communication with the person with dementia
Time Frame: 5 months
|
succesful communication scheme
|
5 months
|
|
Care team measures: changes in attunement with the person with dementia
Time Frame: 5 months
|
relational attunement scheme
|
5 months
|
|
Care team measures: Changes in sense of competence of the care team as a whole
Time Frame: 5 months
|
Analysis team learning scale
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Debby Gerritsen, Radboud University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2022
Primary Completion (Anticipated)
June 1, 2024
Study Completion (Anticipated)
June 1, 2024
Study Registration Dates
First Submitted
November 29, 2022
First Submitted That Met QC Criteria
December 13, 2022
First Posted (Actual)
December 21, 2022
Study Record Updates
Last Update Posted (Estimate)
December 22, 2022
Last Update Submitted That Met QC Criteria
December 21, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111972
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dementia
-
Benjamin Rose Institute on AgingNational Institute on Aging (NIA)RecruitingMild Dementia | Moderate DementiaUnited States
-
Yaolin PeiNational Institutes of Health (NIH)RecruitingEnd of Life Decision Making | Dementia Caregivers | Advanced DementiaUnited States
-
Benuvia Therapeutics Inc.MandaraNot yet recruiting
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityCompletedDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeActive, not recruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
Temple UniversityCompletedDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
The University of Hong KongNot yet recruiting
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
Clinical Trials on Video feedback intervention (in Dutch: Video Interventie Ouderenzorg)
-
McMaster UniversityCompleted
-
IRCCS Eugenio MedeaUniversità degli Studi di Brescia; Fondazione Istituto Neurologico Casimiro...CompletedParent-Child Relations | Developmental Disability | Early Intervention | EpigenomicsItaly
-
University of IowaEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
Universidad de ValparaisoPontificia Universidad Catolica de Chile; University of ChileCompleted
-
China National Center for Cardiovascular DiseasesNot yet recruitingEducation | Cardiac | Surgery (Cardiac) | Artificial Intelligence (AI)China
-
IRCCS National Neurological Institute "C. Mondino...RecruitingNeurodevelopmental DisordersItaly
-
University of BarcelonaEnrolling by invitationAutism Spectrum Disorder (ASD | Parental BehaviorsSpain
-
Express CollaborativeCanadian Institutes of Health Research (CIHR); Heart and Stroke Foundation...CompletedCardiac ArrestUnited States, Canada, United Kingdom
-
Pontificia Universidad Catolica de ChileInstituto Milenio para Investigación en Depresión y PersonalidadCompletedDepressive Symptoms | Parent-Child RelationsChile