DementiaNCT05658666
Video Feedback Intervention in Nursing Home Residents With Dementia and Severe Challenging Behavior.
An observational study of Dementia and Nursing Home Resident, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Nursing Home Resident, Challenging Behavior
- What is being tested?
- Video feedback intervention (in Dutch: Video Interventie Ouderenzorg)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Dec 2022to 1 Jun 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Nursing home resident
- Dementia
- Severe challenging behavior
- Video feedback intervention is started by health care professionals as part of usual care
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Expertise Centrum VIO de Wever, behandelcentrum de Hazelaar
Tilburg, North Brabant, 5042 SE
Inge Hageman, MA, 00316-18 72 75 88, i.hageman@dewever.nl
About this study
Official title: 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.
Read the 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.
- Conditions
- Dementia, Nursing Home Resident, Challenging Behavior
- Being tested
- Video feedback intervention (in Dutch: Video Interventie Ouderenzorg)
- Keywords
- Video Feedback Intervention, Dementia, Challenging behavior, Nursing home
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video feedback intervention (in Dutch: Video Interventie Ouderenzorg)Behavioural
The video feedback trainer assesses the interaction between the person with dementia and the caregiver and acquires agreement from the caregiver on the goals of the intervention. Caregivers are trained during several feedback sessions using personal video footage of interaction between the person with dementia and the caregiver. The feedback focuses on basic interaction and attunement principles, and the team feeling competent. Recording starts with a nondemanding situation, enabling the caregiver to become aware of the principles they already apply and to learn how these principles can be used in more demanding situations. Subsequently, video footage is recorded in 1 to 3 situations, depending on the progress, of increasing difficulty, with about 4 weeks between 2 recordings. After each recording, a 1-hour feedback session is held. The intervention concludes with separate, 30-minute sessions for the formal and informal caregivers evaluating the intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sense of competence of the professional caregiver
Sense of competence in dementia care scale (SCIDS)
Measured: 5 months
Secondary outcomes (8)
Professional caregiver measures: changes in strain in dementia work
Strain in dementia care scale (SDC)
Measured: 5 months
Professional caregiver measures: changes in safety in team participation
Team climate inventory (TCI)
Measured: 5 months
Loved ones measures: changes in sense of competence
Short sense of competence questionnaire (SSCQ)
Measured: 5 months
Person with dementia: changes in frequency of psychopathology
Neuropsychiatric inventory nursing home (NPI-NH)
Measured: 5 months
Person with dementia: changes in severity of psychopathology
Neuropsychiatric inventory nursing home (NPI-NH)
Measured: 5 months
Person with dementia: changes in frequency of agitated behaviors
Cohen Mansfield Agitation Inventory (CMAI)
Measured: 5 months
Person with dementia: changes in quality of life
Quality of life - Alzheimer Disease Scale (QOL-AD)
Measured: 5 months
Person with dementia: changes in social well-being
Revised index for social engagement (RISE)
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start13 Dec 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Debby Gerritsen, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658666
- Sponsor's protocol ID
- 111972
- Status last verified
- Aug 2022
- First submitted
- 29 Nov 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leren Zien Wat Werkt: Video Interventie Ouderenzorg (VIO) Bij cliënten Met Dementie en Ernstig Probleemgedrag in Verpleeghuizen.
- ClinicalTrials.gov ID
- NCT05658666
- Acronym / sponsor ID
- 111972
- Conditions
- Dementia, Nursing Home Resident, Challenging Behavior
- Keywords
- Video Feedback Intervention, Dementia, Challenging behavior, Nursing home
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 21 Dec 2022 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Nursing home resident
- Dementia
- Severe challenging behavior
- Video feedback intervention is started by health care professionals as part of usual care
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Video feedback intervention (in Dutch: Video Interventie Ouderenzorg)The video feedback trainer assesses the interaction between the person with dementia and the caregiver and acquires agreement from the caregiver on the goals of the intervention. Caregivers are trained during several feedback sessions using personal video footage of interaction between the person with dementia and the caregiver. The feedback focuses on basic interaction and attunement principles, and the team feeling competent. Recording starts with a nondemanding situation, enabling the caregiver to become aware of the principles they already apply and to learn how these principles can be used in more demanding situations. Subsequently, video footage is recorded in 1 to 3 situations, depending on the progress, of increasing difficulty, with about 4 weeks between 2 recordings. After each recording, a 1-hour feedback session is held. The intervention concludes with separate, 30-minute sessions for the formal and informal caregivers evaluating the intervention. | Behavioural | – |
Primary outcome
Changes in sense of competence of the professional caregiver
Time frame: 5 months
Sense of competence in dementia care scale (SCIDS)
8 secondary outcomes
Professional caregiver measures: changes in strain in dementia work
Time frame: 5 months
Professional caregiver measures: changes in safety in team participation
Time frame: 5 months
Loved ones measures: changes in sense of competence
Time frame: 5 months
Person with dementia: changes in frequency of psychopathology
Time frame: 5 months
Person with dementia: changes in severity of psychopathology
Time frame: 5 months
Person with dementia: changes in frequency of agitated behaviors
Time frame: 5 months
Person with dementia: changes in quality of life
Time frame: 5 months
Person with dementia: changes in social well-being
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
Debby Gerritsen principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Nursing Home Resident, run by Radboud University Medical Center at 1 site in Netherlands.
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 1 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 22 Dec 2022. 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 Netherlands. 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?
Contact Debby Gerritsen (+31243618181, debby.gerritsen@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sense of competence of the professional caregiver (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2022.