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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05658666
Other study ID # 111972
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 13, 2022
Est. completion date June 1, 2024

Study information

Verified date August 2022
Source Radboud University Medical Center
Contact Debby Gerritsen
Phone +31243618181
Email debby.gerritsen@radboudumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Netherlands Expertise Centrum VIO de Wever, behandelcentrum de Hazelaar Tilburg Noord-Brabant

Sponsors (2)

Lead Sponsor Collaborator
Radboud University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Professional caregiver measures: Changes in quality of communication with the person with dementia self-developed items 5 months
Other Professional caregiver measures: changes in quality of relationship with the person with dementia self-developed items 5 months
Other Professional caregiver measures: changes in emotional strain self-developed items 5 months
Other Loved ones measures: Changes in quality of communication with the person with dementia self-developed items 5 months
Other Loved ones measures: Changes in quality of relationship with the person with dementia self-developed items 5 months
Other Loved ones measures: Changes in emotional strain self-developed items 5 months
Other Loved ones measures: Changes in life satisfaction self-developed items 5 months
Other Care team measures: changes in succesful communication with the person with dementia succesful communication scheme 5 months
Other Care team measures: changes in attunement with the person with dementia relational attunement scheme 5 months
Other Care team measures: Changes in sense of competence of the care team as a whole Analysis team learning scale 5 months
Primary Changes in sense of competence of the professional caregiver Sense of competence in dementia care scale (SCIDS) 5 months
Secondary Professional caregiver measures: changes in strain in dementia work Strain in dementia care scale (SDC) 5 months
Secondary Professional caregiver measures: changes in safety in team participation Team climate inventory (TCI) 5 months
Secondary Loved ones measures: changes in sense of competence Short sense of competence questionnaire (SSCQ) 5 months
Secondary Person with dementia: changes in frequency of psychopathology Neuropsychiatric inventory nursing home (NPI-NH) 5 months
Secondary Person with dementia: changes in severity of psychopathology Neuropsychiatric inventory nursing home (NPI-NH) 5 months
Secondary Person with dementia: changes in frequency of agitated behaviors Cohen Mansfield Agitation Inventory (CMAI) 5 months
Secondary Person with dementia: changes in quality of life Quality of life - Alzheimer Disease Scale (QOL-AD) 5 months
Secondary Person with dementia: changes in social well-being Revised index for social engagement (RISE) 5 months
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