NCT05658666

Brief 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.

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
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

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

November 29, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

December 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

December 22, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

November 29, 2022

Last Update Submit

December 21, 2022

Conditions

DementiaNursing Home ResidentChallenging Behavior

Keywords

Video Feedback InterventionDementiaChallenging behaviorNursing home

Outcome Measures

Primary Outcomes (1)

  • Changes in sense of competence of the professional caregiver

    Sense of competence in dementia care scale (SCIDS)

    5 months

Secondary Outcomes (8)

  • Professional caregiver measures: changes in strain in dementia work

    5 months

  • Professional caregiver measures: changes in safety in team participation

    5 months

  • Loved ones measures: changes in sense of competence

    5 months

  • Person with dementia: changes in frequency of psychopathology

    5 months

  • Person with dementia: changes in severity of psychopathology

    5 months

  • +3 more secondary outcomes

Other Outcomes (10)

  • Professional caregiver measures: Changes in quality of communication with the person with dementia

    5 months

  • Professional caregiver measures: changes in quality of relationship with the person with dementia

    5 months

  • Professional caregiver measures: changes in emotional strain

    5 months

  • +7 more other outcomes

Interventions

Video feedback intervention (in Dutch: Video Interventie Ouderenzorg)BEHAVIORAL

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Nursing home resident
  • Dementia
  • Severe challenging behavior
  • Video feedback intervention is started by health care professionals as part of usual care

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Expertise Centrum VIO de Wever, behandelcentrum de Hazelaar

Tilburg, North Brabant, 5042 SE, Netherlands

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Debby Gerritsen

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Debby Gerritsen

CONTACT

+31243618181debby.gerritsen@radboudumc.nl

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 21, 2022

Study Start

December 13, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

December 22, 2022

Record last verified: 2022-08

Locations

NL(1)