- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05065281
Responding to Elder Abuse in GERiAtric Care: Educational Intervention (REAGERA edu)
Responding to Elder Abuse in GERiAtric Care Educational Intervention for Healthcare Providers: a Non-randomised Stepped Wedge Trial.
The prevalence of elder abuse has been reported between 10-15% in international studies. Elder abuse may include both physical, emotional, sexual and financial abuse as well as neglect and it occurs at the hand of both professionals and family members, including adult children and intimate partners. Elder abuse has been associated with psychological ill-health, disability, increased hospitalization, emergency department use and admission to nursing facilities. Elder abuse is however often unknown to health care providers. Older adults are hesitant to disclose abuse and health care providers are often reluctant to ask questions.
In this study an interactive educational model for health care professionals about elder abuse will be tested. The model consist of theoretical lectures, brief films showing patient encounters, group discussions and forum play, a form of participatory theater. Both group discussions and forum play will be using case scenarios as a cornerstone.
The validated questionnaire REAGERA-P will be used for self-reported measures
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Eksjö, Sweden
- Region Jönköpings län
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Jönköping, Sweden
- Region Jönköpings län
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Linköping, Sweden
- Region Östergötland
-
Norrköping, Sweden
- Region Östergötland
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Employee at one of the clinics participating in the trial
- Work tasks involves direct patient contact, at least part time
- Participation at the training sessions
Exclusion Criteria:
- Only administrative work and no direct patient contact
- Not participating at the training session
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Education
Participants that have undergone the educational intervention
|
Training for health care professionals on how to identify and manage cases of elder abuse among their patients
|
|
No Intervention: Waitlist
Participants still waiting to cross over to intervention arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change between baseline and follow up concerning asking questions about abuse, as reported in the questionnaire REAGERA-P
Time Frame: Baseline, 6 month follow up, 12 month follow up
|
Self-report measure of asking older patients about abusive experience.
Will be measure both as a dichotomous value (have ever asked questions during the last 6 months) as well as a frequency measure where participants report how often they have asked patients questions about abuse during the last 6 months (on a scale from 0 to 10 or more)
|
Baseline, 6 month follow up, 12 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change between baseline and follow up concerning awareness of elder abuse and sense of responsibility for identifying victims, as reported in the questionnaire REAGERA-P
Time Frame: Baseline, Immediate post-intervention (number 2), 6 month follow up, 12 month follow up
|
|
Baseline, Immediate post-intervention (number 2), 6 month follow up, 12 month follow up
|
|
Change between baseline and follow up concerning level of awareness of abuse in contact with patients, as reported in the questionnaire REAGERA-P
Time Frame: Baseline, 6 or 12 month follow up (different for different clusters)
|
Patient case ("Vignette") with indicators of abuse and participants self-report if they think they would have asked the patient questions about abuse
|
Baseline, 6 or 12 month follow up (different for different clusters)
|
|
Change between baseline and follow up concerning perceived ability to ask questions about abuse, as reported in REAGERA-P
Time Frame: Baseline, Immediate post-intervention, 6 month follow up, 12 month follow up
|
|
Baseline, Immediate post-intervention, 6 month follow up, 12 month follow up
|
|
Change between baseline and follow up concerning perceived preparedness to manage cases of elder abuse, as reported in REAGERA-P
Time Frame: Baseline, Immediate post-intervention (number 1and 2), 6 months follow up, 12 months follow up
|
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Baseline, Immediate post-intervention (number 1and 2), 6 months follow up, 12 months follow up
|
|
Change between baseline and follow up concerning preparedness at the clinic to care for older adults subjected to abuse, as reported in REAGERA-P
Time Frame: Baseline, 6 months follow up, 12 months follow up
|
Self-reported evaluation of:
|
Baseline, 6 months follow up, 12 months follow up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change between baseline and follow up concerning number of elder abuse victims identified at the clinics included in the study, as reported in the medical records
Time Frame: Baseline, 6 month follow up, 12 month follow up
|
Anonymous data from the medical records counting the number of older patients treated at each clinic that have been identified as victims of abuse during the last 6 months
|
Baseline, 6 month follow up, 12 month follow up
|
|
Change between baseline and follow up concerning adequate follow up, as reported in the questionnaire REAGERA-P
Time Frame: Baseline, 6 month follow up, 12 month follow up
|
Frequency of respondents reporting that identified cases of elder abuse were given adequate follow up
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Baseline, 6 month follow up, 12 month follow up
|
|
Change between baseline and follow up concerning self-reported hesitancy for asking questions about elder abuse, as reported in the questionnaire REAGERA-P
Time Frame: Baseline, 6 month follow up, 12 month follow up
|
Frequency of respondents reporting that they have suspected cases of elder abuse but refrained from asking questions
|
Baseline, 6 month follow up, 12 month follow up
|
|
Degree of changed practice as reported in the questionnaire REAGERA-P
Time Frame: 6 month follow up
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Frequency of participants self-reporting that they have changed their working practices as a result of the educational intervention
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6 month follow up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Johanna Simmons, MD, PhD, Region Östergötland
Publications and helpful links
General Publications
- Simmons J, Wenemark M, Ludvigsson M. Development and validation of REAGERA-P, a new questionnaire to evaluate health care provider preparedness to identify and manage elder abuse. BMC Health Serv Res. 2021 May 19;21(1):473. doi: 10.1186/s12913-021-06469-2.
- Ludvigsson M, Motamedi A, Westerlind B, Swahnberg K, Simmons J. Responding to Elder Abuse in GERiAtric care (REAGERA) educational intervention for healthcare providers: a non-randomised stepped wedge trial. BMJ Open. 2022 May 4;12(5):e060314. doi: 10.1136/bmjopen-2021-060314.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RÖ-786
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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