NCT05065281

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
554

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

4 active sites

Status
completed

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

September 15, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

September 16, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2024

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

3.2 years

First QC Date

September 15, 2021

Last Update Submit

December 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change between baseline and follow up concerning asking questions about abuse, as reported in the questionnaire REAGERA-P

    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 Outcomes (5)

  • 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

    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

    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

    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

    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

    Baseline, 6 months follow up, 12 months follow up

Other Outcomes (4)

  • 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

    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

    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

    Baseline, 6 month follow up, 12 month follow up

  • +1 more other outcomes

Study Arms (2)

Education

EXPERIMENTAL

Participants that have undergone the educational intervention

Other: Education

Waitlist

NO INTERVENTION

Participants still waiting to cross over to intervention arm

Interventions

Training for health care professionals on how to identify and manage cases of elder abuse among their patients

Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Only administrative work and no direct patient contact
  • Not participating at the training session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Region Jönköpings län

Eksjö, Sweden

Location

Region Jönköpings Län

Jönköping, Sweden

Location

Region Östergötland

Linköping, Sweden

Location

Region Östergötland

Norrköping, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 34006271BACKGROUND
  • 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.

    PMID: 35508341BACKGROUND

Related Links

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Johanna Simmons, MD, PhD

    Region Östergötland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Non-randomized stepped wedge cluster trial (incomplete design)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 4, 2021

Study Start

September 16, 2021

Primary Completion

November 18, 2024

Study Completion

November 18, 2024

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

There is a plan to make anonymous participant data that underlie results in publications available. However, we are still waiting on final guidelines from the sponsor concerning sharing data and in the unlikely case that the new guidelines prohibit sharing data it will not be shared.

Time Frame
Data will become available alongside publications.
Access Criteria
Will be made available from the researcher upon reasonable request or made available from a public depository.

Locations