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HealthyREAGERA eduNCT05065281

Responding to Elder Abuse in GERiAtric Care: Educational Intervention

A study testing Education in people with Healthy, run by Region Östergötland at 4 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Healthy
What is being tested?
Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
554 participants
Where
4 sitesSweden
Study dates
16 Sep 2021to 18 Nov 2024
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Sweden4 sites

  • Region Jönköpings län

    Eksjö

  • Region Jönköpings Län

    Jönköping

  • Region Östergötland

    Linköping

  • Region Östergötland

    Norrköping

Other trials in Sweden

About this study

Official title: 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

Read the detailed description

Please refer to the uploaded study protocol for a detailed description of the study.

Conditions
Healthy
Being tested
Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EducationOther

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

Study groups in NCT05065281
Study groupRoleWhat they receive
EducationExperimentalParticipants that have undergone the educational intervention
Receives: Other: Education
WaitlistNo interventionParticipants still waiting to cross over to intervention arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline, 6 month follow up, 12 month follow up

Secondary outcomes (5)

  1. 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

    1. Self-reported perceived lack of awareness of elder abuse as a barrier toward identifying victims.
    2. Self reported sense of responsibility for asking questions about abuse (own responsibility, professions' responsibility, health care services responsibility)

    Measured: Baseline, Immediate post-intervention (number 2), 6 month follow up, 12 month follow up

  2. Change between baseline and follow up concerning level of awareness of abuse in contact with patients, as reported in the questionnaire REAGERA-P

    Patient case ("Vignette") with indicators of abuse and participants self-report if they think they would have asked the patient questions about abuse

    Measured: Baseline, 6 or 12 month follow up (different for different clusters)

  3. Change between baseline and follow up concerning perceived ability to ask questions about abuse, as reported in REAGERA-P

    1. Self-reported self-efficacy for asking questions about elder abuse.
    2. Self-reported cause for concern that asking questions will a) lead to a negative reaction from the patient b) negatively impact the patient-provider relationship

    Measured: Baseline, Immediate post-intervention, 6 month follow up, 12 month follow up

  4. Change between baseline and follow up concerning perceived preparedness to manage cases of elder abuse, as reported in REAGERA-P

    1. Self-reported self-efficacy for managing cases of elder abuse.
    2. Self-reported cause for concern of not being able to offer the patient a good follow up.
    3. Self-reported collegial support, i.e., knowing which colleague to ask for help if needed when managing cases of elder abuse.
    4. Self-reported knowledge about proper documentation routines
    5. Self-reported knowledge about judicial concerns

    Measured: Baseline, Immediate post-intervention (number 1and 2), 6 months follow up, 12 months follow up

  5. Change between baseline and follow up concerning preparedness at the clinic to care for older adults subjected to abuse, as reported in REAGERA-P

    Self-reported evaluation of:

    1. Routines for managing cases of elder abuse at the clinic
    2. Preparedness at the clinic and in society to care for victims of elder abuse.

    Measured: Baseline, 6 months follow up, 12 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2021
  2. Study start16 Sep 2021
  3. Primary completion18 Nov 2024
  4. Study completion18 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Sequential
Model description
Non-randomized stepped wedge cluster trial (incomplete design)
Masking
None (open label)
Enrolment
554 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05065281
Sponsor's protocol ID
RÖ-786
Acronym
REAGERA edu
Status last verified
Dec 2024
First submitted
15 Sep 2021
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 34006271

  • 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.

    PubMed 35508341

  • Simmons J, Ludvigsson M. Domestic violence among healthcare professionals in Sweden - Prevalence, associations with asking older patients about abuse and reactions to participating in training on abuse of older people. BMC Health Serv Res. 2026 Aug 22;26(1):1177. doi: 10.1186/s12913-026-15440-y.

    PubMed 42642732

Questions about this trial

What is this clinical trial studying?

A study testing Education in people with Healthy, run by Region Östergötland at 4 sites in Sweden.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Sweden. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05065281, which also lists 3 linked publications.

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 18 Dec 2024.

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REAGERA edu Clinical Trial NCT05065281 | AzTrials