Elder AbuseREAGERANCT06659822
Responding to Elder Abuse in GERiAtric Care - Dementia
An observational study of Elder Abuse and Dementia, run by Region Östergötland at 2 sites in Sweden.
Trial summary
Abuse of older people is common and people with dementia are especially susceptible to abuse. Older people may be subjected to physical, psychological, sexual, financial abuse or neglect by relatives as well as health and social care professionals or other people in a relationship involving an expectation of trust. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Elder Abuse, Dementia
- How many people
- 216 participants
- Where
- 2 sitesSweden
- Study dates
- 15 May 2023to 9 Apr 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: - Patient and next of kin that come in contact with memory clinics or in muncipality care provided to people with dementia in the participating study locations.
Who may be able to join
- Patient: Being diagnosed with dementia of mild to moderate degree (assessed by the Global Deterioration Scale (GDS) level 4 or 5)
- Next of kin: Being the next of kin to a person with dementia, GDS = 4-7
Who cannot join
- Both patient and next of kin: Severe psychiatric disorder, not being able to answer the questionnaires or participate in an interview, e.g. due to insufficient proficiency in Swedish, aphasia, hearing loss or similar.
- People with dementia: experiencing symptoms that may be exacerbated by study participation or make results less reliable (e.g. paranoia).
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Region Jönköpings Län
Jönköping, 55111
Region Östergötland
Linköping, 58191
About this study
Official title: Responding to Elder Abuse in GERiAtric Care (REAGERA) - Dementia Validation of Screening Instruments to Detect Abuse of Persons With Dementia
Abuse of older people is common and people with dementia are especially susceptible to abuse. Older people may be subjected to physical, psychological, sexual, financial abuse or neglect by relatives as well as health and social care professionals or other people in a relationship involving an expectation of trust. Reporting experiences of abuse is associated with poor health outcomes. Still, abusive experiences are often unknown to professionals.
This study protocol describes the development and procedure to test the validity of two new screening instruments (REAGERA-S20 and REAGERA-N) to detect abuse of people with dementia. The aims of the study are:
Read more
- To assess the validity of two new self-administered screening tools to detect abusive experiences among people with dementia: the REAGERA-S20 directed at people with dementia and the REAGERA-N directed at the next of kin.
- To translate and validate a Swedish version of the Risk of Elder Abuse and Mistreatment Instrument (REAMI) that can be used by professional caregivers to estimate risk of maltreatment and abuse of people with dementia.
- To explore experiences of abuse among people with dementia and their next of kin.
Method People with mild to moderate dementia (n=80) and their next of kin (n=80) are recruited at health and social care facilities providing care to people with dementia. In cases of severe dementia or when the person with dementia is excluded for other reasons, only next of kin is included.
The following steps are used in the data collection
- Participants fill out the REAGERA-S20 or REAGERA-N individually.
- Participants are interviewed individually by two different researchers about their abusive experiences. If a participant talks about abusive experiences, a qualitative in-depth interview about those experiences is conducted.
- A preliminary classification of the participants as abused or not abused, based only on information provided in the individual interview is made.
- Information provided in the two individual interviews are compared by the researchers. If needed, and with permission obtained individually from the participants, a joint concluding interview is conducted to clarify inconsistencies.
- A final classification of participants experiences of abuse is made based on the information provided in both interviews.
The validity of the REAGERA-S20/REAGERA-N will be calculated using the following classification of participants made in the interviews as gold standard (aim 1):
For the person with dementia
- Reporting or not reporting abusive experiences during the past 12 months.
- Reporting or not reporting abusive experience earlier in life, i.e. more than 12 months ago.
For the next of kin
- Reporting or not reporting own exposure to abuse by the person with dementia during the past 12 months.
- Reporting or not reporting own perpetration of abuse towards the person with dementia during the past 12 months.
- Reporting or not reporting that the person with dementia has been exposed to abuse by another person during the past 12 months.
- Reporting or not reporting that the person with dementia has been exposed to abuse earlier in life, i.e. more than 12 months ago.
After completion of data collection, the REAMI is filled out by a health or social care professional with knowledge about the participant with dementia. Validity of the instrument will be calculated using the information provided in the interview as the gold standard (aim 2).
All interviews are recorded and transcribed verbatim. Analyses of the qualitative interviews will be made to explore experiences of abuse among participants (aim 3).
- Conditions
- Elder Abuse, Dementia
- Keywords
- Validation of screening instruments to detect elder abuse
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with dementia | People diagnosed with dementia | |
| Next of kin | Next of kin to people with dementia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of REAGERA-S20 and REAGERA-N
Sensitivity, specificity, positive and negative likelihood ratio as well as positive and negative predictive value of REAGERA-S20 and REAGERA-N will be calculated. The final classification made after interviewing both the person with dementia and the next of kin will be used as the gold standard.
Measured: Participant fill out questionnaire (REAGERA-S20/REAGERA-N) at enrollment Semi-structured interview used as gold standard is conducted immediately afterwards.
Predictive value of the introductory screening questions in part one
Test the predictive value of the introductory screening questions in part one of each instrument to identify abusive experiences as identified in part two of the instruments as well as in the final classification made after both individual and joint interview.
Measured: Participant fill out questionnaire (REAGERA-S20/REAGERA-N) at enrollment. Semi-structured interview used as gold standard is conducted immediately afterwards.
Validity of the REAMI
Health and social care professionals fill out the REAMI questionnaire assessing risk of abuse. Sensitivity, specificity, positive and negative likelihood ratio as well as positive and negative predictive value will be calculated for REAMI concerning its ability to detect abusive experiences. The interview conducted with participants will be used as the gold standard for calculations.
Measured: Semi-structured interview used as gold standard is conducted at enrollment. Health and social care professionals fill out the REAMI at some point between patient enrollment and end of study, but usually within a few weeks of enrollment.
Secondary outcomes (3)
Validity of REAGERA-S20 and REAGERA-N using individual interview as gold standard
Sensitivity, specificity, positive and negative likelihood ratio as well as positive and negative predictive value for REAGERA-S20/REAGERA-N using only information given in the individual interview with the person with dementia or the next of kind respectively as the gold standard.
Measured: Participant fill out questionnaire (REAGERA-S20/REAGERA-N) at enrollment. Semi-structured interview used as gold standard is conducted immediately afterwards.
Expected associations with established outcomes (FAQ)
Associations between reporting abuse in REAGERA-S20/REAGERA-N and high score on the Functional Activities Questionnaire (FAQ) will be calculated. The FAQ consists of ten items and each item can be scored from 0 (no dependence) to 3 (totally dependent). A sum score (0-30) will be calculated and a higher score indicates a greater dependence on others for activities in daily living.
Measured: Participant fill out questionnaire (REAGERA-S20/REAGERA-N) as well as the FAQ at enrollment.
Expected associations with established outcomes (ZBI)
Associations between reporting abuse in REAGERA-S20/REAGERA-N and high score on the Zarit Burden Interview (ZBI). The 12 items ZBI is used and each item is answered on a scale from 0 (never) to 4 (almost always). A sum score will be created for all items (range 0-48) and a higher sum score indicate a greater care giver burden.
Measured: Participant fill out questionnaire (REAGERA-S20/REAGERA-N) as well as the ZBI at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start15 May 2023
- Primary completion9 Apr 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elder AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University, Jonkoping County Hospital, Jonkoping University
- Responsible party
- Principal investigator, Johanna Simmons, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659822
- Sponsor's protocol ID
- 2021-05822-01
- Other IDs
- 20210151, 941250 and 981144
- Acronym
- REAGERA
- Status last verified
- Jan 2025
- First submitted
- 22 Oct 2024
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous quantitative data will be made available from the researcher upon reasonable request.
Publications
Simmons J, Floberg E, Casselgren C, Westerlind B, Sandberg J, Swahnberg K, Nagga K, Ludvigsson M, Johansson L. REAGERA-dementia: study protocol for the validation of screening instruments to detect abuse of people with dementia. BMC Geriatr. 2025 Aug 25;25(1):660. doi: 10.1186/s12877-025-06291-z.
PubMed 40855257
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responding to Elder Abuse in GERiAtric Care (REAGERA) - Dementia Validation of Screening Instruments to Detect Abuse of Persons With Dementia
- ClinicalTrials.gov ID
- NCT06659822
- Acronym / sponsor ID
- REAGERA / 2021-05822-01
- Conditions
- Elder Abuse, Dementia
- Keywords
- Validation of screening instruments to detect elder abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Collaborators
- Linkoeping University, Jonkoping County Hospital, Jonkoping University
- Study start
- 15 May 2023 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Abuse of older people is common and people with dementia are especially susceptible to abuse. Older people may be subjected to physical, psychological, sexual, financial abuse or neglect by relatives as well as health and social care professionals or other people in a relationship involving an expectation of trust. Reporting experiences of abuse is associated with poor health outcomes. Still, abusive experiences are often unknown to professionals.
This study protocol describes the development and procedure to test the validity of two new screening instruments (REAGERA-S20 and REAGERA-N) to detect abuse of people with dementia. The aims of the study are:
- To assess the validity of two new self-administered screening tools to detect abusive experiences among people with dementia: the REAGERA-S20 directed at people with dementia and the REAGERA-N directed at the next of kin.
- To translate and validate a Swedish version of the Risk of Elder Abuse and Mistreatment Instrument (REAMI) that can be used by professional caregivers to estimate risk of maltreatment and abuse of people with dementia.
- To explore experiences of abuse among people with dementia and their next of kin.
Method People with mild to moderate dementia (n=80) and their next of kin (n=80) are recruited at health and social care facilities providing care to people with dementia. In cases of severe dementia or when the person with dementia is excluded for other reasons, only next of kin is included.
The following steps are used in the data collection
- Participants fill out the REAGERA-S20 or REAGERA-N individually.
- Participants are interviewed individually by two different researchers about their abusive experiences. If a participant talks about abusive experiences, a qualitative in-depth interview about those experiences is conducted.
- A preliminary classification of the participants as abused or not abused, based only on information provided in the individual interview is made.
- Information provided in the two individual interviews are compared by the researchers. If needed, and with permission obtained individually from the participants, a joint concluding interview is conducted to clarify inconsistencies.
- A final classification of participants experiences of abuse is made based on the information provided in both interviews.
The validity of the REAGERA-S20/REAGERA-N will be calculated using the following classification of participants made in the interviews as gold standard (aim 1):
For the person with dementia
- Reporting or not reporting abusive experiences during the past 12 months.
- Reporting or not reporting abusive experience earlier in life, i.e. more than 12 months ago.
For the next of kin
- Reporting or not reporting own exposure to abuse by the person with dementia during the past 12 months.
- Reporting or not reporting own perpetration of abuse towards the person with dementia during the past 12 months.
- Reporting or not reporting that the person with dementia has been exposed to abuse by another person during the past 12 months.
- Reporting or not reporting that the person with dementia has been exposed to abuse earlier in life, i.e. more than 12 months ago.
After completion of data collection, the REAMI is filled out by a health or social care professional with knowledge about the participant with dementia. Validity of the instrument will be calculated using the information provided in the interview as the gold standard (aim 2).
All interviews are recorded and transcribed verbatim. Analyses of the qualitative interviews will be made to explore experiences of abuse among participants (aim 3).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with dementia | – | –People diagnosed with dementia |
| Next of kin | – | –Next of kin to people with dementia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- - Patient and next of kin that come in contact with memory clinics or in muncipality care provided to people with dementia in the participating study locations.
Key inclusion criteria (2 listed)
- Patient: Being diagnosed with dementia of mild to moderate degree (assessed by the Global Deterioration Scale (GDS) level 4 or 5)
- Next of kin: Being the next of kin to a person with dementia, GDS = 4-7
Key exclusion criteria (2 listed)
- Both patient and next of kin: Severe psychiatric disorder, not being able to answer the questionnaires or participate in an interview, e.g. due to insufficient proficiency in Swedish, aphasia, hearing loss or similar.
- People with dementia: experiencing symptoms that may be exacerbated by study participation or make results less reliable (e.g. paranoia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validity of REAGERA-S20 and REAGERA-N
Time frame: Participant fill out questionnaire (REAGERA-S20/REAGERA-N) at enrollment Semi-structured interview used as gold standard is conducted immediately afterwards.
Sensitivity, specificity, positive and negative likelihood ratio as well as positive and negative predictive value of REAGERA-S20 and REAGERA-N will be calculated. The final classification made after interviewing both the person with dementia and the next of kin will be used as the gold standard.
Predictive value of the introductory screening questions in part one
Time frame: Participant fill out questionnaire (REAGERA-S20/REAGERA-N) at enrollment. Semi-structured interview used as gold standard is conducted immediately afterwards.
Test the predictive value of the introductory screening questions in part one of each instrument to identify abusive experiences as identified in part two of the instruments as well as in the final classification made after both individual and joint interview.
Validity of the REAMI
Time frame: Semi-structured interview used as gold standard is conducted at enrollment. Health and social care professionals fill out the REAMI at some point between patient enrollment and end of study, but usually within a few weeks of enrollment.
Health and social care professionals fill out the REAMI questionnaire assessing risk of abuse. Sensitivity, specificity, positive and negative likelihood ratio as well as positive and negative predictive value will be calculated for REAMI concerning its ability to detect abusive experiences. The interview conducted with participants will be used as the gold standard for calculations.
3 secondary outcomes
Validity of REAGERA-S20 and REAGERA-N using individual interview as gold standard
Time frame: Participant fill out questionnaire (REAGERA-S20/REAGERA-N) at enrollment. Semi-structured interview used as gold standard is conducted immediately afterwards.
Expected associations with established outcomes (FAQ)
Time frame: Participant fill out questionnaire (REAGERA-S20/REAGERA-N) as well as the FAQ at enrollment.
Expected associations with established outcomes (ZBI)
Time frame: Participant fill out questionnaire (REAGERA-S20/REAGERA-N) as well as the ZBI at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Derived from this study: PubMed 40855257Simmons J, Floberg E, Casselgren C, Westerlind B, Sandberg J, Swahnberg K, Nagga K, Ludvigsson M, Johansson L. REAGERA-dementia: study protocol for the validation of screening instruments to detect abuse of people with dementia. BMC Geriatr. 2025 Aug 25;25(1):660. doi: 10.1186/s12877-025-06291-z.
- Webpage of research programLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymous quantitative data will be made available from the researcher upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elder Abuse and Dementia, run by Region Östergötland at 2 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 2 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 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Validity of REAGERA-S20 and REAGERA-N (time frame: Participant fill out questionnaire (REAGERA-S20/REAGERA-N) at enrollment Semi-structured interview used as gold standard is conducted immediately afterwards.). The study lists 3 primary outcomes in all. 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 NCT06659822, which also lists 1 linked publication.
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 23 Apr 2025.