Responding to Elder Abuse in GERiAtric Care - Dementia

NCT06659822 | Completed

• 3 other identifiers: 2021-05822-0120210151941250 and 981144
• Study Type: observational
• Target: 216
• Locations: 1 country
• Sites: 2

Brief 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. 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:

• 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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  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)

  Participant fill out questionnaire (REAGERA-S20/REAGERA-N) as well as the FAQ at enrollment.

• Expected associations with established outcomes (ZBI)

  Participant fill out questionnaire (REAGERA-S20/REAGERA-N) as well as the ZBI at enrollment

Study Arms (2)

People with dementia

People diagnosed with dementia

Next of kin

Next of kin to people with dementia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Region Östergötland: lead
• Linkoeping University: collaborator
• Jonkoping County Hospital: collaborator
• Jonkoping University: collaborator

Study Sites (2)

Region Jönköpings Län

Jönköping, 55111, Sweden

Location

Region Östergötland

Linköping, 58191, Sweden

Location

Related Publications (1)

• 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.

  PMID: 40855257 DERIVED

Related Links

• Webpage of research program

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 26, 2024
• Study Start: May 15, 2023
• Primary Completion: April 9, 2025
• Study Completion: April 9, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

SE (2)