DementiaKINDERNCT05783102
Knowledge and Interpersonal Skills to Develop Exemplary Relationships (KINDER): Pilot Study
A study testing Knowledge and Interpersonal Skills to Develop Exemplary Relationships in people with Dementia and Caregiver Burden, run by Case Western Reserve University at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility and acceptability of delivering the KINDER intervention to family caregivers to persons living with dementia. Further, the investigators will examine the preliminary efficacy of the KINDER intervention at improving caregiver resourcefulness, relationship… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Caregiver Burden, Relation, Family
- What is being tested?
- Knowledge and Interpersonal Skills to Develop Exemplary Relationships
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to 16 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is age 18+
- Provides care to a family member or friend living with Alzheimer's Disease or a related dementia.
- Helps with at least 1 activity of daily living (e.g., bathing) or 2 instrumental activities of daily living (e.g., shopping)
- Provides at least 8 hours of assistance to the care recipient per week
- Does not intend to place the care recipient in a skilled nursing facility within 3 months of consenting into the study
Who cannot join
- Does not read and speak English
- Cannot reliably access a computer and internet
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
About this study
Official title: Knowledge and Interpersonal Skills to Develop Exemplary Relationships (Pilot 2)
The purpose of this study is to determine the feasibility and acceptability of delivering the KINDER intervention to family caregivers to persons living with dementia. Further, the investigators will examine the preliminary efficacy of the KINDER intervention at improving caregiver resourcefulness, relationship quality, and quality of care, including reduction of potential verbal-type elder mistreatment.
During this study, participants will be asked to complete two (2) 30- to 45-minute surveys asking about their demographic information, caregiving situations, and relationship with the care recipient. The first survey will be sent within two weeks of beginning the KINDER intervention, the second will be sent within one week after participants complete the KINDER intervention so we can compare outcomes.
- Conditions
- Dementia, Caregiver Burden, Relation, Family, Elder Abuse
- Being tested
- Knowledge and Interpersonal Skills to Develop Exemplary Relationships
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge and Interpersonal Skills to Develop Exemplary RelationshipsBehavioural
During this 9-week psychoeducational intervention, participants will complete eight weekly, self-paced lessons that include a short video vignette, written text, a reading quiz, and a reflection exercise. Topics include understanding a dementia diagnosis, communicating with a person you care for about challenging topics, finding a balance between safety concerns and independence, and more. Each lesson takes an estimated 1 hour to complete. Independent KINDER lessons can be completed using a printed or digital copy of the KINDER Workbook. In addition, participants will be asked to participate in three, 1.5-hour group discussion sessions with other caregivers and a facilitator. These sessions will take place over Zoom video conference.
| Study group | Role | What they receive |
|---|---|---|
| KINDER Intervention | Experimental | KINDER is a 9-week psychoeducational intervention. Receives: Behavioral: Knowledge and Interpersonal Skills to Develop Exemplary Relationships |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resourcefulness
Resourcefulness is measured using the 28-item Caregiver Resourcefulness Scale (α=0.85; Zauszniewski, 2006). This scale has two factors: one focused on help-seeking and another on self-help. Caregivers are asked the frequency at which they use different strategies to manage challenges, and may respond: Not at all like me (0), Pretty much not like me (1), A little bit not like me (2), A little bit like me (3), Pretty much like much like me (4), or Very much like me (5). Items are added together to create a total score. Scores range from 0 to 140, where higher scores indicate higher levels of resourcefulness. The outcome measure will use the average change score from baseline scores until the post-intervention survey.
Measured: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).
Secondary outcomes (3)
Caregiving Relationship Strain
Relationship strain will be measured using the 5-item Strain Scale of the Dyadic Relationship Scale (α=0.69; Reamy et al., 2011). Respondents are asked to indicate agreement with statements such as, "The patient made too many requests," and may indicate Strongly Disagree, Disagree, Agree, or Strongly Agree. The scale has a range of scores from 4 to 20, where higher scores indicate greater levels of relationship strain. The outcome measure will use the average change score from baseline scores until the post-intervention survey.
Measured: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).
Quality of Caregiving
Quality of caregiving will be measured with the Task Management Strategy Index (TMSI; α=0.74 to 0.81; McClendon \& Smyth, 2013). The 19-item TMSI was developed to assess caregivers' ability to manage their family member's functional disabilities. (Gitlin et al., 2002) Caregivers are asked how often they engage in strategies that support quality care. Caregivers indicate Never, Rarely, Sometimes, Often, or Always. Scores range from 19 to 95. Higher scores indicate higher quality of caregiving. The outcome measure will use the average change score from baseline scores until the post-intervention survey.
Measured: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).
Frequency of Psychological Elder Mistreatment
The investigators will use a modified version of the Conflict Tactics Scale 2 to measure psychological elder mistreatment (MCTS 2; α=0.79; Straus et al., 2016). Items include behaviors such as insulting, swearing at, or yelling at a partner. To measure a range of psychological elder mistreatment behaviors, we will add three items: ignoring the care recipient (DeLiema et al., 2012), threatening to isolate the care recipient (Acierno et al., 2010), and talking about the care recipient as if they are not there (Conrad et al., 2011). To describe the severity of mistreatment (Burnes et al., 2017), participants will be asked to describe the frequency of each behavior, such that response options will include: None, Once, Twice, 3 to 5 times, 6 to 10 times, and More than 10 times. Scores range from 0 to 50. Higher scores indicate higher quality of caregiving. The outcome measure will use the average change score from baseline scores until the post-intervention survey.
Measured: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start13 Mar 2023
- Primary completion16 Mar 2024
- Study completion16 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Principal investigator, Kylie Meyer, Case Western Reserve University
- Investigators
- Kylie N Meyer, PhD, MSc, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783102
- Sponsor's protocol ID
- STUDY20221333
- Acronym
- KINDER
- Status last verified
- Nov 2024
- First submitted
- 13 Mar 2023
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Acierno R, Hernandez MA, Amstadter AB, Resnick HS, Steve K, Muzzy W, Kilpatrick DG. Prevalence and correlates of emotional, physical, sexual, and financial abuse and potential neglect in the United States: the National Elder Mistreatment Study. Am J Public Health. 2010 Feb;100(2):292-7. doi: 10.2105/AJPH.2009.163089. Epub 2009 Dec 17.
PubMed 20019303Burnes D, Pillemer K, Lachs MS. Elder Abuse Severity: A Critical but Understudied Dimension of Victimization for Clinicians and Researchers. Gerontologist. 2017 Aug 1;57(4):745-756. doi: 10.1093/geront/gnv688.
PubMed 26874186Conrad KJ, Iris M, Ridings JW, Langley K, Anetzberger GJ. Self-report measure of psychological abuse of older adults. Gerontologist. 2011 Jun;51(3):354-66. doi: 10.1093/geront/gnq103. Epub 2010 Dec 20.
PubMed 21173437DeLiema M, Gassoumis ZD, Homeier DC, Wilber KH. Determining prevalence and correlates of elder abuse using promotores: low-income immigrant Latinos report high rates of abuse and neglect. J Am Geriatr Soc. 2012 Jul;60(7):1333-9. doi: 10.1111/j.1532-5415.2012.04025.x. Epub 2012 Jun 14.
PubMed 22697790Gitlin LN, Winter L, Dennis MP, Corcoran M, Schinfeld S, Hauck WW. Strategies used by families to simplify tasks for individuals with Alzheimer's disease and related disorders: psychometric analysis of the Task Management Strategy Index (TMSI). Gerontologist. 2002 Feb;42(1):61-9. doi: 10.1093/geront/42.1.61.
PubMed 11815700McClendon MJ, Smyth KA. Quality of informal care for persons with dementia: dimensions and correlates. Aging Ment Health. 2013;17(8):1003-15. doi: 10.1080/13607863.2013.805400. Epub 2013 Jun 11.
PubMed 24171485Reamy AM, Kim K, Zarit SH, Whitlatch CJ. Understanding discrepancy in perceptions of values: individuals with mild to moderate dementia and their family caregivers. Gerontologist. 2011 Aug;51(4):473-83. doi: 10.1093/geront/gnr010. Epub 2011 Mar 7.
PubMed 21383111Straus, MA, Hamby, SL, Boney-McCoy, SUE, & Sugarman, DB. The Revised Conflict Tactics Scales (CTS2). Journal of Family Issues. 2016; 17(3): 283-316. doi: 10.1177/01925139601700300.
Zauszniewski JA, Lai CY, Tithiphontumrong S. Development and testing of the Resourcefulness Scale for Older Adults. J Nurs Meas. 2006 Spring-Summer;14(1):57-68. doi: 10.1891/jnum.14.1.57.
PubMed 16764178Meyer K, Wei W, Yonashiro-Cho J, Mage S, Kim S, Irani E, Burant C, Gassoumis Z, Lamb EG, Zauszniewski JA, Benton D. Acceptability of an Intervention to Prevent Older Adult Mistreatment Among Family Caregivers to Persons With Dementia: Multimethod Pilot Study. JMIR Form Res. 2025 Jul 30;9:e73778. doi: 10.2196/73778.
PubMed 40737062
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Interpersonal Skills to Develop Exemplary Relationships (Pilot 2)
- ClinicalTrials.gov ID
- NCT05783102
- Acronym / sponsor ID
- KINDER / STUDY20221333
- Conditions
- Dementia, Caregiver Burden, Relation, Family, Elder Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 16 Mar 2024 (actual)
- Study completion
- 16 Mar 2024 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the feasibility and acceptability of delivering the KINDER intervention to family caregivers to persons living with dementia. Further, the investigators will examine the preliminary efficacy of the KINDER intervention at improving caregiver resourcefulness, relationship quality, and quality of care, including reduction of potential verbal-type elder mistreatment.
During this study, participants will be asked to complete two (2) 30- to 45-minute surveys asking about their demographic information, caregiving situations, and relationship with the care recipient. The first survey will be sent within two weeks of beginning the KINDER intervention, the second will be sent within one week after participants complete the KINDER intervention so we can compare outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KINDER Intervention | Experimental | Behavioral: Knowledge and Interpersonal Skills to Develop Exemplary RelationshipsKINDER is a 9-week psychoeducational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is age 18+
- Provides care to a family member or friend living with Alzheimer's Disease or a related dementia.
- Helps with at least 1 activity of daily living (e.g., bathing) or 2 instrumental activities of daily living (e.g., shopping)
- Provides at least 8 hours of assistance to the care recipient per week
- Does not intend to place the care recipient in a skilled nursing facility within 3 months of consenting into the study
Key exclusion criteria (2 listed)
- Does not read and speak English
- Cannot reliably access a computer and internet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knowledge and Interpersonal Skills to Develop Exemplary RelationshipsDuring this 9-week psychoeducational intervention, participants will complete eight weekly, self-paced lessons that include a short video vignette, written text, a reading quiz, and a reflection exercise. Topics include understanding a dementia diagnosis, communicating with a person you care for about challenging topics, finding a balance between safety concerns and independence, and more. Each lesson takes an estimated 1 hour to complete. Independent KINDER lessons can be completed using a printed or digital copy of the KINDER Workbook. In addition, participants will be asked to participate in three, 1.5-hour group discussion sessions with other caregivers and a facilitator. These sessions will take place over Zoom video conference. | Behavioural | KINDER Intervention |
Primary outcome
Resourcefulness
Time frame: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).
Resourcefulness is measured using the 28-item Caregiver Resourcefulness Scale (α=0.85; Zauszniewski, 2006). This scale has two factors: one focused on help-seeking and another on self-help. Caregivers are asked the frequency at which they use different strategies to manage challenges, and may respond: Not at all like me (0), Pretty much not like me (1), A little bit not like me (2), A little bit like me (3), Pretty much like much like me (4), or Very much like me (5). Items are added together to create a total score. Scores range from 0 to 140, where higher scores indicate higher levels of resourcefulness. The outcome measure will use the average change score from baseline scores until the post-intervention survey.
3 secondary outcomes
Caregiving Relationship Strain
Time frame: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).
Quality of Caregiving
Time frame: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).
Frequency of Psychological Elder Mistreatment
Time frame: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20019303Acierno R, Hernandez MA, Amstadter AB, Resnick HS, Steve K, Muzzy W, Kilpatrick DG. Prevalence and correlates of emotional, physical, sexual, and financial abuse and potential neglect in the United States: the National Elder Mistreatment Study. Am J Public Health. 2010 Feb;100(2):292-7. doi: 10.2105/AJPH.2009.163089. Epub 2009 Dec 17.
- Background: PubMed 26874186Burnes D, Pillemer K, Lachs MS. Elder Abuse Severity: A Critical but Understudied Dimension of Victimization for Clinicians and Researchers. Gerontologist. 2017 Aug 1;57(4):745-756. doi: 10.1093/geront/gnv688.
- Background: PubMed 21173437Conrad KJ, Iris M, Ridings JW, Langley K, Anetzberger GJ. Self-report measure of psychological abuse of older adults. Gerontologist. 2011 Jun;51(3):354-66. doi: 10.1093/geront/gnq103. Epub 2010 Dec 20.
- Background: PubMed 22697790DeLiema M, Gassoumis ZD, Homeier DC, Wilber KH. Determining prevalence and correlates of elder abuse using promotores: low-income immigrant Latinos report high rates of abuse and neglect. J Am Geriatr Soc. 2012 Jul;60(7):1333-9. doi: 10.1111/j.1532-5415.2012.04025.x. Epub 2012 Jun 14.
- Background: PubMed 11815700Gitlin LN, Winter L, Dennis MP, Corcoran M, Schinfeld S, Hauck WW. Strategies used by families to simplify tasks for individuals with Alzheimer's disease and related disorders: psychometric analysis of the Task Management Strategy Index (TMSI). Gerontologist. 2002 Feb;42(1):61-9. doi: 10.1093/geront/42.1.61.
- Background: PubMed 24171485McClendon MJ, Smyth KA. Quality of informal care for persons with dementia: dimensions and correlates. Aging Ment Health. 2013;17(8):1003-15. doi: 10.1080/13607863.2013.805400. Epub 2013 Jun 11.
- Background: PubMed 21383111Reamy AM, Kim K, Zarit SH, Whitlatch CJ. Understanding discrepancy in perceptions of values: individuals with mild to moderate dementia and their family caregivers. Gerontologist. 2011 Aug;51(4):473-83. doi: 10.1093/geront/gnr010. Epub 2011 Mar 7.
- BackgroundStraus, MA, Hamby, SL, Boney-McCoy, SUE, & Sugarman, DB. The Revised Conflict Tactics Scales (CTS2). Journal of Family Issues. 2016; 17(3): 283-316. doi: 10.1177/01925139601700300.
- Background: PubMed 16764178Zauszniewski JA, Lai CY, Tithiphontumrong S. Development and testing of the Resourcefulness Scale for Older Adults. J Nurs Meas. 2006 Spring-Summer;14(1):57-68. doi: 10.1891/jnum.14.1.57.
- Derived from this study: PubMed 40737062Meyer K, Wei W, Yonashiro-Cho J, Mage S, Kim S, Irani E, Burant C, Gassoumis Z, Lamb EG, Zauszniewski JA, Benton D. Acceptability of an Intervention to Prevent Older Adult Mistreatment Among Family Caregivers to Persons With Dementia: Multimethod Pilot Study. JMIR Form Res. 2025 Jul 30;9:e73778. doi: 10.2196/73778.
- Individual participant dataSharing planned: No
Related trials for Dementia
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
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.
Kylie N Meyer, PhD, MSc principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knowledge and Interpersonal Skills to Develop Exemplary Relationships in people with Dementia and Caregiver Burden, run by Case Western Reserve University at 1 site in United States.
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 5 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 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Resourcefulness (time frame: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).). 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 NCT05783102, which also lists 10 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 9 Jan 2025.