NCT05783102

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

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

March 13, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 9, 2025

Completed
Last Updated

January 9, 2025

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

March 13, 2023

Results QC Date

September 1, 2024

Last Update Submit

November 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).

Secondary Outcomes (3)

  • Caregiving Relationship Strain

    Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).

  • Quality of Caregiving

    Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).

  • Frequency of Psychological Elder Mistreatment

    Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).

Study Arms (1)

KINDER Intervention

EXPERIMENTAL

KINDER is a 9-week psychoeducational intervention.

Behavioral: Knowledge and Interpersonal Skills to Develop Exemplary Relationships

Interventions

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.

KINDER Intervention

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Does not read and speak English
  • Cannot reliably access a computer and internet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Related Publications (10)

  • 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.

    PMID: 20019303BACKGROUND
  • Burnes 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.

    PMID: 26874186BACKGROUND
  • Conrad 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.

    PMID: 21173437BACKGROUND
  • DeLiema 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.

    PMID: 22697790BACKGROUND
  • Gitlin 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.

    PMID: 11815700BACKGROUND
  • McClendon 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.

    PMID: 24171485BACKGROUND
  • Reamy 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.

    PMID: 21383111BACKGROUND
  • Straus, 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
  • 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.

    PMID: 16764178BACKGROUND
  • Meyer 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.

MeSH Terms

Conditions

DementiaCaregiver Burden

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Results Point of Contact

Title
Kylie Meyer
Organization
Case Western Reserve University

Study Officials

  • Kylie N Meyer, PhD, MSc

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 24, 2023

Study Start

March 13, 2023

Primary Completion

March 16, 2024

Study Completion

March 16, 2024

Last Updated

January 9, 2025

Results First Posted

January 9, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations