Knowledge and Interpersonal Skills to Develop Exemplary Relationships (KINDER): Pilot Study

Dementia Clinical Trial

— KINDER  

Official title:

Knowledge and Interpersonal Skills to Develop Exemplary Relationships (Pilot 2)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05783102
• Other study ID #: STUDY20221333
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 13, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: March 2024
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: May 30, 2024
• Est. primary completion date: March 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Caregiver Burden
• Dementia
• Elder Abuse
• Relation, Family

Intervention

Behavioral:
• Knowledge and Interpersonal Skills to Develop Exemplary Relationships
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.

Locations

Country	Name	City	State
United States	Case Western Reserve University	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resourcefulness	Resourcefulness is measured using the 28-item Caregiver Resourcefulness Scale (a=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 1 week)
Secondary	Caregiving Relationship Strain	Relationship strain will be measured using the 5-item Strain Scale of the Dyadic Relationship Scale (a=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.	Change from baseline to post-intervention (within 1 week)
Secondary	Quality of Caregiving	Quality of caregiving will be measured with the Task Management Strategy Index (TMSI; a=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.	Change from baseline to post-intervention (within 1 week)
Secondary	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; a=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.	Change from baseline to post-intervention (within 1 week)