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Clinical Trials/NCT05783102
NCT05783102CompletedNot Applicable

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

Case Western Reserve University2 sites in 1 country45 target enrollmentStarted: March 13, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
45
Locations
2
Primary Endpoint
Resourcefulness

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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).)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kylie Meyer

Assistant Professor

Case Western Reserve University

Study Sites (2)

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