Case Western Reserve University
Cleveland, Ohio, 44106, United States
NCT Number: NCT05783102
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44106, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).
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.
Time frame: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).
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.
Time frame: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).
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.
Case Western Reserve University
Other
Knowledge and Interpersonal Skills to Develop Exemplary Relationships (Pilot 2)
Acronym: KINDER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05527405
Alzheimer Disease, Assistive Technology
Atlanta, Georgia, United States
View Trial DetailsNCT06557863
Alzheimer Disease, Behavior
Manhasset, New York, United States
View Trial DetailsNCT06072274
Behavior, Behavioral Symptoms
Taipei, Taiwan
View Trial DetailsNCT05551533
Behavior, Behavioral Symptoms
Singapore
View Trial Details