Trial Outcomes & Findings for Knowledge and Interpersonal Skills to Develop Exemplary Relationships (KINDER): Pilot Study (NCT NCT05783102)
NCT ID: NCT05783102
Last Updated: 2025-01-09
Results Overview
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.
COMPLETED
NA
45 participants
Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).
2025-01-09
Participant Flow
Participant milestones
| Measure |
KINDER Intervention
KINDER is a 9-week psychoeducational intervention.
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.
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|---|---|
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Overall Study
STARTED
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45
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Overall Study
COMPLETED
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42
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
KINDER Intervention
KINDER is a 9-week psychoeducational intervention.
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.
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Overall Study
Lost to Follow-up
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1
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Overall Study
Withdrawal by Subject
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2
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Baseline Characteristics
Two participants had missing data for this variable.
Baseline characteristics by cohort
| Measure |
KINDER Intervention
n=45 Participants
KINDER is a 9-week psychoeducational intervention.
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.
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Race (NIH/OMB)
More than one race
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5 Participants
n=45 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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6 Participants
n=45 Participants
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Age, Continuous
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58.0 years
STANDARD_DEVIATION 14.9 • n=43 Participants • Two participants had missing data for this variable.
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Sex: Female, Male
Female
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39 Participants
n=44 Participants • One participant had missing data for this variable.
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Sex: Female, Male
Male
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5 Participants
n=44 Participants • One participant had missing data for this variable.
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Ethnicity (NIH/OMB)
Hispanic or Latino
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14 Participants
n=45 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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30 Participants
n=45 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=45 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=45 Participants
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Race (NIH/OMB)
Asian
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7 Participants
n=45 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=45 Participants
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Race (NIH/OMB)
Black or African American
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2 Participants
n=45 Participants
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Race (NIH/OMB)
White
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25 Participants
n=45 Participants
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PRIMARY outcome
Timeframe: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).Population: Only participants who completed the Caregiver Resourcefulness Scale without missing data were included in the analysis. This explains why the number of participants analyzed is lower than the overall total number of study participants.
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.
Outcome measures
| Measure |
KINDER Intervention
n=28 Participants
KINDER is a 9-week psychoeducational intervention.
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.
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Resourcefulness
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9.20 score on a scale
Standard Deviation 14.3
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SECONDARY outcome
Timeframe: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).Population: Only participants who completed the Caregiving Relationship Scale without missing data were included in the analysis. This explains why the number of participants analyzed is lower than the overall total number of study participants.
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.
Outcome measures
| Measure |
KINDER Intervention
n=34 Participants
KINDER is a 9-week psychoeducational intervention.
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.
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Caregiving Relationship Strain
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-2.6 score on a scale
Standard Deviation 3.3
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SECONDARY outcome
Timeframe: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).Population: Only participants who completed the Quality of Caregiving Scale without missing data were included in the analysis. This explains why the number of participants analyzed is lower than the overall total number of study participants.
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.
Outcome measures
| Measure |
KINDER Intervention
n=26 Participants
KINDER is a 9-week psychoeducational intervention.
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.
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Quality of Caregiving
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6.0 score on a scale
Standard Deviation 13.7
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SECONDARY outcome
Timeframe: Change from baseline to post-intervention (within 2 weeks after the 9 weeks intervention).Population: Only participants who completed the Modified Conflict Tactics Scale-2 without missing data were included in the analysis. This explains why the number of participants analyzed is lower than the overall total number of study participants.
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.
Outcome measures
| Measure |
KINDER Intervention
n=31 Participants
KINDER is a 9-week psychoeducational intervention.
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.
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Frequency of Psychological Elder Mistreatment
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-1.6 score on a scale
Standard Deviation 2.9
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Adverse Events
KINDER Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place