Caregiver Burden, Dementia, Elder Abuse, Relation, Family
Conditions
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.
Interventions
BEHAVIORALKnowledge 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.
Sponsors
University of Southern California
Case Western Reserve University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resourcefulness | 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
| Measure | Time frame | Description |
|---|---|---|
| Caregiving Relationship Strain | 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. |
| Quality of Caregiving | 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. |
| Frequency of Psychological Elder Mistreatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | KINDER Intervention |
|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KINDER Intervention | Resourcefulness | 9.20 score on a scale | Standard Deviation 14.3 |
Secondary
Caregiving Relationship Strain
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).
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KINDER Intervention | Caregiving Relationship Strain | -2.6 score on a scale | Standard Deviation 3.3 |
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; 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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KINDER Intervention | Frequency of Psychological Elder Mistreatment | -1.6 score on a scale | Standard Deviation 2.9 |
Secondary
Quality of Caregiving
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).
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KINDER Intervention | Quality of Caregiving | 6.0 score on a scale | Standard Deviation 13.7 |