Learning Skills Together Family Caregiver Complex Intervention

Study Overview
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Brief Summary
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Learning Skills Together (LST) is a 6-week psychoeducational intervention focused on complex care (nursing) tasks completed by family caregivers to persons living with Alzheimer's Disease and related dementias. This study aims to test the efficacy of LST at reducing caregiver depression and negative appraisal of behavioral symptoms of dementia by building caregiver self-efficacy. To do this, eligible participants will be randomized into an intervention group (LST) or a control group condition focused on healthy living for family caregivers. Participants will be asked to complete surveys before and after participating in the intervention or the control condition to determine whether change in hypothesized outcomes can be attributed to the intervention condition.

Official Title
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Learning Skills Together: A Randomized Controlled Trial of a Complex Care Skills Intervention to Improve AD/ADRD Caregiver Self-Efficacy

Conditions
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Dementia, Alzheimer Disease, Caregiver Burden, Self Efficacy

Intervention / Treatment
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* Behavioral: Learning Skills Together Intervention
* Behavioral: Caregiver Healthy Living Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is aged 18 years or older Be a family member, including families of choice, to an individual living with Alzheimer's disease or a related dementia who has received a diagnosis from a physician Provide assistance with at least two instrumental activities of daily living or one activity of daily living Report a Global Deterioration Scale (GDS) rating for care recipients between 4 to 6 Commit to attending at least 5 of the 6 discussion sessions Has reliable access to the internet and email and be able to attend synchronous sessions using the Zoom videoconferencing platform Exclusion Criteria: Unable to read and speak English Participated in Learning Skills Together in the past Plans to place the care recipient in a skilled nursing facility within the next 9 months (i.e., study duration) Was diagnosed with depression and/or started or significantly altered their depression treatment, including starting a pharmacological therapy or beginning therapy, in the previous 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Learning Skills Together Intervention<br>Complex care psychoeducation training intervention for family caregivers | Behavioral: Learning Skills Together Intervention<br>* Learning Skills Together is a 6-week psychoeducational intervention developed to improve caregivers' confidence when completing complex care tasks (e.g., using a gait belt). Participants are asked to attend six 1.5-hour Zoom-delivered group discussion sessions once per week, which cover topics such as how to communicate with someone who is living with dementia, medication management, and home safety. Participants are also provided with a workbook that accompanies each lesson, and includes short readings, videos, additional resources, as well as weekly practice and reflection exercises.<br>|
| Active Comparator: Caregiver Healthy Living Intervention<br>Healthy living intervention for family caregivers | Behavioral: Caregiver Healthy Living Intervention<br>* Participants in the Caregiver Healthy Living Intervention will participate in a 6-week educational intervention to help improve caregiver health behaviors (e.g., getting enough sleep). Participants are asked to attend six 1.5-hour Zoom-delivered group discussion sessions once per week, which cover topics such as how to eat a healthy diet, getting enough physical activity, and taking care of mental health. Participants are also provided a workbook that includes short readings and additional resources.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Caregiver Self-Efficacy | Self-efficacy will be measured using the 8-item Caregiver Self-Efficacy Scale (CSES-8; α=0.88 to 0.89; Ritter et al., 2020) Participants are asked to rate on a scale of 1 to 10 how confident they are with 8 aspects of caregiving (e.g., controlling upsetting thoughts). Scores range from 8 to 80, where higher scores indicate higher levels of caregiver self-efficacy. The outcome measure will use the average change score from baseline scores until each post-intervention survey (i.e., post-intervention, 3 months post-intervention, 6 months post-intervention). | Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention) | 
| Change in Caregiver Self-Efficacy with Complex Care (Author Generated) | The investigators developed a caregiver complex care self-efficacy measure based upon discussions with healthcare faculty (Meyer et al., 2022). This 16-item scale asks about how confident caregivers feel with various complex care tasks (e.g., Managing incontinence issues) and asks caregivers to rate their confidence from 0 (Not at all confident) to 5 (Very confident). Pilot data showed high internal consistency (α=0.89). Higher scores indicate higher levels of self-efficacy with complex care tasks. The outcome measure will use the average change score from baseline scores until each post-intervention survey (i.e., post-intervention, 3 months post-intervention, 6 months post-intervention). | Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention) | 
| Change in Caregiver Self-Efficacy with Complex Care | Self-efficacy with complex care will also be measured using the Caregiver Confidence in Sign/Symptom Management Scale (α=0.91), which subscales for Knowledge of Symptoms (α=0.56), Management of Cognitive Symptoms (α=0.82), Management of Medical Symptoms (α=0.78), and General Medical Management (α=0.94). Caregivers are asked how true statements are regarding their 1) knowledge, 2) ability to care for, and 3) make decisions about complex care tasks, as well as their level of confidence with various tasks. Scores range from 25 to 125, where higher scores indicate higher levels of caregiver self-efficacy with complex care. The outcome measure will use the average change score from baseline scores until each post-intervention survey (i.e., post-intervention, 3 months post-intervention, 6 months post-intervention). | Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Caregiver 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 each post-intervention survey (i.e., post-intervention, 3 months post-intervention, 6 months post-intervention). | Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention) | 
| Change in Caregiver Depressive Symptomology | Depression will be measured with the Patient Health Questionnaire-9 (PHQ-9). (Kroenke et al., 2001) The PHQ-9 demonstrates specificity and sensitivity at 74-88% and 88-91%, respectively, for major depression with a cutoff score of 10. (Arroll et al., 2010; Kroenke et al., 2001). Scores range from 0 to 27, where higher scores indicate higher levels of depressive symptomology. The outcome measure will use the average change score from baseline scores until each post-intervention survey (i.e., post-intervention, 3 months post-intervention, 6 months post-intervention). | Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention) | 
| Appraisal of Behavioral Symptoms of Dementia | Appraisal of behavioral symptoms of dementia will be measured with the Revised Memory and Behavior Checklist (RMBC). The RMBC includes 24-items and asks about caregiver appraisal of behavioral and psychological symptoms of dementia (e.g., Talking loudly or rapidly; α=0.90; Teri et al., 1992). Participants may indicate whether they feel Extremely bothered or upset, Very much bothered or upset, Moderately bothered or upset, A little bothered or upset, Not at all bothered or upset, Did not occur in the past week. Scores range from 0 to 96, wherein higher scores indicate higher levels of bother (more negative appraisal of behavioral symptoms of dementia). The outcome measure will use the average change score from baseline scores until each post-intervention survey (i.e., post-intervention, 3 months post-intervention, 6 months post-intervention). | Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention) | 
| Change in Quality of Care | 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. The outcome measure will use the average change score from baseline scores until each post-intervention survey (i.e., post-intervention, 3 months post-intervention, 6 months post-intervention). | Change from baseline to post-intervention survey 1 (within 2 weeks of completion); change from baseline to post-intervention survey 2 (3 months post-intervention); change from baseline to post-intervention survey 3 (6 months post-intervention) |