An interventional study of Connect for Caregivers in Social Isolation and Loneliness, sponsored by University of Rochester. Withdrawn at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-10.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
The purpose of this research study is to culturally adapt a personalized intervention for Hispanic/Latino caring for a loved one with significant memory problems. The intervention will be designed to help Hispanics/Latinos caring for a loved one with significant memory problems in their own unique context to: 1.) understand the importance of social connections for their own health and well-being, 2.) learn to become aware of their own personal barriers to social connections, and 3.) increase their knowledge of local resources for promoting social connections.
University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Connect for Caregivers
The STAR Center developed Connect for Caregivers to help improve connectedness among older caregivers of individuals with Alzheimer's Disease and Related Dementias (ADRD). Connect for Caregivers includes three components: (1) psychoeducational materials on the importance of connectedness for health and well-being; (2) a card sort-based 'discussion prioritization tool' that systematizes and routinizes the process of identifying and prioritizing barriers to connectedness; (3) personalized resources to address the identified barriers/targets. We will tailor Connect for Caregivers for Hispanic/Latino and Spanish-speaking caregivers guided by the Selective and Directed Treatment Adaptation Framework. The intervention is given once during the study.
Change from Baseline in Basic Psychological Need Satisfaction at Post Intervention
The Basic Psychological Need Satisfaction and Frustration Scales (BPNSFS) will be used. The BPNSFS consists of 24 items assessing both satisfaction and frustration in the need for competence, autonomy, and relatedness, as posited by Self-Determination Theory. We will report changes in the three BPNSFS subscales measuring satisfaction in: autonomy, relatedness and competence. Items are scored on a 1-5 Likert scale with each subscale score ranging from 4-20. Higher scores indicating greater satisfaction. Mean change in subscale scores (change = post intervention scores - baseline scores) will be reported.
Time frame: Baseline and 1 hour
Change from Baseline in Basic Psychological Need Frustration at Post Intervention
The Basic Psychological Need Satisfaction and Frustration Scales (BPNSFS) will be used. The BPNSFS consists of 24 items assessing both satisfaction and frustration in the need for competence, autonomy, and relatedness, as posited by Self-Determination Theory. We will report changes in the three BPNSFS subscales measuring frustration in: autonomy, relatedness and competence. Items are scored on a 1-5 Likert scale with each subscale score ranging from 4-20. Higher scores indicating greater frustration. Mean change in subscale scores (change = post intervention scores - baseline scores) will be reported.
Time frame: Baseline and 1 hour
Change from Baseline in Ability to Participate in Social Roles and Activities at Post Intervention
The PROMIS Ability to Participate in Social Roles and Activities measure will be used. This scale assesses the perceived ability to perform one's usual social roles and activities. The scale is administered as a computerized adaptive test (CAT) based on a 35 item bank; items are scored on a 1-5 Likert scale. Items are worded negatively in terms of perceived limitations, but responses are reverse-coded. CAT raw scores are converted into T-scores (0-100), with higher scores representing fewer limitations (better abilities). Mean change in T-scores (change = post intervention scores - baseline scores) will be reported.
Time frame: Baseline and 1 hour
Change from Baseline in General Self-Efficacy Score at Post Intervention
The PROMIS General Self-Efficacy measure will be used. This scale assesses confidence in one's ability to perform specific tasks or behaviors. The scale is administered as a computerized adaptive test (CAT) based on a 10 item bank; items are scored on a 1-5 Likert scale. CAT raw scores are converted into T-scores (0-100), with higher scores indicating greater self-efficacy. Mean change in T-scores (change = post intervention scores - baseline scores) will be reported.
Time frame: Baseline and 1 hour
Plan to share: No
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This study is withdrawn, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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