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Clinical Trials/NCT04593628
NCT04593628
Withdrawn
N/A

Adapting 'Connect for Caregivers' for Hispanic Caregivers: A Pilot Study for Year Two of the Rochester Roybal Center for Social Ties and Aging Research (P30AG064103) and the UR Healthy Aging Research Program (HARP)

University of Rochester1 site in 1 countryJanuary 24, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Social Isolation
Sponsor
University of Rochester
Locations
1
Primary Endpoint
Change from Baseline in Basic Psychological Need Satisfaction at Post Intervention
Status
Withdrawn
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 24, 2021
End Date
May 13, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Caroline Silva

Assistant Professor

University of Rochester

Eligibility Criteria

Inclusion Criteria

  • Current or previous Hispanic/Latino caregiver (English or Spanish speaking) for a community-dwelling loved one with ADRD, living with (or in close proximity to) loved one with dementia;
  • Age 40 or older;
  • Able to provide informed consent to participate in the research study.

Exclusion Criteria

  • Primary language is not English or Spanish;
  • Current alcohol or substance abuse, psychotic disorders (current and lifetime), bipolar disorder and current mood disorders with psychotic features (MINI International Neuropsychiatric Interview);
  • Significant cognitive impairment on a cognitive screening measure at the HARP screening assessment (Telephone Interview for Cognitive Status; TICS \< 25);
  • Hearing problems that preclude completion of the study.

Outcomes

Primary Outcomes

Change from Baseline in Basic Psychological Need Satisfaction at Post Intervention

Time Frame: Baseline and 1 hour

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.

Change from Baseline in Basic Psychological Need Frustration at Post Intervention

Time Frame: Baseline and 1 hour

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.

Change from Baseline in Ability to Participate in Social Roles and Activities at Post Intervention

Time Frame: Baseline and 1 hour

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.

Secondary Outcomes

  • Change from Baseline in General Self-Efficacy Score at Post Intervention(Baseline and 1 hour)

Study Sites (1)

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