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Clinical Trials/NCT06421545
NCT06421545CompletedNot Applicable

Resilient Together for Dementia: A Live Video Resiliency Dyadic Intervention for Persons With Dementia and Their Care-partners Early After Diagnosis

Icahn School of Medicine at Mount Sinai2 sites in 1 country12 target enrollmentStarted: April 19, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
2
Primary Endpoint
Proportion of potential eligible participants

Study Overview

Brief Summary

The proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, Resilient Together for Dementia (RT-D), aimed at preventing chronic emotional distress and preserving quality of life among dyads at risk for chronic emotional distress early after a diagnosis of Alzheimer's disease or a related dementia (ADRD).

Detailed Description

Both persons living with dementia (PWDs) and their spousal care-partners experience high levels of clinically elevated emotional distress, which can become chronic without treatment and negatively impact the health, quality of life, communication, and care-planning of both partners. A tailored dyadic intervention, such as the proposed Resilient Together for Dementia, delivered over live video to this at risk population during the window of opportunity when PWDs can participate has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • patient is deemed inappropriate by the neurology team,
  • either partner has a co-occurring terminal illness,
  • patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., Frontotemporal Dementia- behavioral variant), as determined by treatment team.

Outcomes

Primary Outcomes

Proportion of potential eligible participants

Time Frame: After each dyad completion, throughout study of 1.5-2 months

Feasibility of recruitment - Recruitment will be monitored by screening clinic visits for potentially eligible individuals and review recruitment progress in weekly meetings to promote completion within the study time frame. Recruitment will be monitored but will not set official benchmarks and modify procedures after each dyad.

Secondary Outcomes

  • Proportion of sessions participants attend(After each dyad completion, throughout study of 1.5-2 months)
  • Proportion of participants screened(After each dyad completion, throughout study of 1.5-2 months)
  • Proportion of participants who consent or not consent to participate(After each dyad completion, throughout study of 1.5-2 months)
  • Change in Hospital Anxiety and Depression Scale (HADS)(Baseline and 6 weeks (post-intervention))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sarah Bannon

Assistant Professor

Icahn School of Medicine at Mount Sinai

Study Sites (2)

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Resilient Together for Dementia | Clinical Trial