MedPath

Resilient Together for Dementia

Not Applicable
Completed
Conditions
Alzheimer's Disease and Related Dementias
Interventions
Behavioral: Resilient Together for Dementia
Registration Number
NCT06421545
Lead Sponsor
Icahn School of Medicine at Mount Sinai
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Open Pilot RT-D DyadsResilient Together for DementiaPersons living with dementia (PWDs) and their spousal care-partners
Primary Outcome Measures
NameTimeMethod
Proportion of potential eligible participantsAfter 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 Outcome Measures
NameTimeMethod
Proportion of sessions participants attendAfter each dyad completion, throughout study of 1.5-2 months

Feasibility of treatment -The number of sessions that enrolled dyads attend as well as missed sessions, treatment dropouts, and reasons for non attendance will be monitored and will review progress in weekly meetings. Feasibility of treatment will be monitored but will not set official benchmarks and modify procedures after each dyad.

Proportion of participants screenedAfter each dyad completion, throughout study of 1.5-2 months

Feasibility of screening - the portion of individuals who undergo screening that screen eligible and ineligible, and the reasons for ineligibility with detailed descriptions will be monitored and will review progress in weekly team meetings. Screening will be monitored but will not set official benchmarks and modify procedures after each dyad.

Proportion of participants who consent or not consent to participateAfter each dyad completion, throughout study of 1.5-2 months

Feasibility of consent by keeping a record of all individuals who complete screening that consent, refuse to consent, and the reasons for refusal will be monitored and will review progress in weekly team meetings. Feasibility of consent will be monitored but will not set official benchmarks and modify procedures after each dyad.

Change in Hospital Anxiety and Depression Scale (HADS)Baseline and 6 weeks (post-intervention)

Change in emotional distress assessed with the Hospital Anxiety and Depression Anxiety Scale which is a 14-items scale with responses scored from 0-3, scores for each subscale (anxiety and depression) from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.

Trial Locations

Locations (1)

Brain Injury Research Center at Mount Sinai

🇺🇸

New York, New York, United States

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