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Resilient Together for Dementia

Recruiting
65 years of age
Both
Phase N/A

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Overview

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).

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.

In the Intervention Phase (Aims 2 and 3), an open pilot (N=5 dyads) of the newly developed RT-D followed by exit interviews will be conducted to explore the initial feasibility and acceptability of the adapted protocol and to further refine the intervention content, materials, and procedures (Aim 2; NIA Stage 1A). Next, a pilot feasibility randomized control trial (RCT; Aim 3; NIA Stage 1B; N=50 dyads) will be conducted of the refined RT-D versus a minimally enhanced educational control (MEUC). Primary outcomes will be feasibility, credibility, and acceptability markers to inform a hybrid efficacy effectiveness R01 (year 4) of RT-D vs. MEUC (NIA Stage III). In this subsequent R01, the researcher will examine RT-D's impact on emotional distress and quality of life outcomes and test mechanisms of change (individual and interpersonal resiliency skills) through mediation and moderation. The researcher will revise the approach if feasibility benchmarks are not met.

Eligibility

PWD inclusion criteria are:

  • Recent (~1 month) chart documented ADRD diagnosis,
  • ADRD symptom onset after age 65 ,
  • cognitive assessment scores and symptoms consistent with early stage dementia, as determined by the Clinical Dementia Rating Scale scores of .5 or 1.0
  • cognitive awareness of his/her problems (as determined by the treating neurologist), and
  • ability to understand study and research protocol, as determined by a standardized teach-back method assessment84.

Additional inclusion criteria for dyads are:

  • English speaking adults (18 years or older),
  • dyad lives together,
  • at least one partner endorses clinically significant emotional distress during screening (>7 on Hospital Anxiety and Depression scale subscales)

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 details

Alzheimer's Disease and Related Dementias

NCT06421545

Icahn School of Medicine at Mount Sinai

26 May 2024

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