Clinical trial NCT06619327: Resilient Together for Dementia (RT-D)
Official title: Resilient Together for Dementia: a Live Video Resiliency Dyadic Intervention for Persons with Dementia and Their Care-partners Early After Diagnosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Keywords: Dementia
Care partners
Dyads
Emotional distress
Quality of life
Couples
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the feasibility and preliminary efficacy of the novel Resilient Together for Dementia (RT-D) intervention for couples following dementia diagnoses. The primary target is emotional distress, and the program aims to prevent chronic distress in at-risk couples.

Detailed description: Both persons living with dementia 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 has the potential to prevent chronic emotional distress and preserve quality of life for PWDs and their loved ones.

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, educational pamphlet). 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 II). 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 criteria: Inclusion Criteria:

* Recent (\~3 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 their problems (as determined by the treating neurologist), and ability to understand study and research protocol, as determined by a standardized teach-back method assessment

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 or \<5 on the Geriatric Depression Scale)

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.

Primary outcomes:
measure: Proportion of participants screened
timeFrame: After each dyad completion, throughout study of 6-8 weeks
measure: Proportion of participants who consent or not consent to participate
timeFrame: After each dyad completion, throughout study of 6-8 weeks
measure: Proportion of sessions participants attend
timeFrame: After each dyad completion, throughout study of 6-8 weeks
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: After each dyad completion, throughout study of 6-8 weeks
measure: Client Satisfaction Questionnaire
timeFrame: After each dyad completion, throughout study of 6-8 weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline to posttest (6-8 weeks)
measure: Geriatric Depression Scale
timeFrame: Baseline to posttest (6-8 weeks)
measure: Perceived Stress Scale
timeFrame: Baseline to posttest (6-8 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Brain Injury Research Center at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Sarah Bannon, PhD
role: PRINCIPAL_INVESTIGATOR
References: