Resilient Together for Dementia

Alzheimer's Disease and Related Dementias Clinical Trial

— RT-D ADRD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06421545
• Other study ID #: GCO 23-0519
• Secondary ID: 1K23AG075188-01A
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2024
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Sarah M Bannon, PhD
• Phone: 212-241-0787
• Email: sarah.bannon[@]montsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease and Related Dementias
• Dementia

Intervention

Behavioral:
• Resilient Together for Dementia
A novel live video dyadic resiliency intervention

Locations

Country	Name	City	State
United States	Brain Injury Research Center at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of potential eligible participants	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.	After each dyad completion, throughout study of 1.5-2 months
Secondary	Proportion of participants screened	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.	After each dyad completion, throughout study of 1.5-2 months
Secondary	Proportion of participants who consent or not consent to participate	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.	After each dyad completion, throughout study of 1.5-2 months
Secondary	Proportion of sessions participants attend	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.	After each dyad completion, throughout study of 1.5-2 months
Secondary	Change in Hospital Anxiety and Depression Scale (HADS)	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.	Baseline and 6 weeks (post-intervention)