Video Program for Alzheimer's Disease

(RT-D ADRD Trial)

Overseen By Sydney M McCage, MA

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Terminal illness, Frontotemporal dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new video program called Resilient Together for Dementia. The goal is to determine if this program can help people with Alzheimer's or related dementia and their partners cope better emotionally and maintain their quality of life. It targets those recently diagnosed with Alzheimer's after age 65 who are still in the early stages. Participants should live with their partners, and at least one partner should experience significant emotional distress. The trial aims to provide support and build resilience for both patients and their spouses. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance emotional support for those affected by dementia.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this video program is safe for individuals with Alzheimer's disease?

Research has shown that the Resilient Together for Dementia program is designed to help people with Alzheimer's and their partners by reducing stress and improving quality of life. This program does not involve medication; instead, it uses video sessions to support both the person with dementia and their caregiver.

Regarding safety, no evidence suggests any risk, as the program does not use drugs or involve medical procedures. It focuses on learning and support, which are generally safe. The study is in a phase called "Not Applicable," indicating minimal safety concerns. This trial primarily aims to assess participants' satisfaction with the program and its benefits.

In summary, joining this trial appears safe because it emphasizes emotional support rather than medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

"Resilient Together for Dementia" is unique because it offers a video-based program that supports both individuals living with dementia and their spousal care-partners. Unlike traditional pharmacological treatments, which primarily focus on slowing the cognitive decline in patients, this approach emphasizes enhancing emotional and psychological resilience for both parties involved. Researchers are excited about this program because it empowers care-partners with coping strategies and strengthens the bond between them, potentially improving the quality of life for both partners. This holistic approach might complement existing medical treatments and address emotional and relational aspects often overlooked by current options.

What evidence suggests that the Resilient Together for Dementia program is effective for Alzheimer's disease?

Research has shown that the Resilient Together for Dementia (RT-D) program, which participants in this trial will experience, aims to improve the emotional well-being and quality of life for people with Alzheimer's and their caregiving spouses. Although specific data on its effectiveness is limited, the program seeks to reduce emotional stress and enhance relationships. Early results suggest that focusing on these areas can positively affect those living with dementia. The program uses live video sessions to build resilience, offering a promising way to support both patients and caregivers. While further studies are needed to confirm its effectiveness, the approach is based on enhancing emotional and social support. ^{1 2 4 6 7}

Who Is on the Research Team?

Sarah Bannon

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for pairs (dyads) where one person has early-stage Alzheimer's or related dementia and the other is a caregiver. They should be at risk of chronic emotional distress. Specific eligibility details are not provided, but typically there would be criteria around age, health status, and ability to participate in video sessions.

Inclusion Criteria

Dyad lives together

At least one partner endorses clinically significant emotional distress during screening (>7 on Hospital Anxiety and Depression scale subscales)

I was diagnosed with Alzheimer's or dementia about a month ago.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1.5-2 months

Treatment

Participants receive the Resilient Together for Dementia intervention via live video sessions

6 weeks

Weekly live video sessions

Follow-up

Participants are monitored for changes in emotional distress using the Hospital Anxiety and Depression Scale

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Resilient Together for Dementia

Trial Overview The study tests 'Resilient Together for Dementia', a live video intervention designed to help both the patient with dementia and their caregiver manage emotional stress and maintain quality of life after diagnosis.

How Is the Trial Designed?

Group I: Open Pilot RT-D Dyads Experimental Treatment 1 Intervention

Persons living with dementia (PWDs) and their spousal care-partners

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The updated Dementia Dialogues® program significantly increased caregiver knowledge about Alzheimer's disease and related dementias, as shown by a study of 235 participants from North and South Carolina.

Caregivers showed greater knowledge improvement compared to noncaregivers, indicating that the program effectively educates those directly involved in caring for individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of Dementia Dialogues®: A Program for Informal and Formal Caregivers in North and South Carolina. Byers, MD., Resciniti, NV., Ureña, S., et al.[2022]

With appropriate staff training and orientation, caregivers can better understand and meet the individual needs of advanced dementia patients, enhancing their participation in social and therapeutic activities.

Implementing tailored programs for these patients can improve their quality of life and provide meaningful human contact, even as their cognitive abilities decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working with advanced dementia patients in a day care setting. Abramowitz, L.[2015]

An integrative learning program for people with dementia was developed using the Delphi technique and showed promising results in improving communication, emotions, and overall well-being among participants.

The program was successfully implemented without the need for content modifications, indicating its feasibility and readiness for further research to evaluate its efficacy across multiple centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an integrative learning program for community dwelling old people with dementia. Wong, TKS., Yunhua, Y., Jinghan, C., et al.[2021]

The RDAD program effectively teaches caregivers strategies to enhance mood, behavior, and physical function in individuals with dementia, and has been successfully adapted for use by Area Agencies on Aging in Washington and Oregon.

Modifications to the RDAD program included reducing in-person sessions while maintaining educational content and involving caregivers in exercise activities, demonstrating its flexibility and applicability to a diverse range of cognitive impairments and caregiving situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training Area Agencies on Aging Case Managers to Improve Physical Function, Mood, and Behavior in Persons With Dementia and Caregivers: Examples from the RDAD-Northwest Study. McCurry, SM., Logsdon, RG., Pike, KC., et al.[2019]

The Video Respite program, which includes ten videotapes designed for individuals with dementia, has shown promise in capturing the attention of persons with Alzheimer's disease, allowing caregivers to take necessary breaks.

Early research indicates that caregivers find the videotapes beneficial for respite, and staff report that the tapes have a calming effect on residents, suggesting potential therapeutic value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video Respite: an innovative resource for family, professional caregivers, and persons with dementia. Lund, DA., Hill, RD., Caserta, MS., et al.[2019]

The scoping review identified 12 relevant studies on dementia-friendly initiatives and small-scale homelike facilities, revealing promising but limited evidence that these environments can improve physical functioning, social participation, and quality of life for older adults with dementia compared to traditional nursing homes.

There is a significant lack of quantitative evaluations on the effectiveness of dementia villages, highlighting the need for more comprehensive research to assess the clinical, economic, and social outcomes of these innovative care models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Dementia-Friendly Initiatives, Small-Scale Homelike Residential Care, and Dementia Village Models: A Scoping Review. Krier, D., de Boer, B., Hiligsmann, M., et al.[2023]

The pilot dementia care program successfully enrolled 87 caregiver-patient dyads, indicating its feasibility and potential for implementation in home and virtual settings.

Participants reported high satisfaction levels, suggesting that the personalized support provided by Health Coaches and the interdisciplinary team effectively meets the needs of both persons with dementia and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Development of a Community-Based, Interdisciplinary, Collaborative Dementia Care Program. Goldfarb, D., Allen, AM., Nisson, LE., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10689832

Resilient Together for Dementia PROJECT SUMMARY In this K23 proposal, I outline a comprehensive 5-year training program that will support my transition towards an independent investigator ...

2. trialx.com trialx.com/clinical-trials/listings/291573/resilient-together-for-dementia/

Resilient Together for Dementia | Clinical Research Trial ... Primary outcomes will be feasibility, credibility, and acceptability markers to inform a hybrid efficacy effectiveness R01 (year 4) of RT-D vs.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12281600/

Resilient Together for Dementia: A qualitative study of ... Most persons living with dementia were diagnosed with Alzheimer's disease (n=8; 50%) and were diagnosed an average of 13.69 ± 16.40 (range 1 – 51) months ...

4. researchprotocols.org researchprotocols.org/2025/1/e60382/PDF

Protocol for Open Pilot of Resilient Together for Dementia The primary intervention targets (Table 2, secondary outcomes) are individuals' emotional distress, relationship quality, and quality of life, ...

5. mountsinai.org mountsinai.org/clinical-trials/resilient-together-for-dementia

Resilient Together for Dementia | Mount Sinai - New York Summary: The proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, Resilient ...

6. app.trialscreen.org app.trialscreen.org/trials/resilient-together-dementia-trial-nct06421545

Resilient Together for Dementia This Interventional study is looking for people with Alzheimer's Disease and Related Dementias in New York United States to take part.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06421545/resilient-together-for-dementia

Resilient Together for Dementia | Clinical Research Trial ... The proposed study will establish the feasibility, acceptability and credibility of a novel live video dyadic resiliency intervention, ...