## Protocol Section
### Identification Module
**NCT ID:** NCT06421545

**Acronym:** RT-D ADRD

**Brief Title:** Resilient Together for Dementia

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

#### Organization Study ID Info
**ID:** GCO 23-0519
#### Organization
**Class:** OTHER
**Full Name:** Icahn School of Medicine at Mount Sinai
#### Secondary ID Infos
**ID:** 1K23AG075188-01A1
**Link:** https://reporter.nih.gov/quickSearch/1K23AG075188-01A1
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-19

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-30
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute on Aging (NIA)

#### Lead Sponsor

**Class:** OTHER

**Name:** Icahn School of Medicine at Mount Sinai

#### Responsible Party

**Investigator Affiliation:** Icahn School of Medicine at Mount Sinai

**Investigator Full Name:** Sarah Bannon

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

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.

### Conditions Module

**Conditions:**

- Alzheimer's Disease and Related Dementias

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: Resilient Together for Dementia

**Label:** Open Pilot RT-D Dyads

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Open Pilot RT-D Dyads

**Description:** A novel live video dyadic resiliency intervention

**Name:** Resilient Together for Dementia

**Other Names:**

- RT-D

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Proportion of potential eligible participants

**Time Frame:** After each dyad completion, throughout study of 1.5-2 months

#### Secondary Outcomes

**Description:** 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.

**Measure:** Proportion of participants screened

**Time Frame:** After each dyad completion, throughout study of 1.5-2 months

**Description:** 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.

**Measure:** Proportion of participants who consent or not consent to participate

**Time Frame:** After each dyad completion, throughout study of 1.5-2 months

**Description:** 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.

**Measure:** Proportion of sessions participants attend

**Time Frame:** After each dyad completion, throughout study of 1.5-2 months

**Description:** 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.

**Measure:** Change in Hospital Anxiety and Depression Scale (HADS)

**Time Frame:** Baseline and 6 weeks (post-intervention)

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sarah.bannon@montsinai.org

**Name:** Sarah M Bannon, PhD

**Phone:** 212-241-0787

**Role:** CONTACT

**Contact 2:**

**Name:** Sydney M McCage, MA

**Phone:** 212-241-6866

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** sarah.bannon@mountsinai.org

- **Name:** Sarah Bannon, PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Sarah Bannon

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Brain Injury Research Center at Mount Sinai

**State:** New York

**Status:** RECRUITING

**Zip:** 10029

#### Overall Officials

**Official 1:**

**Affiliation:** Icahn School of Medicine at Mount Sinai

**Name:** Sarah Bannon

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Anyone who wishes to access the data. Any purpose. Data are available indefinitely at (Link tbd).

**Description:** All of the individual participant data collected during the trial, after deidentification.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

**Time Frame:** Immediately following publication. No end date.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000024801

- Term: Tauopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M6904

- Name: Dementia

- Relevance: HIGH

- As Found: Dementia

- ID: M3885

- Name: Alzheimer Disease

- Relevance: HIGH

- As Found: Alzheimer's Disease

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23002

- Name: Tauopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T2192

- Name: Familial Alzheimer Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000544

- Term: Alzheimer Disease

- ID: D000003704

- Term: Dementia

### Misc Info Module

- Version Holder: 2024-05-31
