## Protocol Section
### Identification Module
**NCT ID:** NCT03881579

**Brief Title:** Supportive Care for Cognitively Impaired Patients and Families

**Official Title:** Supportive Care for Cognitively Impaired Patients and Families

#### Organization Study ID Info
**ID:** 48000
#### Organization
**Class:** OTHER
**Full Name:** Stanford University
#### Secondary ID Infos
**ID:** R01AG062239-01
**Link:** https://reporter.nih.gov/quickSearch/R01AG062239-01
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-08

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-04

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-12-18

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2019-03-19
**Type:** ACTUAL
**Study First Submit Date:** 2018-10-08
**Study First Submit QC Date:** 2019-03-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

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

#### Lead Sponsor

**Class:** OTHER

**Name:** Stanford University

#### Responsible Party

**Investigator Affiliation:** Stanford University

**Investigator Full Name:** VJ Periyakoil

**Investigator Title:** Director. Palliative Care Education & Training

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Currently almost 5 million Americans suffer from the distressing symptoms related to dementia and this number that will triple by 2050. The overall goals of the proposed project are to evaluate, in community dwelling Alzheimer's Disease Research Center participants the benefits of a 12-month nurse-led early palliative intervention on symptoms, quality of life, health care resource use. The relevance of this research to public health is that there is an urgent need to improve the palliative care of persons with dementia living in the community. This study will contribute substantially to that effort.

**Detailed Description:** 200 ADRC participants will be recruited and randomized 100 each to usual care (UC) or {usual care plus an early palliative care intervention} (EPC) to be delivered by a nurse over a twelve-month period. The EPC will include one nurse-led palliative consult for a two-hour virtual session followed by 11 monthly 30-minute phone/video sessions plus usual care. The study aims are to determine whether EPC will lead to (a) eliciting and alleviating the supportive care needs of patients, (b) help them complete and sign (with witnesses) their Advance Directives and the POLST (signed by the patient/proxy and their doctor) upload these into the electronic health records. Exploratory outcomes will include health resource use (e.g. hospital admissions and days, emergency visits) for the participants and caregiver burden for their caregivers. Mixed-methods framework will be utilized to analyze the audiotapes of the encounters between the research nurse and the patient during the twelve intervention sessions and to assess whether the information that is provided to participants differs by patient ethnicity and cognitive levels.

### Conditions Module

**Conditions:**

- Dementia

- Primary Palliative Care

- Mild Cognitive Impairment

**Keywords:**

- palliative

- supportive

- MCI

- palliative care

- supportive care

- serious illness

- RCT

- randomized clinical trial

- mild cognitive impairment

- primary palliative care

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** patients will be randomized to one of two groups:

1. (usual care) or (2). enhanced usual care i.e. usual care plus supportive care provided by a trained and supervised nurse

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Outcomes will be assessed by blinded research associates

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 200

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** one random half of patients will receive usual care

**Intervention Names:**

- Behavioral: nurse-led supportive care assessment

**Label:** Usual care

**Type:** OTHER

#### Arm Group 2

**Description:** one random half of patients will receive enhanced usual care (usual care plus nurse-led supportive care intervention)

**Intervention Names:**

- Behavioral: nurse-led supportive care assessment

**Label:** intervention arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Usual care

- intervention arm

**Description:** Trained project nurses will conduct systematic assessment and provide coaching to patients in the experimental arm

**Name:** nurse-led supportive care assessment

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Only the participants randomized to the intervention arm will receive the nurse-led supportive care intervention (one session per month over a twelve-month period).

We hypothesize that compared to the control arm, many more patients in the intervention arm will express supportive needs and have them fulfilled by the study nurses.

**Measure:** To identify the number of participants who express supportive care needs in both arms.

**Time Frame:** Day 0, 4 months, one year

**Description:** In both arms the investigators will track the completion, signage and documentation of advance directives and the POLST. AD has to be signed by the patient or proxy and witnessed by two qualifying witnesses. The POLST has to be signed by the patient/proxy and the patient's doctor. Both forms have to be uploaded into the electronic health records.

**Measure:** Completion and documentation of advance directives (AD) and the Physicians Orders for Life Sustaining Treatment (POLST) in the electronic health records.

**Time Frame:** Day 0, 4 months, one year, 18 months

**Description:** The Zarit Burden Interview contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always) . The factor structure is a two-factor model, addressing personal strain and role strain. The investigators will assess change in Zarit scores between three points in time : on study entry, one year later and two year later.

**Measure:** Change in Zarit Caregiver Burden scores over time:

**Time Frame:** Day 0, 4 months, one year, 18 months

#### Secondary Outcomes

**Description:** The ESAS is designed to assist in the assessment of nine symptoms common in patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing and shortness of breath, (there is also a line labelled "Other Problem"). The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity. The investigators will assess change in ESAS score of all participants at baseline, months 4, 12 and 18. The investigators hypothesize that patients with cognitive impairment will have higher scores than those with normal cognition. The investigators will also determine changes in the ESAS score (if any) over time.

**Measure:** Differences in Edmonton Symptoms Assessment Scale (ESAS) scores

**Time Frame:** Day 0, 4 months, one year, 18 months

**Description:** 3-item survey that assesses a person's underlying knowledge, skills and confidence integral to managing his or her own health and healthcare.

PAM segments individuals into one of four activation levels along an empirically derived 100-point scale. Each level provides insight into an extensive array of health-related characteristics, including attitudes, motivators, and behaviors. Individuals in the lowest activation level do not yet understand the importance of their role in managing their own health, and have significant knowledge gaps and limited self-management skills. Individuals in the highest activation level are proactive with their health, have developed strong self-management skills, and are resilient in times of stress or change. PAM measures patient activation and agency: The investigators will assess changes in activation scores in ESAS scores between three points in time : on study entry, one year later and two year later.

**Measure:** Change in Patient Activation Measure over time

**Time Frame:** one year, two years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* All patients enrolled in the Stanford Alzheimers Disease Research Center (SADRC).
* All caregivers enrolled in the Stanford Alzheimers Disease Research Center (SADRC).

Exclusion Criteria:

1. Institutionalized (not a community dweller) at the time of entry into the study;
2. Have severe dementia and are incapable of responding to the outcome measures at baseline. 3. Participants who live alone and don't have a proxy will be excluded only if they are deemed as lacking the capacity to provide informed consent at the time of entry into the study.

**Minimum Age:** 65 Years

**Sex:** ALL

**Standard Ages:**

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Palo Alto

**Country:** United States

**Facility:** VJ Periyakoil

**State:** California

**Zip:** 94304

#### Overall Officials

**Official 1:**

**Affiliation:** Stanford University

**Name:** VJ Periyakoil, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** by emailing study team

**Description:** this will depend on if patients consent or not for release of data

**Info Types:**

- STUDY_PROTOCOL

- SAP

**IPD Sharing:** YES

**Time Frame:** after study completion

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000003072

- Term: Cognition Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M29705

- Name: Cognitive Dysfunction

- Relevance: HIGH

- As Found: Mild Cognitive Impairment

- 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: M6301

- Name: Cognition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000060825

- Term: Cognitive Dysfunction

### Misc Info Module

- Version Holder: 2024-05-24
