Supportive Care for Cognitively Impaired Patients and Families

NCT03881579 | Active Not Recruiting DMC

• 2 other identifiers: 48000R01AG062239-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• To identify the number of participants who express supportive care needs in both arms.

  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.

  Day 0, 4 months, one year

• Change in Zarit Caregiver Burden scores over time:

  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.

  Day 0, 4 months, one year, 18 months

• Completion of goals of care discussion and documentation of advance directives (AD) and the Physicians Orders for Life Sustaining Treatment (POLST) in the electronic health records.

  In both arms the investigators will track the completion, signage and documentation of advance directives and the POLST. We will monitor the EHR to track if the doctor documents goals of care in the chart.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 doctor. Both forms have to be uploaded into the electronic health records.

  Day 0, 4 months, one year, 18 months

Secondary Outcomes (2)

• Differences in Edmonton Symptoms Assessment Scale (ESAS) scores

  Day 0, 4 months, one year, 18 months

• Change in Patient Activation Measure over time

  one year, two years

Study Arms (2)

Usual care

OTHER

one random half of patients will receive usual care

Behavioral: nurse-led supportive care assessment

intervention arm

EXPERIMENTAL

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

Behavioral: nurse-led supportive care assessment

Interventions

nurse-led supportive care assessment BEHAVIORAL

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

Usual care; intervention arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Institutionalized (not a community dweller) at the time of entry into the study;
• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

VJ Periyakoil

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• VJ Periyakoil, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be assessed by blinded research associates
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director. Palliative Care Education & Training

Model Details: 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

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: March 19, 2019
• Study Start: December 18, 2019
• Primary Completion: November 30, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after study completion
• Access Criteria: by emailing study team

Locations

US (1)