Supportive Care for Dementia

Overseen By VJ Periyakoil, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Institutionalized, Severe dementia, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a nurse-led supportive care approach can improve life for people with dementia living at home. Researchers aim to determine if this method better addresses symptoms, daily life quality, and healthcare needs compared to usual care. Participants will either continue with their usual care or receive additional nurse support. The trial seeks individuals and their caregivers who are already part of the Stanford Alzheimer's Disease Research Center and live in the community. As an unphased trial, this study offers participants the chance to contribute to innovative care strategies that could enhance the quality of life for those living with dementia.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this nurse-led supportive care assessment is safe for dementia patients?

Research has shown that nurse-led care is generally safe for people with dementia. Studies have found that these programs can improve the quality of life for both patients and their caregivers. These studies mention no specific safety concerns or negative effects.

Nurse-led care proves more effective than standard care in reducing symptoms like depression and improving overall well-being. While the studies focus on benefits, they report no major safety issues, suggesting that the treatment is well-tolerated.

Overall, nurse-led supportive care appears to be a promising and safe approach for those living with dementia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about nurse-led supportive care for dementia because it offers a more personalized approach compared to traditional treatments. While standard care typically involves medications and general support, this method enhances usual care with a specialized intervention where nurses assess and address the specific needs of patients. This hands-on, tailored approach has the potential to improve quality of life for patients and provide more targeted support, making it a promising development in dementia care.

What evidence suggests that this nurse-led supportive care assessment is effective for dementia?

Research has shown that nurse-led care can be very helpful for people with dementia. In this trial, one group of participants will receive enhanced usual care, which includes a nurse-led supportive care intervention. A program run by community nurses has greatly improved caregivers' ability to provide care, enhanced quality of life, and reduced stress for patients. When nurses take on extended roles, both patients and their caregivers experience better treatment and care outcomes. Studies have found that nurse-led care is more effective than standard care at reducing depression and improving quality of life. Additionally, providing extra support early on helps patients manage daily activities better. Overall, these findings suggest that nurse-led care could be a promising way to manage dementia symptoms and improve life for both patients and their caregivers. ^{1 4 5 6 7}

Who Is on the Research Team?

VJ Periyakoil, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for community-dwelling patients with dementia who are enrolled in the Stanford Alzheimer's Disease Research Center, along with their caregivers. It excludes those who are institutionalized, have severe dementia preventing them from responding to outcome measures, or lack a caregiver if unable to consent.

Inclusion Criteria

All caregivers involved with the Stanford Alzheimer's Disease Research Center (SADRC).

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

Exclusion Criteria

I can make my own medical decisions and do not need a proxy.

I have severe dementia and cannot respond to basic questions or instructions.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a nurse-led early palliative care intervention over a twelve-month period, including one initial virtual session followed by 11 monthly phone/video sessions

12 months

1 virtual visit, 11 phone/video sessions

Follow-up

Participants are monitored for completion and documentation of advance directives and POLST, as well as changes in supportive care needs, ESAS scores, and caregiver burden

6 months

What Are the Treatments Tested in This Trial?

Interventions

• nurse-led supportive care assessment

Trial Overview The study tests a nurse-led supportive care assessment over 12 months aimed at improving symptoms and quality of life for people with dementia. The goal is also to reduce health care resource use by providing early palliative interventions.

How Is the Trial Designed?

Group I: intervention arm Experimental Treatment 1 Intervention

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

Group II: Usual care Experimental Treatment 1 Intervention

one random half of patients will receive usual care

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study of 710 older patients (aged over 70) admitted to a hospital, 8.6% experienced reported adverse events (RAEs), with patient-related incidents linked to factors like male gender, delirium, and cognitive impairment.

Despite the high incidence of RAEs, which occurred at a rate of 2.1 per person year, these events were not associated with increased mortality during the hospital stay, as 11.1% of patients died regardless of RAE occurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective cohort study of adverse events in older people admitted to the acute general hospital: risk factors and the impact of dementia. Watkin, L., Blanchard, MR., Tookman, A., et al.[2021]

Hospital-acquired complications like urinary tract infections, pressure areas, pneumonia, and delirium account for 6.4% of total hospital costs for patients over 50, with dementia patients experiencing these complications at a significantly higher rate (RR 2.5).

These complications lead to an eightfold increase in hospital length of stay and double the average episode cost, highlighting the need for improved care models to prevent such issues, especially in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. Bail, K., Goss, J., Draper, B., et al.[2022]

Patients with dementia (n = 240) experienced significantly more adverse events during hospitalization, including falls, delirium, and incontinence, compared to those without dementia.

While patients with dementia received more allied health therapies like speech and physiotherapy, they did not show significant functional improvement, highlighting the need for tailored care models to address their unique health care needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events, Functional Decline, and Access to Allied Health Therapies for Patients With Dementia During Acute Hospitalization. Fox, A., MacAndrew, M., Wyles, K., et al.[2021]

A nurse-led medication monitoring program in three care homes for 11 dementia patients was feasible, identifying an average of 12.7 previously undocumented medication-related problems per participant, which were addressed through new prescriptions and care plans.

The intervention caused no harm and showed clinical benefits, with some issues ameliorated after one month, highlighting the importance of structured monitoring in improving medication safety for individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication monitoring for people with dementia in care homes: the feasibility and clinical impact of nurse-led monitoring. Jordan, S., Gabe, M., Newson, L., et al.[2021]

The introduction of the West Wales ADR Profile for Mental Health Medicines significantly increased the number of clinical problems addressed in dementia patients, from an average of 6.02 to 9.86, indicating improved monitoring and care.

Using the ADR Profile led to a reduction in the prescribing of mental health medications, suggesting it can enhance the safety and quality of care for individuals with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial. Jordan, S., Gabe-Walters, ME., Watkins, A., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10657713/

The Effectiveness of a Community Nurse-Led Support ... The community nurse-led support program significantly improved caregivers' competency in providing dementia care and quality of life and reduced distress.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12556587/

Efficacy and cost‐effectiveness of extended nursing roles ... Extended nursing roles in dementia can improve treatment, care, and patient and caregiver outcomes. We tested the efficacy and ...

3. researchgate.net researchgate.net/profile/Ita-Saragih/publication/375255227_Systematic_Review_and_Meta-Analysis_of_Effects_of_Nurse-Led_Intervention_for_People_With_Dementia/links/654c512eb1398a779d727557/Systematic-Review-and-Meta-Analysis-of-Effects-of-Nurse-Led-Intervention-for-People-With-Dementia.pdf

Systematic Review and Meta-Analysis of Effects of Nurse- ... Results: Nurse-led interventions were more effective than standard care in alleviating depression and improving quality of life. However, they did not enhance ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0883941724000633

Effectiveness of a health education program for people with ... This study assesses the effectiveness of a health education program on caregiving outcomes for people with dementia and their families.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0020748925001117

The effect of nurse-led enhanced supportive care as an ... Nurse-led enhanced supportive care as an early primary palliative care approach has demonstrated effectiveness in improving the role functioning domain of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12004474/

Randomised controlled trial of a nurse coordination ... This randomised control trial will test the effectiveness and cost effectiveness of a dementia nurse-led intervention to: (1) increase days ...

7. ejgg.org ejgg.org/articles/challenges-of-providing-nursing-care-to-patients-with-dementia-a-qualitative-study/ejgg.galenos.2022.2022-6-3

Challenges of Providing Nursing Care to Patients with ... The aim of this study was to identify the challenges faced by nurses while providing care to patients with dementia.