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

200 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment nurse-led supportive care assessment for dementia?

Research shows that nurse-led interventions, like the PROACTIVE Treatment Approach, can improve outcomes for dementia patients by reducing stress and increasing the use of non-drug methods to manage behaviors, leading to shorter hospital stays. ^{1 2 3 4 5}

Is nurse-led supportive care for dementia safe for humans?

Nurse-led supportive care, which includes monitoring medications for people with dementia, has been studied and is generally considered safe. It helps identify and address potential medication-related problems, reducing the risk of adverse drug reactions (unwanted side effects from medicines). ^{6 7 8 9 10}

How is the nurse-led supportive care assessment treatment for dementia unique?

This treatment is unique because it involves a nurse-led approach that focuses on understanding the specific needs of both dementia patients and their caregivers, which is not typically addressed in standard treatments. It emphasizes the importance of caregiver input and aims to provide a more personalized and responsive care plan. ^{4 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

VJ Periyakoil, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nursing interventions to improve care of people with dementia in hospital: a mixed methods systematic review protocol. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a recovery-orientated psychiatric intervention package on the wellbeing of people with early dementia: a preliminary randomised controlled trial. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of an Acute Care Multicomponent Intervention for Dementia-Related Behavioral Expressions. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The role of the dementia specialist nurse in acute care: a scoping review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Challenging behaviours in nursing home residents with dementia: a randomized controlled trial of multidisciplinary interventions. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Medication monitoring for people with dementia in care homes: the feasibility and clinical impact of nurse-led monitoring. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Nurse-Led Medicines' Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial. [2018]

8. England pubmed.ncbi.nlm.nih.gov

The cost of hospital-acquired complications for older people with and without dementia; a retrospective cohort study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse Events, Functional Decline, and Access to Allied Health Therapies for Patients With Dementia During Acute Hospitalization. [2021]

10. England 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. [2021]

11. England pubmed.ncbi.nlm.nih.gov

The carer-led assessment process (CLASP): a framework for the assessment of need in dementia caregivers. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Confidence in dementia care and care approach toward dementia among the nursing staff in long-term care facilities in China: a cross-sectional survey. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Development and evaluation of the content validity, practicability and feasibility of the Innovative dementia-oriented Assessment system for challenging behaviour in residents with dementia. [2019]

14. England pubmed.ncbi.nlm.nih.gov

Process evaluation of the response of nursing homes to the implementation of the dementia-specific case conference concept WELCOME-IdA: A qualitative study. [2022]