UPLIFT-AD for Alzheimer's Disease

(UPLIFT-AD Trial)

Overseen By Alex Floyd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Short-stay residents, Non-English-speaking, others

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

Compensation: Varies

Number of Visits: 1

2000 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate a comprehensive model for integrating both primary and specialty Palliative Care for older adults with dementia into nursing facilities. Palliative Care is a supportive care approach that aims to improve the quality of life of patients and their families facing serious or life-threatening illnesses, through the prevention and relief of suffering through the treatment of pain and other problems, using physical, psychosocial and spiritual approaches. Palliative care is specialized medical care for people who are living with a serious illness. This type of care is focused on providing relief from the symptoms and from the stress of the illness. The goal is to improve quality of life for both patient and family. The UPLIFT-AD model will include providing education on primary Palliative Care for residents with dementia to nursing facility staff, training nursing facility staff in providing primary Palliative Care, and providing access to specialty Palliative Care consultations for residents. To help understand the impact of these interventions, this study will also collect information about resident health, the care they receive, and perceptions of their quality of life according to both family members and nursing facility staff.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the UPLIFT-AD treatment for Alzheimer's Disease?

Research suggests that palliative care, which is part of the UPLIFT-AD treatment, can help people with dementia by reducing unnecessary hospital visits and easing symptoms. This approach also supports caregivers by reducing their stress and financial burden. ^{1 2 3 4 5}

Is the UPLIFT-AD treatment safe for humans?

The available research focuses on palliative care for Alzheimer's and related dementias, emphasizing comfort and symptom relief rather than aggressive treatment. There is no specific safety data for UPLIFT-AD, but the studies suggest that palliative care approaches generally do not increase mortality, indicating a focus on safety and comfort. ^{1 2 3 6 7}

Research Team

John Cagle, PhD, MSW

Principal Investigator

University of Maryland, Baltimore

Kathleen T Unroe, MD, MHA

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for long-stay residents in certain nursing homes who have moderate to severe Alzheimer's Disease, as confirmed by the Minimum Data Set (MDS), and have been there for over 30 days. Their family members or decision makers must speak English, as should the nursing facility staff involved.

Inclusion Criteria

I am a long-term resident not using Medicare Part A for payment.

Family member and/or surrogate decision maker for an eligible resident in an enrolled nursing home

I have been diagnosed with moderate to severe Alzheimer's or dementia.

Exclusion Criteria

Non-English-speaking family members/surrogate decision makers

I am a short-stay resident covered by Medicare Part A or receiving respite care.

Nursing facility staff who do not speak English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of the UPLIFT-AD model, including training of in-house PC champions, providing specialty PC consultations, and educating nursing home staff on primary Palliative Care.

18 months

Regular visits for training and consultation

Follow-up

Participants are monitored for changes in palliative care outcomes, staff perceptions, and quality of life measures.

18 months

Periodic assessments at 1, 6, 12, and 18 months

Evaluation

Evaluation of the effectiveness and fidelity of the UPLIFT-AD intervention using various scales and measures.

18 months

Treatment Details

Interventions

• UPLIFT-AD

Trial Overview The study tests UPLIFT-AD, a model integrating primary and specialty Palliative Care into nursing facilities for older adults with dementia. It includes educating staff on Palliative Care, training them to provide it, and offering specialty care consultations.

Participant Groups

Group I: Nursing Home-level UPLIFT-AD intervention Experimental Treatment 1 Intervention

The UPLIFT-AD intervention consists of three major components delivered at the level of the nursing home: 1) in-house PC champions trained to a) facilitate advance care planning conversations with residents with Alzheimer's Disease and Related Dementias and their surrogate decision-makers, b) screen and follow up on residents' Palliative Care needs and c) serve as a liaison to Palliative Care consultants; 2) specialty Palliative Care consultant support providing individual consults for residents with complex Palliative Care needs; and 3) education on primary Palliative Care offered to all clinical NH staff.

Group II: Usual Care Active Control 1 Intervention

Usual nursing home care.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

The ADRD-Palliative Care (ADRD-PC) program is being tested in a randomized clinical trial involving 424 patient-caregiver dyads to evaluate its effectiveness in reducing hospital transfers and improving care for late-stage Alzheimer's disease and related dementias.

The study aims to provide comprehensive dementia-specific palliative care, caregiver education, and transitional care, addressing both patient and caregiver outcomes, including symptom management and caregiver distress, which are critical for improving quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care for persons with late-stage Alzheimer's and related dementias and their caregivers: protocol for a randomized clinical trial. Toles, M., Kistler, C., Lin, FC., et al.[2023]

Patients with dementia receiving specialty palliative care were older and more functionally impaired compared to those with systemic illnesses or cancer, indicating a need for tailored palliative approaches for this demographic.

Dementia patients were more likely to have a 'do not resuscitate/do not intubate' (DNR/DNI) status at discharge, yet reported low levels of distressing symptoms, suggesting that palliative care may effectively align treatment goals with patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inpatients With Dementia Referred for Palliative Care Consultation: A Multicenter Analysis. Goss, A., O'Riordan, DL., Pantilat, SZ.[2022]

The PRO-MADE prognostic model, developed from a study of 1,077 advanced dementia patients, effectively predicts one-year all-cause mortality, identifying key risk factors such as age over 85, male gender, and the presence of pneumonia or pressure ulcers.

With an area-under-the-curve (AUC) of 0.70 during external validation, the model demonstrates good accuracy and can assist clinicians in making timely referrals to palliative care for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting mortality in patients diagnosed with advanced dementia presenting at an acute care hospital: the PROgnostic Model for Advanced DEmentia (PRO-MADE). Kaur, P., Kannapiran, P., Ng, SHX., et al.[2023]

Among 927 hospitalized dementia patients, 17% received inpatient palliative care consultations (IPCC), which were associated with more advanced dementia symptoms, such as delirium and pressure ulcers.

Patients who received IPCC had a significantly longer hospital stay and were more likely to change their code status to 'do not attempt resuscitation' and to be discharged to hospice, indicating that IPCC can facilitate important end-of-life discussions and patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Outcomes of Dementia Patients Who Receive Inpatient Palliative Care Consultation. Sharda, N., Zietlow, K., Wong, S., et al.[2021]

Facilitated case conferencing (FCC) in nursing homes for residents with advanced dementia did not show a significant improvement in family-rated quality of end-of-life care compared to usual care, likely due to an underpowered analysis with only 131 deaths observed.

However, FCC was associated with significant improvements in both pharmacological and non-pharmacological palliative management in the last month of life, suggesting that it can enhance the overall palliative approach despite not affecting the primary outcome measure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of facilitated family case conferencing for advanced dementia: A cluster randomised clinical trial. Agar, M., Luckett, T., Luscombe, G., et al.[2018]

A program designed to limit aggressive medical treatment for patients with advanced Alzheimer's dementia focused on maintaining comfort rather than prolonging life, and it was implemented for 40 patients on an intermediate medical ward.

Preliminary results showed that this approach did not significantly increase mortality in the first year, even though 62% of patients were not treated with antibiotics for infections, indicating that comfort-focused care can be safely administered without compromising survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospice approach to the treatment of patients with advanced dementia of the Alzheimer type. Volicer, L., Rheaume, Y., Brown, J., et al.[2016]

The validated risk score for estimating 6-month mortality in nursing home residents with advanced dementia showed reasonable accuracy, with AUROC values of 0.65 for Dutch residents and 0.64 for US residents, indicating its effectiveness in predicting mortality risk.

The study involved 288 Dutch residents and 269 US residents, and while the risk score generally predicted mortality well, it underestimated mortality in a small group identified as very high risk, suggesting that further refinement may be needed for this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of 6-month mortality in nursing home residents with advanced dementia: validity of a risk score. van der Steen, JT., Mitchell, SL., Frijters, DH., et al.[2007]

References

1. England pubmed.ncbi.nlm.nih.gov

Palliative care for persons with late-stage Alzheimer's and related dementias and their caregivers: protocol for a randomized clinical trial. [2023]

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

Inpatients With Dementia Referred for Palliative Care Consultation: A Multicenter Analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Predicting mortality in patients diagnosed with advanced dementia presenting at an acute care hospital: the PROgnostic Model for Advanced DEmentia (PRO-MADE). [2023]

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

Characteristics and Outcomes of Dementia Patients Who Receive Inpatient Palliative Care Consultation. [2021]

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

Effects of facilitated family case conferencing for advanced dementia: A cluster randomised clinical trial. [2018]

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

Hospice approach to the treatment of patients with advanced dementia of the Alzheimer type. [2016]

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

Prediction of 6-month mortality in nursing home residents with advanced dementia: validity of a risk score. [2007]