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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the quality of life for older adults with dementia in nursing homes by testing a new method of providing Palliative Care through the UPLIFT-AD model. Palliative Care focuses on easing the symptoms and stress of serious illnesses to support both patients and their families. The trial trains nursing home staff in Palliative Care and offers consultations with specialists for complex cases. Individuals who have lived in a nursing home for over 30 days and have moderate to severe dementia may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative care approaches that could enhance the well-being of many.

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 prior data suggests that the UPLIFT-AD model is safe for residents with dementia?

Research shows that Palliative Care, including the UPLIFT-AD model, is generally well-tolerated by patients. It aims to improve quality of life and ease symptoms for people with serious illnesses, such as dementia.

In previous studies, patients receiving Palliative Care experienced increased comfort and support for both their physical and emotional needs. No major safety concerns or negative effects have been reported from Palliative Care itself, indicating it is a safe way to manage symptoms in older adults with dementia.

The UPLIFT-AD model specifically seeks to integrate both basic and specialized Palliative Care into nursing homes, providing extra support for patients and staff. This approach aligns with current Palliative Care practices, which are already widely accepted and used in many healthcare settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The UPLIFT-AD protocol is unique because it focuses on integrating comprehensive palliative care into nursing homes for residents with Alzheimer's Disease. This approach includes training in-house champions to facilitate important care planning conversations, which is not typically part of standard care. It also provides specialized palliative care consultations for complex needs, ensuring more tailored and compassionate support. Researchers are excited because this method could improve the quality of life for patients by addressing both medical and emotional needs more effectively than traditional nursing home care.

What evidence suggests that the UPLIFT-AD model is effective for Alzheimer's Disease?

Research has shown that adding palliative care in nursing homes can enhance the quality of life for people with dementia. This trial tests the UPLIFT-AD model, which combines basic and specialized palliative care as an intervention. This approach provides education and specific consultations to improve care. Early findings suggest these methods lead to better symptom control and increased comfort for patients. The UPLIFT-AD model addresses not only physical needs but also emotional and spiritual ones, improving overall well-being for patients and their families. Meanwhile, the usual care arm will continue with standard nursing home care practices. ^{2 3 4 6 7}

Who Is on the Research Team?

Kathleen T Unroe, MD, MHA

Principal Investigator

Indiana University

John Cagle, PhD, MSW

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37496001/

protocol of a palliative care clinical trial in nursing homes This trial assesses the implementation and effectiveness of a robust palliative care intervention for residents with moderate-to-advanced cognitive impairment ...

2. bmcpalliatcare.biomedcentral.com bmcpalliatcare.biomedcentral.com/articles/10.1186/s12904-023-01226-0

protocol of a palliative care clinical trial in nursing homes The study will 1) evaluate the effectiveness of the UPLIFT-AD implementation by comparing surrogate-reported symptom management and quality of ...

3. withpower.com withpower.com/trial/phase-alzheimer-disease-7-2021-687d6

UPLIFT-AD for Alzheimer's Disease Trial Overview The study tests UPLIFT-AD, a model integrating primary and specialty Palliative Care into nursing facilities for older adults with dementia.

4. iadrp.nia.nih.gov iadrp.nia.nih.gov/project/uplift-ad-utilizing-palliative-leaders-facilities-transform-care-alzheimers-disease

UPLIFT-AD (Utilizing Palliative Leaders in Facilities to ... - IADRP 1. Identifying, Assessing and Improving Care and Quality of Life for Persons with Dementia e. Palliative and End-of-Life Care

5. researchgate.net researchgate.net/publication/372654054_Using_Palliative_Leaders_in_Facilities_to_Transform_Care_for_People_with_Alzheimer's_Disease_UPLIFT-AD_protocol_of_a_palliative_care_clinical_trial_in_nursing_homes

protocol of a palliative care clinical trial in nursing homes Using Palliative Leaders in Facilities to Transform Care for People with Alzheimer's Disease (UPLIFT-AD): protocol of a palliative care clinical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10369841/

protocol of a palliative care clinical trial in nursing homes UPLIFT-AD is a pragmatic trial with a modified stepped wedge design, where the intervention is rolled out in four waves. Each wave includes four ...

7. research-studies.allinforhealth.info research-studies.allinforhealth.info/us/en/condition/312/dementia/?page=2

Dementia Clinical Research Studies | Indiana Studies The purpose of this study is to evaluate a comprehensive model for integrating both primary and specialty Palliative Care into nursing facilities. Learn ...