Alzheimer DiseaseUPLIFT-ADNCT04520698
Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease
A study testing UPLIFT-AD in people with Alzheimer Disease, run by Indiana University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- UPLIFT-AD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,322 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- NURSING HOME RESIDENTS:
- Long-stay resident in an enrolled nursing home defined as not paying through Medicare Part A at the enrolled facility.
- Has a diagnosis of moderate to severe ADRD, as measured on the Minimum Data Set (MDS)
- Length of stay >30 days
- FAMILY MEMBERS/SURROGATE DECISION MAKERS:
Show all 11Show fewer
- Family member and/or surrogate decision maker for an eligible resident in an enrolled nursing home
- English-speaking
- NURSING HOME STAFF:
- Staff, nurse, or nurse assistant in an enrolled nursing facility
- English-speaking
Who cannot join
- -
- NURSING HOME RESIDENTS:
- Short-stay resident, defined as paying through Medicare Part A at the enrolled facility and/or receiving respite care
- FAMILY MEMBERS/SURROGATE DECISION MAKERS:
- Non-English-speaking
- NURSING FACILITY STAFF:
- Non-English-speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
American Senior Communities
Indianapolis, Indiana, 46201
About this study
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.
Read the detailed description
The objective of this proposal is to evaluate the effectiveness of the UPLIFT-AD (Utilizing Palliative Leaders In Facilities to Transform care for Alzheimer's Disease) intervention and to assess the implementation context of the intervention using a hybrid 1 trial design. The UPLIFT-AD intervention includes 1) in-house PC champions trained to facilitate goals of care conversations with residents with Alzheimer's Disease and Related Dementias (ADRD) and their surrogate decision-makers, screen residents for symptoms and other PC needs, provide symptom management and serve as a liaison to external PC consultants; 2) specialty PC consultants who provide consults for complex residents and families; and 3) primary PC education for nursing home (NH) staff. The study will use a randomized, stepped wedge design involving 16 diverse NHs in Indiana and Maryland and 640 residents, 640 family members and/or surrogate decision-makers, and 320 nursing facility staff.
- Conditions
- Alzheimer Disease
- Being tested
- UPLIFT-AD
- Keywords
- Alzheimer Disease, Palliative Care, Dementia, Nursing Home
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPLIFT-ADBehavioural
Access to palliative care needs screening, advance care planning conversations, palliative care consultations
| Study group | Role | What they receive |
|---|---|---|
| Nursing Home-level UPLIFT-AD intervention | Experimental | 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. Receives: Behavioral: UPLIFT-AD |
| Usual Care | No intervention | Usual nursing home care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in End-of-Life Dementia - Comfort Assessment In Dying scale (EOLD-CAD)
Nursing home staff and family members reported symptom frequency and intensity for 18 symptoms in the past 30 days. Symptom assessment was derived from the End-of-Life in Dementia Comfort Assessment in Dying (EOLD-CAD) and End-of-Life in Dementia Symptom Management (EOLD-SM) instruments. These symptoms included pain, discomfort, shortness of breath, choking, gurgling, difficulty swallowing, skin breakdown, restlessness, agitation, anxiety, depression, fear, crying, moaning, resistiveness to care, calm, serenity, peace. If the symptom did occur, respondents were asked if it had occurred once a month, 2-3 days a month, once a week, several days a week, or every day (ranging 0-5) and asked if the symptom was not at all intense, somewhat intense or very intense (ranging 1-3). Frequency and intensity were multiplied together for a score of 0-15 per symptom. A total score was derived by calculating the sum score and dividing by number of items. Higher scores indicate greater symptom burden.
Measured: Baseline (prior to intervention) and12 months (post intervention implementation)
Secondary outcomes (5)
Change in End of Life Dementia - Satisfaction with Care (EOLD-SWC) scale
The outcome measure is change in the EOLD-SWC scale score. Participating family members/surrogate decisionmakers provided answers to questions asked over a 30 day timeframe. There are 10 items, each measured on a 4-point Likert scale ranging from 1 to 4 as follows: strongly disagree, disagree, agree, strongly agree. The items are added together for a cumulative score for a range of 10-40, with higher scores indicating greater satisfaction with care. The questionnaire items address decision-making, communication with health care professionals, understanding the resident's condition, and the resident's medical and nursing care.
Measured: Baseline (prior to intervention) and 12 months (post intervention implementation)
Change in Quality-of-life (QOL)
The outcome measure is change in the quality-of-life (QOL) measure scale score. Two quality-of-life questions were asked of nursing home staff and family/surrogate decisionmakers about the respective resident's quality of life. One quality-of-life measure is a seven point scale describing overall quality of life. Another is a five point scale describing quality of life. Lower scores indicate poorer quality of life.
Measured: Baseline (prior to intervention) and 12 months (post intervention implementation)
Change in staff palliative care knowledge
Change in staff palliative care knowledge will be measured by the Palliative Care survey (PCS). The PCS is a validated instrument, which includes subscales evaluating the frequency of key PC practice behaviors: family communication, provider coordination, planning/intervention, and bereavement. The total instrument score and each of the subscales are averaged to produce a range from 1 to 4, with higher scores indicating superior PC practices.
Measured: Baseline and 6 months (post intervention implementation)
Quality of Dying in Long-Term Care (QOD-LTC)
The quality of dying-long-term care (QOD-LTC) scale was developed for cognitively impaired and intact residents. It was developed to be reported post-death for residents in NHs and residential care/assisted living settings. It assesses perspectives on quality of personhood, closure, and preparatory tasks. Higher mean scores reflect a higher quality of end-of-life in LTC. This was collected from nursing home staff and family/surrogate decisionmakers.
Measured: Collected post-death
Change in Family Distress in Advanced Dementia Scale (Modified)
The Family Distress in Advanced Dementia Scale was developed for use with family members of nursing home residents with advanced dementia. Eighteen items from the scale were asked, consisting of three domains of distress: emotional distress, dementia preparedness, and nursing home relations . Higher scores indicate higher distress. Collected from family/surrogate decisionmakers only.
Measured: Baseline (prior to intervention) and 12 months (post intervention implementation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start8 Sep 2021
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- The study will use a stepped-wedge non-randomized trial design with 16 sites in two states (Indiana and Maryland). The study team will compare process and outcomes of the UPLIFT-AD intervention vs. usual care. The intervention will be implemented consecutively over 36 months, with staggered roll-out at 4 sites (2 per state) approximately every 6 months.
- Masking
- None (open label)
- Enrolment
- 1,322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kathleen T. Unroe, Indiana University
- Investigators
- Kathleen T Unroe, MD, MHA, Principal investigator, Indiana UniversityJohn Cagle, PhD, MSW, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520698
- Sponsor's protocol ID
- 2005967061
- Other IDs
- R01AG066922
- Acronym
- UPLIFT-AD
- Status last verified
- Jul 2026
- First submitted
- 17 Aug 2020
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified dataset will be created for the purposes of sharing with qualified users, along with data content, format, and organization, will be stored at Indiana University and be available through the Co-PIs. Deidentified data will be available to qualified users who execute Data Use Agreements (DUAs) with the research team and NH partners.
Publications
Tucker GG, Cagle JG, Stump TE, Tu W, Becker TD, Floyd A, Zhang P, Unroe KT. Family Visits and Symptom Burden in Nursing Home Residents With Cognitive Impairment. J Am Geriatr Soc. 2026 Jul 15. doi: 10.1111/jgs.70552. Online ahead of print.
PubMed 42455515Boakye A, Cagle J, Tucker G, Ersek M, Floyd AC, Elftmann H, Zhang P, Unroe KT. Family perceptions of palliative care consultations for nursing home residents. BMC Palliat Care. 2026 Apr 16;25(1):152. doi: 10.1186/s12904-026-02093-1.
PubMed 41987115Unroe KT, Ersek M, Stump TE, Floyd A, Nesvet M, Block LVD, Tu W, Cagle JG. Discordance in Ratings of Symptoms Experienced by Nursing Home Residents With Cognitive Impairment. J Pain Symptom Manage. 2026 Mar;71(3):403-410.e4. doi: 10.1016/j.jpainsymman.2025.11.022. Epub 2025 Nov 28.
PubMed 41319818Cagle JG, Stump TE, Tu W, Ersek M, Floyd A, Van den Block L, Zhang P, Becker TD, Unroe KT. A Psychometric Evaluation of the Staff-Reported EOLD-CAD Measure Among Nursing Home Residents With Cognitive Impairment. Int J Geriatr Psychiatry. 2025 Jan;40(1):e70037. doi: 10.1002/gps.70037.
PubMed 39743326Unroe KT, Ersek M, Tu W, Floyd A, Becker T, Trimmer J, Lamie J, Cagle J. 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. BMC Palliat Care. 2023 Jul 26;22(1):105. doi: 10.1186/s12904-023-01226-0.
PubMed 37496001
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04520698
- Acronym / sponsor ID
- UPLIFT-AD / 2005967061
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, Palliative Care, Dementia, Nursing Home
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,322 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore, National Institute on Aging (NIA)
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 20 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this proposal is to evaluate the effectiveness of the UPLIFT-AD (Utilizing Palliative Leaders In Facilities to Transform care for Alzheimer's Disease) intervention and to assess the implementation context of the intervention using a hybrid 1 trial design. The UPLIFT-AD intervention includes 1) in-house PC champions trained to facilitate goals of care conversations with residents with Alzheimer's Disease and Related Dementias (ADRD) and their surrogate decision-makers, screen residents for symptoms and other PC needs, provide symptom management and serve as a liaison to external PC consultants; 2) specialty PC consultants who provide consults for complex residents and families; and 3) primary PC education for nursing home (NH) staff. The study will use a randomized, stepped wedge design involving 16 diverse NHs in Indiana and Maryland and 640 residents, 640 family members and/or surrogate decision-makers, and 320 nursing facility staff.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will use a stepped-wedge non-randomized trial design with 16 sites in two states (Indiana and Maryland). The study team will compare process and outcomes of the UPLIFT-AD intervention vs. usual care. The intervention will be implemented consecutively over 36 months, with staggered roll-out at 4 sites (2 per state) approximately every 6 months.
| Arm | Type | Receives |
|---|---|---|
| Nursing Home-level UPLIFT-AD intervention | Experimental | Behavioral: UPLIFT-ADThe 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. |
| Usual Care | No intervention | –Usual nursing home care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- -
- Long-stay resident in an enrolled nursing home defined as not paying through Medicare Part A at the enrolled facility.
- Has a diagnosis of moderate to severe ADRD, as measured on the Minimum Data Set (MDS)
- Length of stay >30 days
- Family member and/or surrogate decision maker for an eligible resident in an enrolled nursing home
Key exclusion criteria (7 listed)
- -
- Short-stay resident, defined as paying through Medicare Part A at the enrolled facility and/or receiving respite care
- Non-English-speaking
- Non-English-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UPLIFT-ADAccess to palliative care needs screening, advance care planning conversations, palliative care consultations | Behavioural | Nursing Home-level UPLIFT-AD intervention |
Primary outcome
Change in End-of-Life Dementia - Comfort Assessment In Dying scale (EOLD-CAD)
Time frame: Baseline (prior to intervention) and12 months (post intervention implementation)
Nursing home staff and family members reported symptom frequency and intensity for 18 symptoms in the past 30 days. Symptom assessment was derived from the End-of-Life in Dementia Comfort Assessment in Dying (EOLD-CAD) and End-of-Life in Dementia Symptom Management (EOLD-SM) instruments. These symptoms included pain, discomfort, shortness of breath, choking, gurgling, difficulty swallowing, skin breakdown, restlessness, agitation, anxiety, depression, fear, crying, moaning, resistiveness to care, calm, serenity, peace. If the symptom did occur, respondents were asked if it had occurred once a month, 2-3 days a month, once a week, several days a week, or every day (ranging 0-5) and asked if the symptom was not at all intense, somewhat intense or very intense (ranging 1-3). Frequency and intensity were multiplied together for a score of 0-15 per symptom. A total score was derived by calculating the sum score and dividing by number of items. Higher scores indicate greater symptom burden.
5 secondary outcomes
Change in End of Life Dementia - Satisfaction with Care (EOLD-SWC) scale
Time frame: Baseline (prior to intervention) and 12 months (post intervention implementation)
Change in Quality-of-life (QOL)
Time frame: Baseline (prior to intervention) and 12 months (post intervention implementation)
Change in staff palliative care knowledge
Time frame: Baseline and 6 months (post intervention implementation)
Quality of Dying in Long-Term Care (QOD-LTC)
Time frame: Collected post-death
Change in Family Distress in Advanced Dementia Scale (Modified)
Time frame: Baseline (prior to intervention) and 12 months (post intervention implementation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Derived from this study: PubMed 42455515Tucker GG, Cagle JG, Stump TE, Tu W, Becker TD, Floyd A, Zhang P, Unroe KT. Family Visits and Symptom Burden in Nursing Home Residents With Cognitive Impairment. J Am Geriatr Soc. 2026 Jul 15. doi: 10.1111/jgs.70552. Online ahead of print.
- Derived from this study: PubMed 41987115Boakye A, Cagle J, Tucker G, Ersek M, Floyd AC, Elftmann H, Zhang P, Unroe KT. Family perceptions of palliative care consultations for nursing home residents. BMC Palliat Care. 2026 Apr 16;25(1):152. doi: 10.1186/s12904-026-02093-1.
- Derived from this study: PubMed 41319818Unroe KT, Ersek M, Stump TE, Floyd A, Nesvet M, Block LVD, Tu W, Cagle JG. Discordance in Ratings of Symptoms Experienced by Nursing Home Residents With Cognitive Impairment. J Pain Symptom Manage. 2026 Mar;71(3):403-410.e4. doi: 10.1016/j.jpainsymman.2025.11.022. Epub 2025 Nov 28.
- Derived from this study: PubMed 39743326Cagle JG, Stump TE, Tu W, Ersek M, Floyd A, Van den Block L, Zhang P, Becker TD, Unroe KT. A Psychometric Evaluation of the Staff-Reported EOLD-CAD Measure Among Nursing Home Residents With Cognitive Impairment. Int J Geriatr Psychiatry. 2025 Jan;40(1):e70037. doi: 10.1002/gps.70037.
- Derived from this study: PubMed 37496001Unroe KT, Ersek M, Tu W, Floyd A, Becker T, Trimmer J, Lamie J, Cagle J. 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. BMC Palliat Care. 2023 Jul 26;22(1):105. doi: 10.1186/s12904-023-01226-0.
- Individual participant dataSharing planned: Yes. A de-identified dataset will be created for the purposes of sharing with qualified users, along with data content, format, and organization, will be stored at Indiana University and be available through the Co-PIs. Deidentified data will be available to qualified users who execute Data Use Agreements (DUAs) with the research team and NH partners.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen T Unroe, MD, MHA principal investigator
Indiana University
John Cagle, PhD, MSW principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UPLIFT-AD in people with Alzheimer Disease, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in End-of-Life Dementia - Comfort Assessment In Dying scale (EOLD-CAD) (time frame: Baseline (prior to intervention) and12 months (post intervention implementation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04520698, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.