Alzheimer DiseasePCEAL-DCPNCT06722352
Palliative Care Education in Assisted Living for Dementia Care Providers (PCEAL-DCP)
A study testing Palliative Care Training in people with Alzheimer Disease and End of Life, run by University of South Florida at 2 sites in United States.
Trial summary
The palliative care education in assisted living for dementia care providers (PCEAL-DCP) is a 4-week intervention (once a week for 1.5 hours, a total of 6 hours) for licensed nurses, administrators and dementia care coordinators to improve quality of dementia care outcomes Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, End of Life, Caregiver Burden
- What is being tested?
- Palliative Care Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 792 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jan 2025to 1 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The AL community eligibility criteria include a minimum of 40+ beds and provide memory care services to at least 35% of their residents, and access to hospice services from Lifepath or Suncoast Hospice. The AL size of 40+ beds is selected so we will be able to recruit a minimum of 14 residents per site, based on the power analysis for the sample size of 450 for the primary study outcome of documentation of ACP discussions.
- Residents are eligible if 1) they have a dementia diagnosis confirmed by the resident's physician (physician's signature required by University of South Florida (USF) Institutional Reiew Board (IRB) in prior clinical trial) regardless of dementia severity (mild, moderate, or severe), 2) if they have been admitted to the AL in the last month, and 3) if they have a legally responsible representative who understands English.
- Staff are eligible if they are currently employed with the participating study AL as a registered/licensed practical nurse, administrator, or dementia care coordinator of a memory care unit and English speaking and 21 years of age or older.
- Family members are eligible if 1) they are listed as the legally responsible party in the chart records for the resident with ADRD, 2) they understand English, and 3) are at least 21 years of age or older. This could include someone related to the person, a close friend or a legal guardian who oversees the person's care and is responsible for decisions about their care.
Who cannot join
- AL sites will be ineligible if 1) the are not a licensed Florida assisted living facility; 2) they have previously participated in a PCEAL-DCP clinical trial (2018-2021) to avoid possible experimental contamination effects, and 3) if no staff employed at the AL are willing to participate in the study.
- Residents are ineligible if they: 1) are currently receiving hospice services because residents who receive hospice are already engaged in ACP discussions upon admission; 2) if they are discharged from assisted living to another setting (nursing home or hospital) or are admitted to hospice or have died before baseline data is collected.
- Staff will be ineligible if they are not licensed nurses, administrators or dementia care coordinators of a dementia care unit or terminated/resign before baseline data is collected.
- Family are ineligible if: 1) they are under 21 years of age and do not understand spoken or written English and if there is already a legal authorized representative for a resident participating in the study (one family member per resident).
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33612
Debra Dobbs, PhD, ddobbs@usf.edu
- Recruiting
University of South Florida
Tampa, Florida, 33620
Debra Dobbs, PhD., 813-974-5767, ddobbs@usf.edu
Jonathan Clapp, PhD, jdc2@usf.edu
About this study
Official title: Preparing Assisted Living Staff to Provider Palliative Care to Residents With Dementia: Palliative Care Education in Assisted Living for Dementia Care Providers (PCEAL-DCP)
The palliative care education in assisted living for dementia care providers (PCEAL-DCP) is a 4-week intervention (once a week for 1.5 hours, a total of 6 hours) for licensed nurses, administrators and dementia care coordinators to improve quality of dementia care outcomes
Read the detailed description
This is a five-year cluster randomized trial (CRT) among 30 assisted living (AL) communities (k=30) and residents (N=450), staff (N=72) and family members (N=270) with a baseline, 3, and 6 months post-intervention follow-ups for residents, a baseline and 6-month follow-up for family and a pre- and post-test (one month), 3- and 6-month follow-up for staff and baseline AL facility information from administrators to examine dementia care outcomes.
- Conditions
- Alzheimer Disease, End of Life, Caregiver Burden, Caregiver Burnout, Patient Participation, Self Efficacy
- Being tested
- Palliative Care Training
- Keywords
- end of life, palliative care, education, staff training, assisted living, dementia, dementia care, Alzheimer's
- Medical subject headings
- Alzheimer Disease, Death, Caregiver Burden, Patient Participation, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative Care TrainingBehavioural
Teaching about caring for individuals with
| Study group | Role | What they receive |
|---|---|---|
| Intervention - | Experimental | Hospice nurses or social workers selected from LifePath and Suncoast Hospice organizations will train the AL interventionists on the PCEAL-DCP intervention. All hospice nurses and social workers who are facilitators will be licensed practical nurses, registered nurses or master's in social work. Prior to the intervention, the hospice facilitators will complete a four-hour workshop about the topics to cover and be trained on the protocol to follow for facilitation of the four-week PCEAL sessions so each cluster in the treatment group is trained in the same manner. Receives: Behavioral: Palliative Care Training |
| Control | No intervention | Wait-listed group will receive the PCEAL-DCP curriculum after completion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of Advance Care Planning (ACP) Discussions
Resident Chart: Percent of residents in sample with documentation in chart of any discussion of ACP with residents or family, last 90 days.
Resident Chart: Percent of residents in sample with living will, health care surrogate, durable power of attorney and do not resuscitate (DNR)s in chart. (yes/no).
Measured: Baseline, 3, and 6 months
Secondary outcomes (1)
Hospice Use
Hospice use (Secondary Outcome) Resident Chart: Percent of residents in sample admitted to hospice: Calculated based on # of residents admitted to hospice in last three months. Resident Resident Resident
Hospice use (Secondary Outcome) Resident Chart: Percent of residents in sample admitted to hospice: Calculated based on # of residents admitted to hospice in last three months. Resident Resident Resident Percent of residents in sample admitted to hospice: Calculated based on # of residents admitted to hospice in last three months.
Measured: Baseline, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start28 Jan 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 University of South FloridaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 792 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Debra Dobbs, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722352
- Sponsor's protocol ID
- 007811
- Other IDs
- 1RF1AG087325-01
- Acronym
- PCEAL-DCP
- Status last verified
- Apr 2026
- First submitted
- 3 Dec 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dobbs D, Yauk J, Vogel CE, Fanfan D, Buck H, Haley WE, Meng H. Feasibility of the Palliative Care Education in Assisted Living Intervention for Dementia Care Providers: A Cluster Randomized Trial. Gerontologist. 2024 Jan 1;64(1):gnad018. doi: 10.1093/geront/gnad018.
PubMed 36842068Bureau Y, Rodat G, Barriere H, Litoux P, Bureau B. [Cutaneous mastocytosis in adults with hepatic mastocytosis and blood monocytosis]. Bull Soc Fr Dermatol Syphiligr. 1965 Nov-Dec;72(6):850-3. No abstract available. French.
PubMed 5881970
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing Assisted Living Staff to Provider Palliative Care to Residents With Dementia: Palliative Care Education in Assisted Living for Dementia Care Providers (PCEAL-DCP)
- ClinicalTrials.gov ID
- NCT06722352
- Acronym / sponsor ID
- PCEAL-DCP / 007811
- Conditions
- Alzheimer Disease, End of Life, Caregiver Burden, Caregiver Burnout, Patient Participation, Self Efficacy
- Keywords
- end of life, palliative care, education, staff training, assisted living, dementia, dementia care, Alzheimer's
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 792 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 9 Dec 2024 (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 palliative care education in assisted living for dementia care providers (PCEAL-DCP) is a 4-week intervention (once a week for 1.5 hours, a total of 6 hours) for licensed nurses, administrators and dementia care coordinators to improve quality of dementia care outcomes
Detailed description
This is a five-year cluster randomized trial (CRT) among 30 assisted living (AL) communities (k=30) and residents (N=450), staff (N=72) and family members (N=270) with a baseline, 3, and 6 months post-intervention follow-ups for residents, a baseline and 6-month follow-up for family and a pre- and post-test (one month), 3- and 6-month follow-up for staff and baseline AL facility information from administrators to examine dementia care outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - | Experimental | Behavioral: Palliative Care TrainingHospice nurses or social workers selected from LifePath and Suncoast Hospice organizations will train the AL interventionists on the PCEAL-DCP intervention. All hospice nurses and social workers who are facilitators will be licensed practical nurses, registered nurses or master's in social work. Prior to the intervention, the hospice facilitators will complete a four-hour workshop about the topics to cover and be trained on the protocol to follow for facilitation of the four-week PCEAL sessions so each cluster in the treatment group is trained in the same manner. |
| Control | No intervention | –Wait-listed group will receive the PCEAL-DCP curriculum after completion of the study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The AL community eligibility criteria include a minimum of 40+ beds and provide memory care services to at least 35% of their residents, and access to hospice services from Lifepath or Suncoast Hospice. The AL size of 40+ beds is selected so we will be able to recruit a minimum of 14 residents per site, based on the power analysis for the sample size of 450 for the primary study outcome of documentation of ACP discussions.
- Residents are eligible if 1) they have a dementia diagnosis confirmed by the resident's physician (physician's signature required by University of South Florida (USF) Institutional Reiew Board (IRB) in prior clinical trial) regardless of dementia severity (mild, moderate, or severe), 2) if they have been admitted to the AL in the last month, and 3) if they have a legally responsible representative who understands English.
- Staff are eligible if they are currently employed with the participating study AL as a registered/licensed practical nurse, administrator, or dementia care coordinator of a memory care unit and English speaking and 21 years of age or older.
- Family members are eligible if 1) they are listed as the legally responsible party in the chart records for the resident with ADRD, 2) they understand English, and 3) are at least 21 years of age or older. This could include someone related to the person, a close friend or a legal guardian who oversees the person's care and is responsible for decisions about their care.
Key exclusion criteria (5 listed)
- AL sites will be ineligible if 1) the are not a licensed Florida assisted living facility; 2) they have previously participated in a PCEAL-DCP clinical trial (2018-2021) to avoid possible experimental contamination effects, and 3) if no staff employed at the AL are willing to participate in the study.
- Residents are ineligible if they: 1) are currently receiving hospice services because residents who receive hospice are already engaged in ACP discussions upon admission; 2) if they are discharged from assisted living to another setting (nursing home or hospital) or are admitted to hospice or have died before baseline data is collected.
- Staff will be ineligible if they are not licensed nurses, administrators or dementia care coordinators of a dementia care unit or terminated/resign before baseline data is collected.
- Family are ineligible if: 1) they are under 21 years of age and do not understand spoken or written English and if there is already a legal authorized representative for a resident participating in the study (one family member per resident).
- -
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 |
|---|---|---|
| Palliative Care TrainingTeaching about caring for individuals with | Behavioural | Intervention - |
Primary outcome
Documentation of Advance Care Planning (ACP) Discussions
Time frame: Baseline, 3, and 6 months
Resident Chart: Percent of residents in sample with documentation in chart of any discussion of ACP with residents or family, last 90 days. Resident Chart: Percent of residents in sample with living will, health care surrogate, durable power of attorney and do not resuscitate (DNR)s in chart. (yes/no).
1 secondary outcome
Hospice Use
Time frame: Baseline, 3, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 36842068Dobbs D, Yauk J, Vogel CE, Fanfan D, Buck H, Haley WE, Meng H. Feasibility of the Palliative Care Education in Assisted Living Intervention for Dementia Care Providers: A Cluster Randomized Trial. Gerontologist. 2024 Jan 1;64(1):gnad018. doi: 10.1093/geront/gnad018.
- Background: PubMed 5881970Bureau Y, Rodat G, Barriere H, Litoux P, Bureau B. [Cutaneous mastocytosis in adults with hepatic mastocytosis and blood monocytosis]. Bull Soc Fr Dermatol Syphiligr. 1965 Nov-Dec;72(6):850-3. No abstract available. French.
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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.
Debra Dobbs, PhD principal investigator
University of South Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Care Training in people with Alzheimer Disease and End of Life, run by University of South Florida at 2 sites 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debra Dobbs, PhD (813-974-5767, ddobbs@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documentation of Advance Care Planning (ACP) Discussions (time frame: Baseline, 3, and 6 months). 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 NCT06722352, which also lists 2 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 Apr 2026.