Advance Care PlanningNCT03864965
Advance Care Planning in Cognitive Disorders Clinic
A study testing Advance Care Planning in people with Advance Care Planning, run by University of Florida at 2 sites in United States.
Trial summary
Advance care planning among patients with cognitive disorders poses unique challenges to clinicians. To improve planning in patients with Alzheimer's disease and other dementias, the researchers suggest a routine, standardized approach to these conversations. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Advance Care Planning
- What is being tested?
- Advance Care Planning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2019to 9 Jun 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having mild cognitive impairment (MCI) or very mild to mild dementia (CDR 0.5-1).
Who cannot join
- Patients with moderate to severe dementia (CDR 2-3).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Neurology, College of Medicine, UF Health Medical Plaza
Gainesville, Florida, 32610
UF Health Fixel Center for Neurological Diseases
Gainesville, Florida, 32611
About this study
Official title: Responses to a Standardized Approach to Advance Care Planning in Cognitive Disorders Clinic
Advance care planning among patients with cognitive disorders poses unique challenges to clinicians. To improve planning in patients with Alzheimer's disease and other dementias, the researchers suggest a routine, standardized approach to these conversations. The main outcome measure is the rate of entry of Advance Directive completion in the patient's Electronic Health Record (EHR). A control group of similar patients from another provider specializing in cognitive disorders will be used to tease out confounding variable effects.
- Conditions
- Advance Care Planning
- Being tested
- Advance Care Planning
- Keywords
- Alzheimer's disease, Dementia
- 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.
Advance Care PlanningOther
The provider will guide advance care planning conversations with patients identified with mild or moderate dementia during their third office visit, approximately three months after the first visit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will receive the guided advance care planning conversations with the PI Receives: Other: Advance Care Planning |
| Control Patients | No intervention | Patients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will not receive the guided advance care planning conversations with the PI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rate of advance directive completion during or following the visit
Measured: Baseline; Month 6; Month 12; Month 18
Change in the rate of completed advance directives that are uploaded to the patient's electronic medical record
Measured: Baseline; Month 6; Month 12; Month 18
Secondary outcomes (2)
Change in Hospital Anxiety and Depression Scale (HADS)
Scale consisting of 14 items (7 relating to anxiety; 7 to depression). Scores range from 0-21 (0-7 being normal; 08-10 being borderline abnormal; 11-21 being abnormal for anxiety and depression).
Measured: Baseline; Month 2; Month 3
Change in Beck Hopelessness Scale (BHS)
Scale consisting of 20 true-false items arrayed within three factors: Feelings about the future, loss of motivation, and future expectations. Scores range from 0-20 (0-3 as are considered within the normal range, 4-8 identify mild hopelessness, scores from 9-14 identify moderate hopelessness, and scores greater than 14 identify severe hopelessness).
Measured: Baseline; Month 2; Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start1 Jul 2019
- Primary completion9 Jun 2022
- Study completion9 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by University of 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health
- Responsible party
- Sponsor
- Investigators
- Neal Weisbrod, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864965
- Sponsor's protocol ID
- IRB201900108
- Other IDs
- ID00023545, OCR21061
- Status last verified
- Sep 2022
- First submitted
- 5 Mar 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responses to a Standardized Approach to Advance Care Planning in Cognitive Disorders Clinic
- ClinicalTrials.gov ID
- NCT03864965
- Acronym / sponsor ID
- IRB201900108
- Conditions
- Advance Care Planning
- Keywords
- Alzheimer's disease, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Florida Department of Health
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 9 Jun 2022 (actual)
- Study completion
- 9 Jun 2022 (actual)
- First posted
- 6 Mar 2019 (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.
Advance care planning among patients with cognitive disorders poses unique challenges to clinicians. To improve planning in patients with Alzheimer's disease and other dementias, the researchers suggest a routine, standardized approach to these conversations. The main outcome measure is the rate of entry of Advance Directive completion in the patient's Electronic Health Record (EHR). A control group of similar patients from another provider specializing in cognitive disorders will be used to tease out confounding variable effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Advance Care PlanningPatients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will receive the guided advance care planning conversations with the PI |
| Control Patients | No intervention | –Patients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will not receive the guided advance care planning conversations with the PI |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having mild cognitive impairment (MCI) or very mild to mild dementia (CDR 0.5-1).
Key exclusion criteria (1 listed)
- Patients with moderate to severe dementia (CDR 2-3).
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 |
|---|---|---|
| Advance Care PlanningThe provider will guide advance care planning conversations with patients identified with mild or moderate dementia during their third office visit, approximately three months after the first visit. | Other | Intervention Group |
Primary outcome
Change in rate of advance directive completion during or following the visit
Time frame: Baseline; Month 6; Month 12; Month 18
Change in the rate of completed advance directives that are uploaded to the patient's electronic medical record
Time frame: Baseline; Month 6; Month 12; Month 18
2 secondary outcomes
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline; Month 2; Month 3
Change in Beck Hopelessness Scale (BHS)
Time frame: Baseline; Month 2; Month 3
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 21 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Neal Weisbrod, MD principal investigator
University of 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 Advance Care Planning in people with Advance Care Planning, run by University of 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 1 inclusion and 1 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 21 Sep 2022. 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?
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 rate of advance directive completion during or following the visit (time frame: Baseline; Month 6; Month 12; Month 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.