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Advance Care Planning in Cognitive Disorders Clinic

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ClinicalTrials.gov Identifier: NCT03864965
Recruitment Status : Not yet recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
Florida Department of Health
Information provided by (Responsible Party):
University of Florida

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Advance Care Planning Other: Advance Care Planning Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Responses to a Standardized Approach to Advance Care Planning in Cognitive Disorders Clinic
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: Intervention Group
Patients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will receive the guided advance care planning conversations with the PI during the third visit.
Other: Advance Care Planning
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.

No Intervention: Control Patients
Patients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will not receive the guided advance care planning conversations with the PI during the third visit.



Primary Outcome Measures :
  1. Change in rate of advance directive completion during or following the visit [ Time Frame: Baseline; Month 6; Month 12; Month 18 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline; Month 2; Month 3 ]
    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).

  2. Change in Beck Hopelessness Scale (BHS) [ Time Frame: Baseline; Month 2; Month 3 ]
    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).



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients having mild cognitive impairment (MCI) or very mild to mild dementia (CDR 0.5-1).

Exclusion Criteria:

  • Patients with moderate to severe dementia (CDR 2-3).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864965


Contacts
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Contact: Cristina Popescu, PhD 352 317 6920 cristina.popescu@ufl.edu

Locations
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United States, Florida
Department of Neurology, College of Medicine, UF Health Medical Plaza Not yet recruiting
Gainesville, Florida, United States, 32610
UF Health Fixel Center for Neurological Diseases Not yet recruiting
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Florida Department of Health
Investigators
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Principal Investigator: Neal Weisbrod, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03864965     History of Changes
Other Study ID Numbers: IRB201900108
ID00023545 ( Other Grant/Funding Number: FL DOH )
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Alzheimer's disease
Dementia

Additional relevant MeSH terms:
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Cognition Disorders
Neurocognitive Disorders
Mental Disorders