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Advance Care Planning in Cognitive Disorders Clinic

Primary Purpose

Advance Care Planning

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Advance Care Planning
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Advance Care Planning focused on measuring Alzheimer's disease, Dementia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Department of Neurology, College of Medicine, UF Health Medical Plaza
  • UF Health Fixel Center for Neurological Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Patients

Arm Description

Patients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will receive the guided advance care planning conversations with the PI

Patients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will not receive the guided advance care planning conversations with the PI

Outcomes

Primary Outcome Measures

Change in rate of advance directive completion during or following the visit
Change in the rate of completed advance directives that are uploaded to the patient's electronic medical record

Secondary Outcome Measures

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).
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).

Full Information

First Posted
March 5, 2019
Last Updated
September 20, 2022
Sponsor
University of Florida
Collaborators
Florida Department of Health
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1. Study Identification

Unique Protocol Identification Number
NCT03864965
Brief Title
Advance Care Planning in Cognitive Disorders Clinic
Official Title
Responses to a Standardized Approach to Advance Care Planning in Cognitive Disorders Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
June 9, 2022 (Actual)
Study Completion Date
June 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Florida Department of Health

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advance Care Planning
Keywords
Alzheimer's disease, Dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Patients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will receive the guided advance care planning conversations with the PI
Arm Title
Control Patients
Arm Type
No Intervention
Arm Description
Patients diagnosed with mild cognitive impairment, very mild dementia, or mild dementia, will not receive the guided advance care planning conversations with the PI
Intervention Type
Other
Intervention Name(s)
Advance Care Planning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in rate of advance directive completion during or following the visit
Time Frame
Baseline; Month 6; Month 12; Month 18
Title
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 Measure Information:
Title
Change in Hospital Anxiety and Depression Scale (HADS)
Description
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).
Time Frame
Baseline; Month 2; Month 3
Title
Change in Beck Hopelessness Scale (BHS)
Description
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).
Time Frame
Baseline; Month 2; Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Weisbrod, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, College of Medicine, UF Health Medical Plaza
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
UF Health Fixel Center for Neurological Diseases
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Advance Care Planning in Cognitive Disorders Clinic

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