Advance Care Planning in Cognitive Disorders Clinic
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03864965|
Recruitment Status : Not yet recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advance Care Planning||Other: Advance Care Planning||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|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|
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.
- 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 ]
- 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).
- 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).
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
|Contact: Cristina Popescu, PhD||352 317 email@example.com|
|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|
|Principal Investigator:||Neal Weisbrod, MD||University of Florida|