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End-of-life Intervention for African American Dementia Caregivers

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ClinicalTrials.gov Identifier: NCT03323411
Recruitment Status : Completed
First Posted : October 27, 2017
Last Update Posted : December 10, 2019
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Gloria J. Bonner, University of Illinois at Chicago

Brief Summary:
In a community-based approach, the investigators long-term goal is to empower African American family caregivers who are designated healthcare proxies to make informed end-of-life treatment decisions for participants with moderate to severe dementia before a life-threatening medical crisis occurs.

Condition or disease Intervention/treatment
Encephalopathy, Ischemic Behavioral: Advance Care Treatment Plan

Detailed Description:
The investigators conducted a randomized controlled trial for efficacy of the Advance Care Treatment Program in an African American church-based community model. The investigators compared the effect of the experimental and control groups on knowledge, self-efficacy, intentions and behaviors from 4 urban African American churches randomly assigned to experimental (n=2) or control (n=2) conditions,304 (experimental n=152; control (n=152) health care proxies of participants that have advanced stage dementia: (a) were concurrently recruited in small classes each with 8-9 healthcare proxies.

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Study Type : Observational
Actual Enrollment : 355 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Community-based End-of-Life Intervention for African American Dementia Caregivers
Actual Study Start Date : August 15, 2013
Actual Primary Completion Date : September 10, 2016
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Intervention and attention control
the Advance Care Treatment Plan experimental group received education on dementia cardiopulmonary resuscitation and tube feeding. The attention control group received education on exercise stress control diabetes and hypertension
Behavioral: Advance Care Treatment Plan
subjects in experimental group are taught information on dementia mechanical ventilation tube feeding and cardiopulmonary resuscitation

Primary Outcome Measures :
  1. Knowledge of dementia [ Time Frame: Three years ]
    Knowledge of Dementia Scale measures Knowledge of dementia with 17 dichotomous true/false items, maximum total score = 17 and Cronbach's α=.76. Higher scores indicate greater practical understanding of dementia knowledge

  2. Knowledge of cardiopulmonary resuscitation (CPR), mechanical ventilation (MV), tube feeding (TF) [ Time Frame: Three years ]
    Knowledge of CPR, MV, and TF Scale mmeasures CPR, MV and TF with 18-items Likert (5-point) and yes/no questions. Higher scores indicate increased general knowledge of CPR, MV and TF.

  3. Self efficacy [ Time Frame: Three years ]
    Confidence in Treatment Decisions Made Scale measures self-efficacy on decision choices for CPR, MV, and TF with12-item Likert scale (1=extremely comfortable to 5=not at all comfortable) and Cronbach α=.93

  4. Intention to make a Care Plan [ Time Frame: Three years ]
    Treatment Decisions Questionnaire measured Intention to make a Care Plan using the 3-item dichotomous (yes/no) items on each CPR, MV and TF.

Secondary Outcome Measures :
  1. Written Care Plan [ Time Frame: 3 years ]
    Treatment Decision Questionnaire 3 items dichotomous yes/no measuring actual care plan implemented on CPR, MV, TF

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   301 african american females and 54 african american males
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
African American family caregivers over the age of 18 who attend four specific urban mega churches who meet the eligibility criteria for the study.

"Inclusion Criteria"

  • Caregiver spouse or adult child of care recipient
  • Caregiver knowledgeable about care recipient's medical history
  • Care recipient must be African American
  • Care recipient must have moderate to severe stage dementia
  • Care recipient must lack decisional capacity

"Exclusion Criteria"

  • Not a caregiver
  • Care recipient not African American,
  • Care recipient without moderate to severe dementia

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): NCT03323411

Sponsors and Collaborators
University of Illinois at Chicago
National Institute on Aging (NIA)
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Principal Investigator: Gloria J Bonner, PhD University of Illinois at Chicago
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Responsible Party: Gloria J. Bonner, Principal Investigator, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03323411    
Other Study ID Numbers: 2013-0494
5R01AG043485-05 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 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
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Pathologic Processes
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases