End-of-life Intervention for African American Dementia Caregivers

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

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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.

Criteria

"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

Contacts and Locations

Sponsors and Collaborators

University of Illinois at Chicago

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Gloria J Bonner, PhD; University of Illinois at Chicago

More Information

• 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
• Last Update Posted: December 10, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Dementia; Brain Diseases; Brain Ischemia; Death; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases