End-of-life Intervention for African American Dementia Caregivers

Community-based End-of-Life Intervention for African American Dementia Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Encephalopathy, Ischemic
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 355

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

"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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of dementia	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	Three years
Knowledge of cardiopulmonary resuscitation (CPR), mechanical ventilation (MV), tube feeding (TF)	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.	Three years
Self efficacy	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	Three years
Intention to make a Care Plan	Treatment Decisions Questionnaire measured Intention to make a Care Plan using the 3-item dichotomous (yes/no) items on each CPR, MV and TF.	Three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Written Care Plan	Treatment Decision Questionnaire 3 items dichotomous yes/no measuring actual care plan implemented on CPR, MV, TF	3 years

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Gloria J Bonner, PhD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2013
• Primary Completion (Actual): September 10, 2016
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: October 5, 2017
• First Submitted That Met QC Criteria: October 23, 2017
• First Posted (Actual): October 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 10, 2019
• Last Update Submitted That Met QC Criteria: December 8, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Brain Ischemia; Death; Dementia; Brain Diseases
• Other Study ID Numbers: 2013-0494; 5R01AG043485-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No