End-of-life Intervention for African American Dementia Caregivers

Encephalopathy, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03323411
• Other study ID #: 2013-0494
• Secondary ID: 5R01AG043485-05
• Status: Completed
• Start date: August 15, 2013
• Est. completion date: May 31, 2019

Study information

• Verified date: December 2019
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: May 31, 2019
• Est. primary completion date: September 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

"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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Dementia
• Encephalopathy, Ischemic

Intervention

Behavioral:
• Advance Care Treatment Plan
subjects in experimental group are taught information on dementia mechanical ventilation tube feeding and cardiopulmonary resuscitation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute on Aging (NIA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge of dementia	Knowledge of Dementia Scale measures Knowledge of dementia with 17 dichotomous true/false items, maximum total score = 17 and Cronbach's a=.76. Higher scores indicate greater practical understanding of dementia knowledge	Three years
Primary	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
Primary	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 a=.93	Three years
Primary	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	Written Care Plan	Treatment Decision Questionnaire 3 items dichotomous yes/no measuring actual care plan implemented on CPR, MV, TF	3 years