End-of-life Intervention for African American Dementia Caregivers

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT03323411

Collaborator

National Institute on Aging (NIA) (NIH)

355

Enrollment

69.5

Actual Duration (Months)

Study Details

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	Phase
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 :

Aug 15, 2013

Actual Primary Completion Date :

Sep 10, 2016

Actual Study Completion Date :

May 31, 2019

Arms and Interventions

Arm	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

Arm

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

Knowledge of dementia [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
Knowledge of cardiopulmonary resuscitation (CPR), mechanical ventilation (MV), tube feeding (TF) [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.
Self efficacy [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
Intention to make a Care Plan [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

Written Care Plan [3 years]
Treatment Decision Questionnaire 3 items dichotomous yes/no measuring actual care plan implemented on CPR, MV, TF

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

"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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gloria J. Bonner, Principal Investigator, University of Illinois at Chicago

ClinicalTrials.gov Identifier:

NCT03323411

Other Study ID Numbers:

2013-0494
5R01AG043485-05

First Posted:

Oct 27, 2017

Last Update Posted:

Dec 10, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 10, 2019