ClinicalTrials.gg
CompletedNCT03323411Updated Dec 10, 2019

End-of-life Intervention for African American Dementia Caregivers

An observational study in Encephalopathy, Ischemic, sponsored by University of Illinois at Chicago. Completed. Per ClinicalTrials.gov, last updated 2019-12-10.

Sponsored by University of Illinois at Chicago · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
355
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Encephalopathy, Ischemic

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In context

Brain Ischemia

217 studies on the registry are indexed under Brain Ischemia; 42 are open to participants now.

This study's enrollment of 355 is above the median of 203 across 72 observational studies indexed under Brain Ischemia.

Browse Brain Ischemia studies →

Lead sponsor

University of Illinois at Chicago is the lead sponsor of 506 studies on the registry; 120 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Eligibility 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
355 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • BehavioralAdvance Care Treatment Plan

    subjects in experimental group are taught information on dementia mechanical ventilation tube feeding and cardiopulmonary resuscitation

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Three years

  2. 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.

    Time frame: Three years

  3. 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

    Time frame: Three years

  4. 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.

    Time frame: Three years

Secondary outcomes

  1. Written Care Plan

    Treatment Decision Questionnaire 3 items dichotomous yes/no measuring actual care plan implemented on CPR, MV, TF

    Time frame: 3 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2013 to primary completion in Sep 2016, 36 months.

Of 34 non-industry observational studies under Brain Ischemia, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 121. This study's 36 months is below that.

Counting every sponsor, half of 36 studies reached it within 72 months; a quarter within 36 and three quarters within 121.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2017
First posted
Oct 27, 2017
StartActual
Aug 15, 2013
Primary completionActual
Sep 10, 2016
CompletionActual
May 31, 2019
Last update
Dec 10, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03323411
Responsible party
Gloria J. Bonner (Principal Investigator, University of Illinois at Chicago) — Principal investigator
First posted
Oct 27, 2017
Start date
Aug 15, 2013
Primary completion
Sep 10, 2016
Completion
May 31, 2019
Last update
Dec 10, 2019

Study contacts

Gloria J Bonner, PhD
principal investigator · University of Illinois at Chicago

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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