Caregiver Outcomes of Alzheimer's Disease Screening



Status:Recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:65 - Any
Updated:10/27/2018
Start Date:October 15, 2018
End Date:September 30, 2023
Contact:Lev Inger, MPH
Email:levinger@iupui.edu
Phone:317-274-9123

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This study will measure the risks and benefits of early screening of Alzheimer's disease.
Early diagnosis through screening may enhance the family member's transition to a family
caregiver and reduce caregiver burden by providing an opportunity for the family member to
learn about the syndrome, receive interventions, and to prepare for their new care giving
role.

We are proposing the first randomized controlled trial (RCT) to evaluate the benefits and
harms of AD screening on family members of older adults. The proposed trial will randomize
1,800 dyads (older adult and family member) into three groups. Older adults in the first
group will be screened for AD at baseline coupled with disclosure of the screening results to
the dyad and to the patient's primary care provider (Screening Only Group). Older adults in
the second group will be screened for AD at baseline coupled with disclosure of the screening
results and, if they screen positive, referred to the Aging Brain Care (ABC) Program for
diagnostic evaluation and care, if AD is diagnosed (Screening Plus Group). Older adults in
the third group will not be screened at baseline and will observed through surveillance of
the patients' EHR for any screening or incident AD diagnoses that occurs as part of routine
care. At the last follow-up assessment (24 months) we will we will screen the older adults
and conduct an interview with the family caregiver to detect possible cognitive impairment
(Control Group).

Specific Aim 1: Evaluate the impact of AD screening on family members' quality of life.

Hypothesis 1: In comparison to the control group, family members randomized to the screening
only or the screening plus groups will express higher levels of health-related quality of
life at 24 months as measured by the Short Form Health Survey (SF-36).

Specific Aim 2: Evaluate the impact of AD screening on family members' mood and anxiety.

Hypothesis 2: In comparison to the control group, family members randomized to the screening
only or the screening plus groups will express lower rates of depressive and anxiety symptoms
at 24 months as measured by the Patient Health Questionnaire (PHQ-9) and the Generalized
Anxiety Disorder Scale (GAD-7).

Specific Aim 3: Assess the impact of AD screening on family members' caregiving preparedness
and caregiving self-efficacy.

Hypothesis 3: In comparison to the control group, family members randomized to the screening
only or the screening plus group, will be more prepared for caregiving and have higher
self-efficacy at 24 months as measured by the Preparedness for Caregiving Scale and the
Revised Scale for Caregiving Self-Efficacy.

Specific Aim 4: Compare the effectiveness of two strategies for diagnostic evaluation and
management after AD screening.

Hypothesis 4: In comparison to the screening only group, family members randomized to the
screening plus group will express higher levels of health-related quality of life, caregiver
preparedness and caregiving self-efficacy and lower levels of depressive and anxiety symptoms
at 24 months, as measured by the SF-36, Preparedness for Caregiving Scale, the Revised Scale
for Caregiving Self-Efficacy, PHQ-9, and GAD-7, respectively.

Inclusion Criteria:

Patients

- 65 years or older

- At least one visit to primary care practice within past year

- Ability to provide informed consent

- Ability to communicate in English

Family Members

- 21 years or older

- Identified by the patient as the person most likely to provide them care if needed.*

- Lives with the patient or lives within a 50 mile radius.

- Ability to provide informed consent.

- Ability to communicate in English

Exclusion Criteria:

Patients

- Has a diagnosis of AD as determined by ICD-10 code.

- Evidence of a prescription for a cholinesterase inhibitors or memantine.

- Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10
code

- Permanent resident of a nursing facility

- Already seen by the Healthy Aging Brain Care Program

Family Member

- Is a non-family member who is not a legal Healthcare Power of Attorney

- Has serious mental illness such as bipolar or schizophrenia as determined by ICD-10
code

- Has a diagnosis of AD as determined by ICD-10 code.
We found this trial at
2
sites
Indianapolis, Indiana 46202
Principal Investigator: Malaz Boustani, MD
Phone: 317-274-9235
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Indianapolis, Indiana 46202
Phone: 317-274-9123
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Indianapolis, IN
Click here to add this to my saved trials