Clinical trial NCT03300180: Caregiver Outcomes of Alzheimer's Disease Screening
Official title: Caregiver Outcomes of Alzheimer's Disease Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2017-10-03
Enrollment: 1822
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Patients

* 65 years or older
* At least one visit to primary care practice within past 24 months
* 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.

Primary outcomes:
measure: Short Form Health Survey (SF-36)
timeFrame: 24 month
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: PHQ-9 results for patient & family member at 24 months
measure: Anxiety Symptoms
timeFrame: 24 month GAD-7 scores for Family members & Patients
measure: Caregiving Preparedness
timeFrame: 24 month
measure: Caregiving Self Efficacy
timeFrame: 24 month result for Family member
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Hospital
state: Indiana
city: Indianapolis
country: United States
facility: IU Health-Primary Care Clinics
state: Indiana
Study officials:
affiliation: Indiana University
name: Nicole Fowler, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fowler NR, Head KJ, Perkins AJ, Gao S, Callahan CM, Bakas T, Suarez SD, Boustani MA. Examining the benefits and harms of Alzheimer's disease screening for family members of older adults: study protocol for a randomized controlled trial. Trials. 2020 Feb 19;21(1):202. doi: 10.1186/s13063-019-4029-5.