Caregiver Outcomes of Alzheimer's Disease Screening

NCT03300180 | Completed Results DMC

• 2 other identifiers: 17056492055R01AG056325-05
• Study Type: interventional
• Target: 1,822
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Short Form Health Survey (SF-36)

  The SF-36 is a general population instrument that measures health-related quality of life, mental, physical, and social functioning. It includes one multi-item scale that assesses 8 overall health concepts. These concepts are aggregated into a Physical Component Summary and a Mental Component Summary. The eight domains are combined to reach two summary scores for Physical and Mental Health which are standardized to a mean of 50, with a score above 50 representing better than average and below 50 poorer than average function.

  24 month

Secondary Outcomes (4)

• Depressive Symptoms

  PHQ-9 results for patient & family member at 24 months

• Anxiety Symptoms

  24 month GAD-7 scores for Family members & Patients

• Caregiving Preparedness

  24 month

• Caregiving Self Efficacy

  24 month result for Family member

Study Arms (3)

Control

NO INTERVENTION

The patients in this group will receive no AD screening

Screening Only

ACTIVE COMPARATOR

The patients in this group will receive screening for AD. Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic and some information about local clinical resources for them to peruse regarding follow-up care. The patient's PCP is also be notified of the screening results via EHR message.

Other: Screening Only

Collaborative Dementia Care Program

EXPERIMENTAL

The patients in this group will receive screening for AD, Patients and family members will receive a letter about how the patient performed on the screening. If they screen positive (e.g. ≤5 on the MIS-T or ≤2 on the Mini-Cog), the patient and family member will receive an infographic. Also, the family member will receive two follow-up phone calls. One from the COADS Study Coordinator and one from a care coordinator at the Aging Brain Care Program (ABC). This phone call will include an opportunity for the family to ask questions and a conversation about the program and diagnostic evaluation and management. Dyads have the option to refuse the follow-up visit. The patient's PCP is also be notified of the screening results via EHR message,

Behavioral: Collaborative Dementia Care Program

Interventions

Collaborative Dementia Care Program BEHAVIORAL

Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.

Collaborative Dementia Care Program

Screening Only OTHER

The patients in this group will receive screening for AD coupled with letters sent to the dyads and the primary care PCP informing them of the results of the screening

Screening Only

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients
• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

IU Health-Primary Care Clinics

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 32075686 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

The study staff completed recruitment despite adjustments from Covid-19. Yet, because of the long follow up period, 24-month assessments, we will requested a no cost extension to complete all outcome data collection and analysis. The official award end date was February 28, 2023 and a 12-month NCE extended the project to February 28, 2024, allowing time for data quality check, data analysis and study closeout.

Results Point of Contact

• Title: Nicole R. Fowler, PhD, MHSA; Associate Professor of Medicine
• Organization: Indiana University School of Medicine; Indiana University Center for Aging Research; Regenstrief Institute, Inc.

fowlern@iu.edu

317-274-9021

Study Officials

• Nicole Fowler, PHD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist, Indiana University Center for Aging Research

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: October 3, 2017
• Study Start: October 15, 2018
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: May 2, 2025
• Results First Posted: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)