NCT07429591

Brief Summary

The goal of this clinical trial is to test a risk assessment screening and intervention for caregivers of people with dementia. The main questions it aims to answer are:

  • Complete two surveys, three months apart
  • Complete a 5-item screening tool, if assigned to one of the screening groups
  • Complete a 3-session caregiver intervention, if assigned to that group

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
May 2026Aug 2027

First Submitted

Initial submission to the registry

February 4, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

February 4, 2026

Last Update Submit

February 19, 2026

Conditions

Caregivers of Alzheimer's Disease or Memory Problem PatientsCaregiver WellbeingElder Abuse

Keywords

elder mistreatmentcaregiver wellnessDementia care

Outcome Measures

Primary Outcomes (4)

  • Caregiver Depression Symptoms

    Measured through Patient Health Questionnaire-8 score (0-24) .

    Enrollment to three months

  • Caregiver Anxiety Symptoms

    Measured by Generalized Anxiety Disorder-7 screening tool score (0-21) .

    Enrollment to three months

  • Caregiver Burden

    Measured by Zarit Burden Interview-6 scores (6-24)

    Enrollment to three months

  • Caregiver Stress About Care Receiver Behavioral Symptoms

    Measured by Neuropsychiatric Inventory Questionnaire scores (0-60)

    Enrollment to three months

Secondary Outcomes (13)

  • Elder Mistreatment

    Enrollment to three months

  • Healthcare Use of Person Living with Demenita

    Enrollment to three months

  • Dementia Knowledge

    Enrollment to three months

  • Caregiver Self Efficacy

    Enrollment to three months

  • Resilience

    Enrollment to three months

  • +8 more secondary outcomes

Study Arms (3)

Control

NO INTERVENTION

Participants will receive no intervention, only the two study surveys.

Risk Assessment Screening Only

EXPERIMENTAL

Participants will complete the risk assessment screening along with the two study surveys.

Behavioral: Risk Assessment Screening

Risk Assessment Screening and Coach Intervention

EXPERIMENTAL

Participants will complete the risk assessment screening, three coach sessions, intervention website, and the two study surveys.

Behavioral: Risk Assessment ScreeningBehavioral: Coach and Website Intervention

Interventions

Risk Assessment ScreeningBEHAVIORAL

A five question tool that can be delivered verbally or through written self-administration.

Risk Assessment Screening OnlyRisk Assessment Screening and Coach Intervention
Coach and Website InterventionBEHAVIORAL

A three-session community health worker intervention, including a caregiver information website.

Risk Assessment Screening and Coach Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or older
  • Speak English or Spanish
  • Caregiver for a person with Alzheimer's Disease or another type of dementia
  • Provide substantial care for this person, defined as assisting with at least one activity of daily living or two instrumental activities of daily living
  • See this person at least twice a week
  • Have access to the internet

You may not qualify if:

  • Under 18 years old
  • Speak language besides English or Spanish
  • Caregiver for person who does not have dementia
  • Do not provide substantial care for this person
  • Primary relationship between caregiver and person with dementia is that of a professional paid caregiver
  • Enrolled in another caregiver study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keck Medicine

Los Angeles, California, 90003, United States

Location

Study Officials

  • Bonnie Olsen, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Laura Mosqueda, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 24, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)