Primary Care-based Study of an Online Workshop for Family Caregivers of PLWD

NCT06928467 | Completed

• 2 other identifiers: Brown IRB ID: STUDY00000388U54AG063546
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 2

Brief Summary

Many family and friend caregivers of persons living with dementia experience depression, stress, and other adverse health consequences due to the responsibilities of their caregiving role. These caregivers express a desire for education and support. The overarching goal of this project is to improve education and support for caregivers of persons living with dementia so that they can take better care of themselves and also their person living with dementia. Building Better Caregivers workshop is an online, 6-week, small group workshop for family caregivers of persons living with dementia that teaches them caregiving skills and how to manage difficult emotions, stress, and other challenging aspects of caregiving. Caregivers also receive support from other caregivers and two trained workshop facilitators and a workbook to keep. The workshop uses asynchronous delivery that allows caregivers to use materials at home when they have time day or night, self-pace their learning, and chat with other caregivers through threaded discussion board conversations. In this pilot embedded pragmatic clinical trial the investigators will evaluate the workshop among 108 caregivers who receive health care in urban areas of California and rural areas of New York. To achieve the project goals the investigators will (1) determine the feasibility of identifying, enrolling, and randomizing caregivers to a workshop group or wait-list group; (2) assess the feasibility of using electronic health record data as study outcomes, including depressive symptoms of caregivers and emergency room visits and hospitalizations of their patients with dementia; and (3) determine whether caregivers complete the workshop and think it is acceptable. If this pilot trial is successful, the investigators will have the information necessary to conduct a larger study among many additional caregivers with the long-term goal of improving their health and the well-being of their person with dementia.

Conditions

Family Caregivers; Dementia; Self-management; Depression; Internet-based Intervention

Outcome Measures

Primary Outcomes (1)

• 3a. Percent of enrolled caregivers who complete caregiver depressive symptoms (PHQ-8) survey questions

  Percentage of enrolled caregivers who complete caregiver depressive symptoms survey questions from the 8-item Patient Health Questionnaire (PHQ-8), with score range 0-24 (higher score indicates worse depressive symptoms), with range 0% to 100% (higher percentage indicates higher completion rate).

  Up to 4 months

Secondary Outcomes (1)

• 3b. Healthcare utilization of emergency room visits and hospitalizations by person living with dementia

  Up to 5.5 months

Other Outcomes (5)

• 1a. Percent of invitation letters that are unread

  Baseline

• 1b. Percent of eligible caregivers for whom contact is attempted who enroll

  Baseline

• 2a. Percent of caregivers assigned to workshop who complete workshop

  Up to 6 weeks

Study Arms (2)

Workshop

EXPERIMENTAL

A 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia.

Behavioral: Building Better Caregivers workshop

Control

NO INTERVENTION

Wait-list control group.

Interventions

Building Better Caregivers workshop BEHAVIORAL

The BBC workshop is a 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia or other form of cognitive impairment. It is an evidence-based workshop of the Self-Management Resource Center originally developed at Stanford University for the Veterans Administration and is now licensed for online delivery by Canary Health. Content focuses on increasing participant self-management behaviors, dementia caregiving skills, and peer social support. The workshop uses a peer-facilitated small group format with frequent online interactions between approximately 27 participants on threaded discussion boards. Activities are guided by two trained peer co-facilitators (caregivers themselves). Each week focuses on 2-3 new topics and tools for participants to learn and use. In threaded discussion board conversations participants interact, help each other, and provide peer social support.

Workshop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years and older (no upper limit)
• Sex/Gender: any sex, any gender
• Race/ethnicity: any race/ethnicity
• Able to read and write in English
• Have internet access on any device (computer, tablet, smartphone) but does not require high speed internet
• Provide care to a person living with dementia who is a primary care patient participating health system, i.e., UCSF or Bassett
• Receive own healthcare at participating health system, i.e., UCSF or Bassett

You may not qualify if:

• \- Investigator discretion for clinical safety or protocol adherence reasons, e.g., potential participant who might not be able to meet the time requirements of the study (anticipating a move)

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

The Mary Imogene Bassett Hospital dba Bassett Medical Center-Bassett Healthcare Network

Cooperstown, New York, 13326, United States

Location

Related Publications (5)

• Lorig K, Thompson-Gallagher D, Traylor L, et al. Building Better Caregivers: a pilot online support workshop for family caregivers of cognitively impaired adults. Journal of applied gerontology. 2012;31 423-437.

  BACKGROUND

• Santoyo-Olsson J, Lorig K, Romo EM, Luzanilla M, Ramirez GA, Cheng J, Chesla C, Covinsky KE, Karliner L, Thompson DG, Fahrenwald N, Yank V. Study protocol for a hybrid effectiveness-implementation trial of the Building Better Caregivers online workshop for rural family/friend caregivers of people living with dementia. Contemp Clin Trials. 2022 Oct;121:106903. doi: 10.1016/j.cct.2022.106903. Epub 2022 Aug 31.

  PMID: 36057375 BACKGROUND

• Yank V, Gale RC, Nevedal A, Okwara L, Koenig CJ, Trivedi RB, Dupke NJ, Kabat M, Asch SM. Improving Uptake of a National Web-Based Psychoeducational Workshop for Informal Caregivers of Veterans: Mixed Methods Implementation Evaluation. J Med Internet Res. 2021 Jan 7;23(1):e16495. doi: 10.2196/16495.

  PMID: 33410759 BACKGROUND

• Lorig K, Ritter PL, Laurent DD, Yank V. Building Better Caregivers: A Pragmatic 12-Month Trial of a Community-Based Workshop for Caregivers of Cognitively Impaired Adults. J Appl Gerontol. 2019 Sep;38(9):1228-1252. doi: 10.1177/0733464817741682. Epub 2017 Nov 14.

  PMID: 29165000 BACKGROUND

• 2023 Alzheimer's disease facts and figures. Alzheimers Dement. 2023 Apr;19(4):1598-1695. doi: 10.1002/alz.13016. Epub 2023 Mar 14.

  PMID: 36918389 BACKGROUND

MeSH Terms

Conditions

Dementia; Depression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Veronica Yank, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Principal investigator and biostatistician
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 15, 2025
• Study Start: March 19, 2025
• Primary Completion: January 21, 2026
• Study Completion: February 9, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)