Caregiver Bootcamp

NCT07006116 | Recruiting

• 2 other identifiers: STUDY000074272P30AG064200-06
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the preliminary efficacy of a synchronous/asynchronous psychoeducation program designed to promote caregiving mastery in the immediate time period after a dementia diagnosis. It will also study the effects on caregiver and care recipient well-being.

Conditions

Dementia

Keywords

Caregiver; Dementia; Person living with dementia

Outcome Measures

Primary Outcomes (4)

• Change in caregiver sense of mastery

  The seven-item personal mastery scale developed by Pearlin and Schooler is used to measure mastery. All items are rated on a four-point scale: 1 = strongly agree; 2 = agree; 3 = disagree; to 4 = strongly disagree. Total scores ranged from 7 to 28, with higher scores indicating higher levels of mastery.

  Baseline, 1 and 3-months post-intervention

• Change in caregiver self-efficacy: symptom management scale

  This outcome will be assessed with Likert scale questions. Includes 6 questions, each scored on a 0-10 scale. Total possible score range is 0-60, with higher score correlating with better study outcome.

  Baseline, 1 and 3-months post-intervention

• Change in caregiver self-efficacy: support services scale

  This outcome will be assessed with Likert scale questions. Includes 4 questions, each scored on a 0-10 scale. Total possible score range is 0-40, with higher score correlating with better study outcome.

  Baseline, 1 and 3-months post-intervention

• Change in caregiver self-efficacy: medication management scale

  This outcome will be assessed with Likert scale questions. Includes 5 questions, each scored on a 0-10 scale. Total possible score range is 0-50, with higher score correlating with better study outcome.

  Baseline, 1 and 3-months post-intervention

Study Arms (1)

Synchronous/asynchronous online course Participants

EXPERIMENTAL

The program will combine 5 weekly small group (8 participants) 90-120-minute online sessions with asynchronous instructional materials delivered 2-4 days in between sessions. A time suited to all for the synchronous sessions will be identified. The research team will provide instructions for accessing the weekly sessions and asynchronous segments, and mail out supplemental course materials. The team will track online attendance, and the Canvas platform will enable them to monitor each individual's viewing of the asynchronous materials.

Other: Synchronous/asynchronous online course

Interventions

Synchronous/asynchronous online course OTHER

* Synchronous weekly 90-120-minute-long sessions that will be conducted on a videoconferencing platform (i.e., Zoom). If participants miss a synchronous session. * Asynchronous online course: available segments of the online course with asynchronous instructional materials delivered 2-4 days in between sessions, and supplemental course materials that will be received by mail.

Synchronous/asynchronous online course Participants

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over the age of 21;
• care partner/caregiver for a family or friend who has received a diagnosis of a form dementia from a healthcare provider in the last 6 months;
• has access to an electronic device and/or access to broadband internet; and
• able to speak and understand English. Caregivers are not required to be co-located with the care recipient.

You may not qualify if:

• considering moving the PLWD to an institutional setting within the next 6 months.

Sponsors & Collaborators

• Emory University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Nell Hodgson Woodruff School of Nursing

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Carolyn Clevenger, RN, DNP

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Clevenger, RN, DNP

CONTACT

404-712-2394; carolyn.clevenger@emory.edu

Molly Perkins, PhD

CONTACT

404-727-9676; molly.m.perkins@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The investigators will enroll caregivers in six cohorts of 8 each to participate in this Stage Ib clinical trial.

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Scientific data will be made available no later than the on-line publication of the main findings from investigators' final dataset and all other generated scientific data will be shared no later than the end of the project award. Study data for the trial will be stored in the Emory Roybal Center repository for at least 5 years.
• Access Criteria: De-identified data from Roybal-supported trials will be available to qualified researchers through a data sharing agreement that will be fully consistent with NIH data sharing policies and applicable laws and regulations as well as official policies and practices established by the Emory Roybal Center.

Locations

US (1)