Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07461168
Brief Summary:
Care partners of people living with dementia often experience ongoing stress and unmet support needs. This study evaluates the feasibility of a low-intensity, supportive education and resource intervention for care partners who previously participated in an observational study.
Participants complete a baseline phone interview and a short stress journaling activity, followed by a six-week series of automated educational and supportive messages delivered by text message or email. Participants may also take part in an optional peer support focus group. The study examines caregiver stress, resilience, engagement with resources, and participant feedback to inform future caregiver support interventions.
Detailed Description:
Care partners of people living with dementia often experience high levels of stress, burden, and unmet support needs, particularly during transitions of care. Even after participating in prior observational research, caregiving demands and stressors may evolve over time, highlighting the need for ongoing education and support.
This is a mixed-methods, minimal-risk interventional study designed to evaluate the feasibility and utility of a low-intensity, supportive education and resource intervention for care partners of people living with dementia. Participants eligible for this study are care partners who previously completed an approved observational study conducted in the emergency department setting.
The study consists of three sequential phases. In the first phase, participants complete a baseline telephone interview assessing caregiver stress, burden, resilience, technology literacy, and caregiving experiences. Participants also complete a brief, structured stress journaling activity over a two-week period to document daily caregiving-related stressors.
In the second phase, participants receive a six-week series of automated educational and supportive messages delivered by text message or email. These messages provide dementia caregiving education, stress and grief management strategies, and links to publicly available caregiver resources. Brief check-in surveys are used to assess participant engagement, perceived usefulness of the materials, and caregiving stressors during this period.
In the final phase, participants are invited to attend an optional, in-person peer support focus group facilitated by trained study personnel. The focus group provides an opportunity for participants to share experiences, discuss caregiving needs, and provide qualitative feedback on the intervention. Sessions are audio recorded for qualitative analysis.
The primary goals of this continuation supplement are to assess the feasibility of delivering supportive educational resources to care partners using low-touch methods, evaluate changes in caregiver stress and resilience, and gather qualitative feedback to inform future caregiver support interventions.
Study:
NCT07461168
Study Brief:
Protocol Section:
NCT07461168