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:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT06831318
Brief Summary:
The main purpose of this intervention study is to test if the community health worker (CHW)-led care transition support intervention is feasible and acceptable to the persons living with dementia (PLWD)'s caregivers, and other healthcare providers.
Main hypotheses of the study are:
1. the CHW interventionist will adhere to the intervention protocol with the score of 80% or higher on the intervention fidelity checklist throughout the intervention delivery period;
2. caregiver participants in the intervention group will rate the intervention, and the CHW interventionist to be helpful and satisfactory at the end of the intervention;
3. intervention feasibility (as measured by intervention completion rate, i.e., number of participants completing the telephone sessions with the CHW coach, and participant assessment completion rate, i.e., number of participants completing each study assessment at baseline, 6, 12 weeks) will be at equal to or higher than 80%; and
4. intervention participants - patient and caregiver - outcomes will improve at post-discharge Week 12 follow up from baseline and Week 6.
Detailed Description:
This study is a single-site, single-arm feasibility study with hospitalized person living with dementia (PLWD) and their family caregiver dyads receiving the community health worker (CHW)-led Care Transition Intervention to obtain preliminary data on the intervention's acceptability, feasibility, and potential efficacy. In addition to evaluation PLWD and caregiver outcomes, multiple stakeholders from two hospitals (Dell Seton Medical Center and Ascension Seton Medical Center Austin) will be interviewed focusing on intervention relevance for healthcare system and provider stakeholder priorities and feasibility and acceptability of integration into everyday workflows. Mixed methods (individual interviews, chart reviews) study will be conducted to gather views of various stakeholders at two hospital sites including PLWD and family caregivers, frontline providers and care staff, administrators, and information technology staff.
Of the two hospitals, Dell Seton Medical Center and Ascension Seton Medical Center Austin, Dell Seton Medical Center (DSMC) will be the main study site where the intervention and recruitment of dyads will take place. At Ascension Seton Medical Center Austin (ASMCA), staff will be interviewed to assess the feasibility and acceptability of the intervention to determine if future implementation at ASMCA is possible.
PLWD and caregiver target enrollment for this study is 80 English- or Spanish-speaking family caregivers and 80 of their care recipients who meet the eligibility criteria. The intervention will be led by a bilingual (English and Spanish speaking) CHW who is trained in the intervention.
The intervention process starts with the family assessment by the CHW, which identifies primary and secondary caregiving stressors, resources and social support availability, and needs for support as related to social determinants of health, dementia education, care navigation, caregiver health and burden. Closer to discharge, the CHW will again make contact with the family caregiver to review the post-discharge care plan and to help the family caregiver develop a plan for post-discharge care. Dyads will receive a curated individualized dementia caregiving toolkit. All meetings with the caregiver during patient's hospitalization will be done in person, via telephone or via zoom, whichever the caregiver prefers. Within the first week of discharge, the CHW will meet via telephone or Zoom with the dyad to review the goals, additional support needs such as care navigation, access to social services, and any other concerns. During the first month after discharge, the CHW will continue to provide weekly or bi-weekly telephone/zoom check-ins as needed for coaching, focused dementia and caregiving education, or navigation support, and provide approximately four additional bi-weekly check-in sessions with the caregiver for the following two months. Each telephone check-in session will last approximately 30-45 minutes and will include a brief review of the goals, a check in regarding the well-being of caregiver and PLWD and will address any questions or needs regarding post-discharge care navigation.
Caregiver study participant assessments will be conducted by telephone at baseline, at around 6 weeks (4-6 weeks depending on the availability of the caregiver), and at around 12 weeks (12-14 weeks depending on the availability of the caregiver) post-discharge. The GRA will also conduct chart reviews to gather additional patient outcome data. The primary outcomes of this pilot trial are acceptability, feasibility, and fidelity.
Interviews will be conducted with the CHW interventionist, palliative care team members, other primary care team members, information technology (IT) staff and/or other relevant staff at both study sites (DSMC and ASMCA) using in-depth interviews to explore acceptability and feasibility of the intervention. In addition, interviews will be conducted with key stakeholders and informants before and after the intervention is implemented. The goal of these interviews is to identify any additional challenges or priorities stakeholders experience during transitions of care that our intervention needs to consider. Stakeholders will include hospital staff from two sites (DSMC and ASMCA), content experts on dementia and caregiving (e.g., clinicians, service providers, scholars on this topic area), community organization providers for older adults and people living with dementia or their families, and formal or current dementia caregivers. Participants may be asked to participate in in-depth interviews multiple times, before the intervention is implemented, during the implementation period, and after the intervention has been implemented. Using a semi-structured interview (in person, phone, or zoom, whichever the participant prefers) which will take approximately 30-60 minutes.
To analyze the acceptability and feasibility of the protocol and barriers to recruitment and retention as well as systemwide implementation, analytic techniques for mixed methods study will be used such as content analyses and descriptive methods. All quantitative data analyses (e.g., descriptive, correlation,) will be conducted with SPSS v24 and R software. All qualitative interviews will be digitally-recorded and will be transcribed verbatim by a professional transcription service, and uploaded into Dedoose qualitative analysis software. A coding scheme and a codebook will be developed; codes will consist of externally-generated codes based on a predetermined conceptual framework, and internally-generated codes that emerge from the analysis with focus on codes reflecting potential difficulties with the intervention; opinions about the length and number of sessions; the delivery method; stakeholder priorities; implementation challenges and barriers; etc. Member checking will be ongoing from interview to interview. To corroborate findings and establish trustworthiness, an audit trail will be kept and co-investigators will be convened to provide critical feedback on the emerging codes. Data will be reviewed within and across coded texts in order to extract converging themes and reach consensus on principal themes.
Study:
NCT06831318
Study Brief:
Protocol Section:
NCT06831318