Community Health Worker-Led Transition Support for Persons Living With Dementia and Caregivers

NCT06831318 | Recruiting

• 1 other identifier: STUDY00004286
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 4.intervention participants - patient and caregiver - outcomes will improve at post-discharge Week 12 follow up from baseline and Week 6.

Conditions

Cognitive Impairment; Dementia; Memory Deficits

Keywords

caregiver; care transition; community health worker; dementia; cognitive impairment

Outcome Measures

Primary Outcomes (4)

• Caregiver Acceptability

  Participants will be asked about acceptability using 7 items with Likert type scales which were developed by the research team to assess: (1) if the caregiver liked meetings with CHW (1=strongly dislike, 5=strongly like); (2) how much efforts the caregiver had to put in meeting with CHW (1=no effort at all, 5=huge effort); (3), if the CHW support was fair (1=very unfair, 5=very fair); (4) if the CHW support improved the patient experience (1=strongly disagree, 5=strongly agree); (5) if it was clear to the caregiver how the CHW support will improve the caregiver's ability to care for the patient (1=strongly disagree, 5=strongly agree); (6) how confident the caregiver was in participating meetings with the CHW (1=very unconfident, 5=very confident); and (7) overall rating of the acceptability of the intervention in support the caregiver (1=completely unacceptable, 5=completely acceptable).

  At post-discharge Week 12 follow up.

• Study Feasibility

  Feasibility will be assessed by study enrollment rate (percentage of eligible persons enrolled in the study), and participant assessment completion rate (number of participants completing each study assessment at baseline, Post-discharge Week 6 and Post-discharge Week 12 follow-up). Consistent with other pilot intervention studies, 25% rate of enrollment, equal or higher than 70% completion rates for study assessments will be considered as evidence of feasibility.

  Assessing feasibility begins with their enrollment (at Baseline) and ends with their final scheduled visit with the CHW (at Post-discharge Week 12 follow-up).

• Fidelity

  We will select approximately 20% of participants' interview recordings (at least one initial assessment and at least one follow-up CHW sessions), review and apply the fidelity checklist. The fidelity assessment was developed by the research team to evaluate CHW performance across key competencies using a structured scale. Nine items assess the CHW's skills and action including ability to accurately explain their role, convey a positive, non-judgmental attitude, active listening skills (e.g., reflection, validation, summarizing) and supportive responses to emotions are measured (scored 3 if consistent/always, 2 if inconsistent/sometimes, and 1 if absent/rarely). Four items assess presence of CHW following the crisis intervention model elements, e.g., facilitating the patient's immediate needs (scored 3 if present, 0 if absent). Assessment and follow-up form completeness is scored with 4 if 80% or higher, and 0 if less than 80%.

  CHW Initial Assessment Meeting (within the first week of enrollment), 1st CHW Follow-Up Meeting (within 4 weeks of the initial assessment meeting) and 2nd CHW Follow-Up Meeting (within 4 weeks of the 1st follow-up meeting)

• Intervention Feasibility

  Feasibility will be assessed by intervention completion rate (number of participants completing the telephone sessions with the CHW ) Consistent with other pilot intervention studies, ≥70% completion rates for intervention session.

  Baseline, Post-Discharge Week 6 Follow-up, Post-Discharge Week 12 Follow-up

Secondary Outcomes (6)

• PWLD quality of life

  Post-Discharge Week 6 Follow-up, Post-Discharge Week 12 Follow-up

• PLWD 30- and 90- day hospital and ED readmissions

  Post-Discharge Week 6 Follow-up, Post-Discharge Week 12 Follow-up

• Caregiver burden

  Post-discharge Week 6 Follow-up, Post-discharge Week 12 Follow-up

• Caregiver well-being

  Post-discharge Week 6 Follow-up and Post-discharge Week 12 Follow-up

• Care transition quality

  Post-discharge Week 6 Follow-up, Post-discharge Week 12 Follow-up

Study Arms (1)

CHW intervention group

EXPERIMENTAL

dementia patient and caregiver dyad

Behavioral: Community Health Worker (CHW) Guided Support

Interventions

Community Health Worker (CHW) Guided Support BEHAVIORAL

The CHW conducts a family assessment, which identifies caregiving stressors, social support, and needs as related to social determinants of health, dementia education, care navigation, caregiver health and burden. Closer to discharge, dyads receive an individualized dementia caregiving toolkit including the post-discharge care planning checklist, tracking sheets for patient medications, tests, and procedures, and info on local resources. All meetings will be done in person, telephone, or zoom. Within one week of discharge, the CHW meets the dyad via phone or Zoom to review their goals and to identify any additional needs for coaching, education, or navigation support. In the first month after discharge, the CHW provides weekly or bi-weekly check-ins. For the next two months, the CHW provides about four additional bi-weekly check-in sessions. Each check-in session will last approximately 30-45 minutes. The exact number of meetings will be determined by need and caregiver availability

CHW intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized Patients:
• Aged 50 or older
• Has confirmed or suspected dementia or cognitive impairment (i.e., having memory concerns) ;
• Has FAST score 4-6;
• Admitted from home (not a long-term care facility)
• Family Caregiver:
• Aged 18 or older;
• English or Spanish speaking;
• Patient's relative, or partner who assists with medical care on a regular basis and who may or may not live in the same residence and who is not paid for their help; and
• Legally authorized representative (LAR) for the patient if the patient is not able to consent for themselves in the study.
• Staff Participants:
• Aged 18 and older,
• English speaking,
• Employed full-time or part-time at or affiliated with either site, and
• Involved directly or indirectly with patient care (i.e., administrative or non-clinical support staff) such as: nurses, physicians, physician assistants, care managers, social workers, chaplains, discharge planners, IT staff, administrative managers

You may not qualify if:

• Hospitalized Patients:
• Patients who do not meet eligibility criteria
• Patients who are eligible for hospice
• Caregivers:
• \. Caregivers who do not meet the eligibility criteria
• Staff participants:
• Staff who do not meet the eligibility criteria
• Staff who do not speak English
• Key Informants:
• \. Individuals who do not meet the eligibility criteria

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Seton Medical Center

Austin, Texas, 78701, United States

RECRUITING

Related Publications (2)

• Kwak J, Kvale E, Mills S, Patel S. Co-designing a stage 1B feasibility study of inpatient palliative community health worker support. Innov Aging. 2023;7(suppl 1):337-338. https://doi.org/10.1093/geroni/igad104.1124

  BACKGROUND

• Kwak J, Jafari A, Salter A, Perry A, de Montfort Shepherd A, Jayasundera M, Stayer S, Brode M, Patel S, Kvale E. CEDART Study: protocol for a non-randomized feasibility study. Res Sq [Preprint]. 2025 May 13:rs.3.rs-6378596. doi: 10.21203/rs.3.rs-6378596/v1.

  PMID: 40470215 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Memory Disorders

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Jung Kwak, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung Kwak, PhD

CONTACT

512-471-7945; jkwak@nursing.utexas.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: SPONSOR

Model Details: This study is a single-site, single-arm feasibility study with between 40 and 80 hospitalized dyads receiving the CHW-led Care Transition Intervention to obtain preliminary data on the intervention's acceptability, feasibility, and potential efficacy.

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 18, 2025
• Study Start: August 12, 2024
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start date: January 1, 2027; end date: December 31, 2029
• Access Criteria: All raw data accessibility will be limited to the PI, data manager, GRAs, and the statistician. Data will be shared under a two-tier distribution system. All data that can be de-identified will be publicly shared. Data with increased risk of reidentification will be shared under a data-use agreement that clearly establish use rules to facilitate respondent confidentiality. We will make these data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. After review of the purpose of the data request to make sure it is consistent with the original project goals and verification that the request meets IRB approval, de-identified data may be shared with researchers.

Locations

US (1)