Cognitive ImpairmentCEDARTNCT06831318
Community Health Worker-Led Transition Support for Persons Living With Dementia and Caregivers
A study testing Community Health Worker (CHW) Guided Support in people with Cognitive Impairment and Dementia, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cognitive Impairment, Dementia, Memory Deficits
- What is being tested?
- Community Health Worker (CHW) Guided Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 25Show fewer
- 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
- Key Informants:
- For hospital staff key informants, same eligibility criteria as above
- For family caregivers (current or formal)
- Aged 18 or older;
- English or Spanish speaking;
- Currently or previously were caring for a relative with dementia
- Content experts or community service providers:
- Aged 18 or older;
- English or Spanish speaking;
- Have professional experience working with and/or have expertise about dementia care and caregiving or related areas (e.g., aging service providers, staff at Alzheimer's association, scholars in the area of aging, dementia, caregiving, or care transition)
Who cannot join
- Hospitalized Patients:
- Patients who do not meet eligibility criteria
- Patients who are eligible for hospice
- Caregivers:
- 1. Caregivers who do not meet the eligibility criteria
- Staff participants:
Show all 10Show fewer
- Staff who do not meet the eligibility criteria
- Staff who do not speak English
- Key Informants:
- 1. Individuals who do not meet the eligibility criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Health Worker-Led Hospital-to-Community Transition Support for Persons Living With Dementia and Their Caregivers
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:
- 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;
- 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;
- 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
- intervention participants - patient and caregiver - outcomes will improve at post-discharge Week 12 follow up from baseline and Week 6.
Read the 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.
- Conditions
- Cognitive Impairment, Dementia, Memory Deficits
- Being tested
- Community Health Worker (CHW) Guided Support
- Keywords
- caregiver, care transition, community health worker, dementia, cognitive impairment
- Medical subject headings
- Cognitive Dysfunction, Dementia, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker (CHW) Guided SupportBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| CHW intervention group | Experimental | dementia patient and caregiver dyad Receives: Behavioral: Community Health Worker (CHW) Guided Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: Baseline, Post-Discharge Week 6 Follow-up, Post-Discharge Week 12 Follow-up
Secondary outcomes (6)
PWLD quality of life
PWLD quality of life is measured by Quality of Life in Alzheimer's Disease (QoL-AD) scale (Reference: Torisson G, Stavenow L, Minthon L, Londos E. Reliability, validity and clinical correlates of the Quality of Life in Alzheimer's Disease (QoL-AD) scale in medical inpatients. Health Qual Life Outcomes. 2016;14:90.)
Measured: Post-Discharge Week 6 Follow-up, Post-Discharge Week 12 Follow-up
PLWD 30- and 90- day hospital and ED readmissions
PLWD's 30- and 90- day hospital and ED readmission rate will be assessed by asking the caregiver to report during the interview. They will be asked: how many times the PLWD was admitted to a hospital for any reason in the last 30 days and last 90 days and how many times the PLWD was admitted to an ER for any reason in the last 30 days and last 90 days.
Measured: Post-Discharge Week 6 Follow-up, Post-Discharge Week 12 Follow-up
Caregiver burden
Caregiver burden will be measured by the Zarit Burden Short Interview (Reference: Michel Bédard, D. William Molloy, Larry Squire, Sacha Dubois, Judith A. Lever, Martin O'Donnell, The Zarit Burden Interview: A New Short Version and Screening Version, The Gerontologist, Volume 41, Issue 5, 1 October 2001, Pages 652-657, https://doi.org/10.1093/geront/41.5.652)
Measured: Post-discharge Week 6 Follow-up, Post-discharge Week 12 Follow-up
Caregiver well-being
Caregiver well-being will be measured by COPE scale (Reference: Aguirre, A., Benge, J.F., Finger, A., Ambiee, J., Runnels, I., Hilsabeck, R. (2024) The Caregiver Outcomes of Psychotherapy Evaluation (COPE): Development of a Social Work Assessment Tool. Clinical Social Work Journal. https://doi.org/10.1007/s10615-024-00925-2)
Measured: Post-discharge Week 6 Follow-up and Post-discharge Week 12 Follow-up
Care transition quality
Care transition quality will be measured by the Family Caregiver Activation in Transitions (FCAT) Tool (Reference: Coleman EA, Ground KL, Maul A. The Family Caregiver Activation in Transitions (FCAT) Tool: A New Measure of Family Caregiver Self-Efficacy. Jt Comm J Qual Patient Saf. 2015;41(11):502-507.)
Measured: Post-discharge Week 6 Follow-up, Post-discharge Week 12 Follow-up
Post-discharge compliance
Post-discharge compliance will be measured by items adapted from Albrecht et al's discharge instruction comprehension measure about medications, follow-up appointments, diet, and exercise (Reference: Albrecht JS, Gruber-Baldini AL, Hirshon JM, et al. Hospital Discharge Instructions: Comprehension and Compliance Among Older Adults. J Gen Intern Med. 2014;29(11):1491-1498.)
Measured: Post-discharge Week 6 Follow-up, Post-discharge Week 12 Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start12 Aug 2024
- Primary completion31 Aug 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Kwak, University of Texas at Austin
- Investigators
- Jung Kwak, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831318
- Sponsor's protocol ID
- STUDY00004286
- Acronym
- CEDART
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 shared. Data with specific confidentially risks, such as individual-level digital recordings will not be shared publicly because of the difficulty masking the identity of participants. Data with increased risk of reidentification will be shared under a data-use agreement that clearly establish use rules to facilitate respondent confidentiality. Even though the final dataset comprising of questionnaire will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. These types of data will be only shared under a data sharing agreement: individual-level digital recordings, medical records review, and qualitative data from participants interviews (because of the difficulty masking).
Publications
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 Dec 21;7(Suppl 1):337-8. doi: 10.1093/geroni/igad104.1124. PMCID: PMC10738091.
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.
PubMed 40470215
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Worker-Led Hospital-to-Community Transition Support for Persons Living With Dementia and Their Caregivers
- ClinicalTrials.gov ID
- NCT06831318
- Acronym / sponsor ID
- CEDART / STUDY00004286
- Conditions
- Cognitive Impairment, Dementia, Memory Deficits
- Keywords
- caregiver, care transition, community health worker, dementia, cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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;
- 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
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CHW intervention group | Experimental | Behavioral: Community Health Worker (CHW) Guided Supportdementia patient and caregiver dyad |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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)
- Aged 18 or older;
Key exclusion criteria (10 listed)
- Patients who do not meet eligibility criteria
- Patients who are eligible for hospice
- 1. Caregivers who do not meet the eligibility criteria
- Staff who do not meet the eligibility criteria
- Staff who do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health Worker (CHW) Guided SupportThe 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 | Behavioural | CHW intervention group |
Primary outcome
Caregiver Acceptability
Time frame: At post-discharge Week 12 follow up.
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).
Study Feasibility
Time frame: 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).
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.
Fidelity
Time frame: 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)
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%.
Intervention Feasibility
Time frame: Baseline, Post-Discharge Week 6 Follow-up, Post-Discharge Week 12 Follow-up
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.
6 secondary outcomes
PWLD quality of life
Time frame: Post-Discharge Week 6 Follow-up, Post-Discharge Week 12 Follow-up
PLWD 30- and 90- day hospital and ED readmissions
Time frame: Post-Discharge Week 6 Follow-up, Post-Discharge Week 12 Follow-up
Caregiver burden
Time frame: Post-discharge Week 6 Follow-up, Post-discharge Week 12 Follow-up
Caregiver well-being
Time frame: Post-discharge Week 6 Follow-up and Post-discharge Week 12 Follow-up
Care transition quality
Time frame: Post-discharge Week 6 Follow-up, Post-discharge Week 12 Follow-up
Post-discharge compliance
Time frame: Post-discharge Week 6 Follow-up, Post-discharge Week 12 Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- BackgroundKwak J, Kvale E, Mills S, Patel S. CO-DESIGNING A STAGE 1B FEASIBILITY STUDY OF INPATIENT PALLIATIVE COMMUNITY HEALTH WORKER SUPPORT. Innov Aging. 2023 Dec 21;7(Suppl 1):337-8. doi: 10.1093/geroni/igad104.1124. PMCID: PMC10738091.
- Derived from this study: PubMed 40470215Kwak 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.
- Individual participant dataSharing planned: Yes. 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 shared. Data with specific confidentially risks, such as individual-level digital recordings will not be shared publicly because of the difficulty masking the identity of participants. Data with increased risk of reidentification will be shared under a data-use agreement that clearly establish use rules to facilitate respondent confidentiality. Even though the final dataset comprising of questionnaire will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. These types of data will be only shared under a data sharing agreement: individual-level digital recordings, medical records review, and qualitative data from participants interviews (because of the difficulty masking).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Kwak, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker (CHW) Guided Support in people with Cognitive Impairment and Dementia, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Acceptability (time frame: At post-discharge Week 12 follow up.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06831318, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.