Recruiting

CSNAT

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT07749482

Conditions

Caregiver Stress

Caregiver Health Related QOL

Caregiver Mental Health

Caregiver Health Status

Recruitment of Participants

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

CSNAT-I

Study Details

Brief summary:

This study will evaluate the feasibility, acceptability, and preliminary effects of the Carer Support Needs Assessment Tool (CSNAT) intervention for family caregivers of older adults receiving home-based primary care. The CSNAT is a structured, caregiver-centered approach designed to identify caregiver support needs and facilitate supportive problem-solving conversations between clinicians and family caregivers.

Family caregivers will be assigned to either the CSNAT intervention or a comparison group receiving usual care. Feasibility will be evaluated through participant recruitment, retention, and intervention adherence. Acceptability will be assessed through qualitative interviews with caregivers who participate in the intervention.

The study will also examine the preliminary effects of the CSNAT intervention on caregiver outcomes, including caregiver strain, physical well-being, mental well-being, and emotional management. In addition, the study will explore whether improvements in caregiver well-being are associated with a reduced risk of situations that may contribute to harm or neglect of the older adult receiving care.

This pilot study will provide information on the practicality of implementing the CSNAT intervention in home-based primary care and will inform the design of future larger-scale studies.

Conditions

Caregiver Stress

Caregiver Health Related QOL

Caregiver Mental Health

Caregiver Health Status

Recruitment of Participants

Study ID

NCT07749482

Start date

Sep 29, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Be 18 years of age or older.
  • Self-report as providing consistent care to an older adult who receives medical home visits by a nurse practitioner as part of the UTMB Home-Based Primary Care (HBPC) Program.
  • Provides consistent care to an older adult which includes one or more of the following: a) Assistance with activities of daily living (ADLs), b) Medication management, c) Medical or nursing-related tasks
  • Provides consistent care to an adult age 65 years or older.
  • Be able to read, speak, and understand English.

Exclusion Criteria:

  • Does not provide consistent home care (including assistance with ADLs, medication management, or medical/nursing tasks)
  • Provides care to a patient who is under 65 years of age
  • Provides care to a patient not enrolled in the UTMB Health HBPC program
  • Provides care to a patient not receiving in-home visits by a nurse practitioner.
  • Is younger than 18 years of age
  • Is unable to read or speak English
  • Has an obvious neurological or psychiatric condition that may affect participation
  • Has communication deficits that may impact ability to participate

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Behavioral: Carer Support Needs Assessment Tool (CSNAT)

The Carer Support Needs Assessment Tool (CSNAT) is a caregiver-centered intervention designed to identify and address family caregiver support needs. The intervention includes completion of the CSNAT assessment followed by structured support and problem-solving discussions with a clinician to prioritize needs, develop action plans, and connect caregivers with available resources.

no intervention: Usual Care Control Group

Participants in this arm will receive usual home-based primary care services. As part of standard practice, family caregivers may engage in informal, ad hoc conversations with the visiting nurse practitioner regarding caregiving needs and concerns during routine home care visits for the older adult receiving care. Caregivers in this arm will not receive the structured Carer Support Needs Assessment Tool (CSNAT) intervention. Participants will complete study assessments at baseline and post-intervention.

Interventions

CSNAT-I

The CSNAT intervention is a structured, caregiver-centered approach that identifies caregiver support needs and facilitates clinician-led support and problem-solving discussions. The intervention includes completion of the CSNAT assessment, collaborative care planning with a nurse practitioner, and a follow-up review of action plan implementation approximately one month later. Audio recordings may be collected, with participant consent, to assess intervention fidelity.

Primary outcome measure

  • Recruitment Feasibility [ Time Frame: During participant recruitment (up to 12 months). ]
  • Participant Acceptability of CSNAT Intervention [ Time Frame: From posttest to two weeks following completion of the post-intervention assessment ]
  • Participant Retention [ Time Frame: From enrollment through completion of post-intervention assessments (approximately 1 month). ]
  • Intervention Adherence [ Time Frame: From intervention initiation through completion of the one-month follow-up discussion. ]

Central Contacts and Locations

Central contacts

Karen E. Schlag, PhD

(409)772-1011keschlag@utmb.edu

Locations

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77555

Contacts

Karen E. Schlag, PhD

409-772-1011keschlag@utmb.edu

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • elder mistreatment
  • caregiver support
  • homebased primary care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.