Applying CSNAT in HBPC as an Approach to Elder Mistreatment Risk Reduction

NCT07749482 | Not Yet Recruiting

• 2 other identifiers: 25-0116P30AG086563
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 Health Related QOL; Caregiver Mental Health; Caregiver Health Status; Elder Mistreatment; Caregiver Stress; Recruitment of Participants

Keywords

elder mistreatment; caregiver support; homebased primary care

Outcome Measures

Primary Outcomes (4)

• Recruitment Feasibility

  Recruitment feasibility will be assessed by the time from identification of a potential participant to enrollment, participant refusal rate, and average time required to enroll 20 caregivers per study arm.

  During participant recruitment (up to 12 months).

• Participant Acceptability of CSNAT Intervention

  Acceptability of the CSNAT intervention will be assessed through semi-structured qualitative interviews conducted with intervention participants who complete the study intervention. Interviews will explore: (1) caregiver experiences and caregiving-related stressors; (2) caregiver support needs; (3) participant experiences with and perceptions of the CSNAT intervention; and (4) barriers and facilitators to participation in the intervention. Interview data will be analyzed to identify themes related to the acceptability, perceived usefulness, and implementation of the intervention.

  From posttest to two weeks following completion of the post-intervention assessment

• Participant Retention

  Retention will be assessed as the proportion of enrolled participants who complete both baseline and post-intervention assessments.

  From enrollment through completion of post-intervention assessments (approximately 1 month).

• Intervention Adherence

  Intervention adherence will be assessed as the proportion of participants in the intervention arm who complete the CSNAT assessment and both planned support discussions with the nurse practitioner.

  From intervention initiation through completion of the one-month follow-up discussion.

Secondary Outcomes (6)

• Change from Baseline in Caregiving Strain at One Month

  Baseline and one month

• Change From Baseline in Caregiver Physical Health at One Month

  Baseline and one month

• Change From Baseline in Caregiver Quality of Life at One Month

  Baseline to one month

• Change from Baseline in Elder Mistreatment and Neglect Scores and Associations with Other Secondary Measures at One Month

  Baseline and one month

• Change From Baseline in Caregiver Mental Health at One Month

  Baseline to one month

Study Arms (2)

Behavioral: Carer Support Needs Assessment Tool (CSNAT)

EXPERIMENTAL

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.

Behavioral: CSNAT-I

Usual Care Control Group

NO INTERVENTION

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 BEHAVIORAL

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.

Behavioral: Carer Support Needs Assessment Tool (CSNAT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead
• National Institute on Aging (NIA): collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (7)

• Naumann VJ, Byrne GJ. WHOQOL-BREF as a measure of quality of life in older patients with depression. Int Psychogeriatr. 2004 Jun;16(2):159-73. doi: 10.1017/s1041610204000109.

  PMID: 15318762 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Ayalon L. Reports of Elder Neglect by Older Adults, Their Family Caregivers, and Their Home Care Workers: A Test of Measurement Invariance. J Gerontol B Psychol Sci Soc Sci. 2015 May;70(3):432-42. doi: 10.1093/geronb/gbu051. Epub 2014 May 23.

  PMID: 24859223 BACKGROUND

• Beach SR, Schulz R, Williamson GM, Miller LS, Weiner MF, Lance CE. Risk factors for potentially harmful informal caregiver behavior. J Am Geriatr Soc. 2005 Feb;53(2):255-61. doi: 10.1111/j.1532-5415.2005.53111.x.

  PMID: 15673349 BACKGROUND

• Cooper B, Kinsella GJ, Picton C. Development and initial validation of a family appraisal of caregiving questionnaire for palliative care. Psychooncology. 2006 Jul;15(7):613-22. doi: 10.1002/pon.1001.

  PMID: 16287207 BACKGROUND

• Grande GE, Austin L, Ewing G, O'Leary N, Roberts C. Assessing the impact of a Carer Support Needs Assessment Tool (CSNAT) intervention in palliative home care: a stepped wedge cluster trial. BMJ Support Palliat Care. 2017 Sep;7(3):326-334. doi: 10.1136/bmjspcare-2014-000829. Epub 2015 Dec 30.

  PMID: 26719349 BACKGROUND

• Aoun SM, Grande G, Howting D, Deas K, Toye C, Troeung L, Stajduhar K, Ewing G. The impact of the carer support needs assessment tool (CSNAT) in community palliative care using a stepped wedge cluster trial. PLoS One. 2015 Apr 7;10(4):e0123012. doi: 10.1371/journal.pone.0123012. eCollection 2015.

  PMID: 25849348 BACKGROUND

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Karen E. Schlag, PhD

CONTACT

(409)772-1011; keschlag@utmb.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)