About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
CSNAT-I
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Participant Retention
Retention will be assessed as the proportion of enrolled participants who complete both baseline and post-intervention assessments.
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.
Secondary outcomes
Change from Baseline in Caregiving Strain at One Month
Caregiving strain will be assessed using the 8-item Strain subscale of the Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC). The subscale evaluates caregiving burden related to role overload and role captivity. Items are rated on a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree). Responses are summed and/or averaged according to instrument scoring guidelines, with higher scores indicating lower levels of caregiving strain. Outcome Measure: Change in caregiving strain score from baseline to 1 month. The change score will be calculated as the 1-month score minus the baseline score. Positive values indicate a reduction in caregiving strain, while negative values indicate an increase in caregiving strain.
Change From Baseline in Caregiver Physical Health at One Month
Assessed using the SF-12v2 Physical Component Summary (PCS). Higher scores indicate better physical health.
Change From Baseline in Caregiver Quality of Life at One Month
Caregiver quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF), a 26-item validated instrument that measures quality of life across four domains: Physical Health, Psychological Health, Social Relationships, and Environment. Items are rated on a 5-point Likert scale, with response options varying by item (e.g., 1 = very dissatisfied/not at all to 5 = very satisfied/completely). Domain scores are calculated according to instrument scoring guidelines, with higher scores indicating better quality of life. Change in caregiver quality of life from baseline to 1 month, as measured by WHOQOL-BREF domain scores. Change scores will be calculated as the 1-month score minus the baseline score. Positive change values indicate improvement in quality of life.
Change from Baseline in Elder Mistreatment and Neglect Scores and Associations with Other Secondary Measures at One Month
Elder mistreatment will be assessed using the Potentially Harmful Behavior Scale (PHBS), a 10-item instrument that measures caregiver behaviors that may place the care recipient at risk of physical or psychological harm. Items are rated on a 5-point Likert scale ranging from 1 (never) to 5 (all of the time), with higher scores indicating more frequent potentially harmful behaviors. Caregiver neglect of the care recipient will be assessed using a 7-item Neglect Scale adapted to measure the frequency with which caregivers do not provide assistance with essential care needs, including medical care, activities of daily living, transportation, household tasks, nutrition, hygiene, and supervision. Items are rated on a 5-point Likert scale ranging from 1 (never/not relevant) to 5 (very frequently). Higher scores indicate a greater frequency of neglectful caregiving behaviors. Change in elder mistreatment and neglect scores from baseline to 1
Sponsors and contacts
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The University of Texas Medical Branch, Galveston
Lead sponsor
National Institute on Aging (NIA)
Collaborator
The University of Texas Health Science Center, Houston
Collaborator