Caregiver Health Related QOL, Caregiver Health Status, Caregiver Mental Health, Caregiver Stress, Elder Mistreatment, Recruitment of Participants
Conditions
Keywords
elder mistreatment, caregiver support, homebased primary care
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.
Detailed description
Family caregivers play a crucial role in the care of older adults with health and daily living needs at home. At the same time, caregiving in this context can be stressful and demanding, and family members can experience strain, poor health, and unmet support needs. These circumstances can further impact the older adults they care for, including creating unwanted risks to their health and safety. Caregivers of patients receiving home-based primary care may be especially likely to experience these challenges because many patients have multiple health conditions and require extensive support. The Carer Support Needs Assessment Tool (CSNAT) is a structured approach where caregivers identify and prioritize areas where they need support by responding to the CSNAT questionnaire (i.e., tool). The tool covers 15 areas related to both caregiving responsibilities and caregivers' own well-being. After completing the questionnaire/tool, caregivers use their responses to the CSNAT to shape discussions about their care needs with a healthcare provider. Together, the caregiver and clinician create a plan to address identified support needs and later review progress and any additional needs. This study will evaluate whether the CSNAT approach can be successfully used with family caregivers of older adults receiving home-based primary care. Eighty caregivers will be randomly assigned to either a CSNAT intervention group or a usual-care control group. Caregivers in the intervention group will complete the CSNAT, participate in a support planning discussion with a nurse practitioner, and take part in a follow-up discussion approximately one month later. Caregivers in the control group will receive usual care, which may include informal conversations with their healthcare provider about caregiving needs. Researchers will assess the practicality and acceptability of the CSNAT approach by examining recruitment, participation, retention, and completion of study activities. The study will also collect information on caregiver strain, caregiver physical and mental well-being, and factors related to risk of elder mistreatment before and after the study period. In addition, interviews with a subset of caregivers in the intervention group will be conducted to better understand their experiences with the CSNAT approach.
Interventions
BEHAVIORALCSNAT-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.
Sponsors
The University of Texas Medical Branch, Galveston
National Institute on Aging (NIA)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility | During participant recruitment (up to 12 months). | 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 | From posttest to two weeks following completion of the post-intervention assessment | 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 | From enrollment through completion of post-intervention assessments (approximately 1 month). | Retention will be assessed as the proportion of enrolled participants who complete both baseline and post-intervention assessments. |
| Intervention Adherence | From intervention initiation through completion of the one-month follow-up discussion. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Caregiving Strain at One Month | Baseline and 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 | Baseline and 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 | Baseline to 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 | Baseline and 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 |
| Change From Baseline in Caregiver Mental Health at One Month | Baseline to one month | Assessed using the SF-12v2 Mental Component Summary (MCS). Higher scores indicate better mental health. |
| Change From Baseline in Caregiver Depressive Symptoms at One Month | Baseline to one month | Assessed using the Patient Health Questionnaire-9 (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. |
Countries
United States
Contacts
CONTACTKaren E. Schlag, PhD
Outcome results
None listed