Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

4 sierpnia 2026 zaktualizowane przez: The University of Texas Medical Branch, Galveston

Applying a Family Caregiver Supports Needs Assessment Tool in Home-based Primary Care: An Approach to Elder Mistreatment Risk Reduction and Prevention

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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

80

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Karen E. Schlag, PhD
  • Numer telefonu: (409)772-1011
  • E-mail: keschlag@utmb.edu

Lokalizacje studiów

    • Texas
      • Galveston, Texas, Stany Zjednoczone, 77555
        • University of Texas Medical Branch
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
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.
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Recruitment Feasibility
Ramy czasowe: 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.
During participant recruitment (up to 12 months).
Participant Acceptability of CSNAT Intervention
Ramy czasowe: 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.
From posttest to two weeks following completion of the post-intervention assessment
Participant Retention
Ramy czasowe: 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.
From enrollment through completion of post-intervention assessments (approximately 1 month).
Intervention Adherence
Ramy czasowe: 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.
From intervention initiation through completion of the one-month follow-up discussion.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Caregiving Strain at One Month
Ramy czasowe: 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.

Baseline and one month
Change From Baseline in Caregiver Physical Health at One Month
Ramy czasowe: Baseline and one month
Assessed using the SF-12v2 Physical Component Summary (PCS). Higher scores indicate better physical health.
Baseline and one month
Change From Baseline in Caregiver Quality of Life at One Month
Ramy czasowe: 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.

Baseline to one month
Change from Baseline in Elder Mistreatment and Neglect Scores and Associations with Other Secondary Measures at One Month
Ramy czasowe: 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

Baseline and one month
Change From Baseline in Caregiver Mental Health at One Month
Ramy czasowe: Baseline to one month
Assessed using the SF-12v2 Mental Component Summary (MCS). Higher scores indicate better mental health.
Baseline to one month
Change From Baseline in Caregiver Depressive Symptoms at One Month
Ramy czasowe: 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.
Baseline to one month

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

1 lipca 2028

Ukończenie studiów (Szacowany)

1 września 2028

Daty rejestracji na studia

Pierwszy przesłany

29 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

6 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 25-0116
  • P30AG086563 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual, de-identified participant data will be shared only with the study team and grant principal investigators for oversight purposes. No external sharing is planned.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj