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Набор скоро начнётся NCT07749482

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

Без фазы С лечением Caregiver Stress Caregiver Health Related QOL Caregiver Mental Health Caregiver Health Status

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: CSNAT-I.
Кому может быть актуально
Состояния в реестре: Caregiver Stress, Caregiver Health Related QOL, Caregiver Mental Health, Caregiver Health Status. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Recruitment Feasibility [Срок оценки: During participant recruitment (up to 12 months).]
  • Participant Acceptability of CSNAT Intervention [Срок оценки: From posttest to two weeks following completion of the post-intervention assessment]
  • Participant Retention [Срок оценки: From enrollment through completion of post-intervention assessments (approximately 1 month).]
  • Intervention Adherence [Срок оценки: From intervention initiation through completion of the one-month follow-up discussion.]
Вторичные конечные точки (6)
  • Change from Baseline in Caregiving Strain at One Month [Срок оценки: Baseline and one month]
  • Change From Baseline in Caregiver Physical Health at One Month [Срок оценки: Baseline and one month]
  • Change From Baseline in Caregiver Quality of Life at One Month [Срок оценки: Baseline to one month]
  • Change from Baseline in Elder Mistreatment and Neglect Scores and Associations with Other Secondary Measures at One Month [Срок оценки: Baseline and one month]
  • Change From Baseline in Caregiver Mental Health at One Month [Срок оценки: Baseline to one month]
  • Change From Baseline in Caregiver Depressive Symptoms at One Month [Срок оценки: Baseline to one month]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • University of Texas Medical Branch — Galveston

Публикации

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Идентификаторы

NCT: NCT07749482 · 25-0116 · P30AG086563

Первоисточники (государственные реестры)

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