Phase 4 of Designed With You

Официальное название

Building Active Living and Addressing Needs for Caregiver Empowerment (BALANCE) Study - Phase 4 of Designed With You

Обзор

The purpose of this study is to provide evaluate the feasibility of a structured 8-10-week, multi-component intervention that integrates individualized resource navigation, personalized self-care planning, emergency and end of life (EOL) preparedness, and peer support to improve the well-being, resource access and social connectedness of caregivers with disabilities. For this study we are interested in caregivers over the age of 18 who have some form (e.g. mobility or sensory) disability and are caring for a person with a disability and/or a chronic illness.

Подробное описание

The BALANCE is a feasibility study of the BALANCE intervention and will be delivered over 8-10 weeks. The proposed study is a Phase 1 feasibility trial designed to assess the feasibility and acceptability of a novel intervention aimed at \[briefly describe intervention\]. The primary objectives are to evaluate the practicality of implementing the intervention, participant engagement, and the appropriateness of study procedures.

Given the early-stage nature of this research, a control group is not required. Phase 1 feasibility studies are not intended to assess efficacy or comparative outcomes, but rather to refine the intervention and study logistics. According to guidance from the Office of Research Integrity (ORI), "Phase I trials are feasibility trials focused on developing and pretesting the acceptability, feasibility, and safety of the intervention components of Balance. "No control condition is needed."14 This approach aligns with best practices in early intervention development and allows for iterative refinement before proceeding to more rigorous testing in later phases (e.g., randomized controlled trials).

Вмешательства

• Поведенческое BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment
  The Balance intervention will include individual visits by a Caregiver Navigator and group sessions with other participants, led by the caregiver navigator. The focus will be on future planning, resources for unmet needs and support and socialization.

Первичные конечные точки

• Perceived Stress Scale [Срок оценки: Baseline and post intervention at approximately 10 weeks]
• Caregiver Burden Short Form [Срок оценки: Baseline and post intervention at approximately 10 weeks]
• Depressive Symptoms (PHQ-9) [Срок оценки: Baseline and post intervention at approximately 10 weeks]

Критерии участия

Критерии включения

• 18 years of age and older,
• Community dwelling in the state of Maryland,
• Self report of physical or sensory disability and
• self-report of serving as a family caregiver for a person for at least 10 hours/week.

Критерии исключения

• have a terminal diagnosis (<1 year expected survival), and
• > severe cognitive impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMQ)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Johns Hopkins School of Nursing — Baltimore

Идентификаторы

NCT: NCT07157995 · IRB00388844

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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