Building Active Living and Addressing Needs for Caregiver Empowerment (BALANCE) Study - Phase 4 of Designed With You
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Perceived Stress Scale
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •have a terminal diagnosis (<1 year expected survival), and
- •> severe cognitive impairment (5-7 errors) based on the Short Portable Mental Status Questionnaire (SPMQ)
研究组 & 干预措施
Balance Intervention
Participants will receive the intervention. BALANCE is a feasibility study of the BALANCE intervention that is testing feasibility and acceptability of a intervention that includes individual and group sessions with a caregiver navigator. The focus of the intervention is the unmet needs of caregivers with disabilities.
干预措施: BALANCE Building Active LIving and Addressing Needs for Caregiver Empowerment (Behavioral)
结局指标
主要结局
Perceived Stress Scale
时间窗: Baseline and post intervention at approximately 10 weeks
Measurement of perceived stress. Scores can range from 0 to 40, with higher scores indicating worse levels of perceived stress.
Caregiver Burden Short Form
时间窗: Baseline and post intervention at approximately 10 weeks
Measure to address burdensome activities related to care giving experiences. Total score ranges from 0-48 wit higher scores indicating greater caregiver burden.
Depressive Symptoms (PHQ-9)
时间窗: Baseline and post intervention at approximately 10 weeks
Measure of depressive symptoms. Score range 0-27, higher values represent more depression symptoms
次要结局
未报告次要终点