INCLUDE Program: A Perioperative Wellness Program Tailored for Black Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reach of the study as measured by number of patients who agree to participate in the study out of total eligible to participate
研究概览
简要总结
In this study, the investigators will evaluate the feasibility of the Wellness Program, including patient recruitment, screening and outcome measures, and feasibility of adapting the intervention with older Black surgical patients who endorse clinically significant symptoms of depression and/or anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years
- •Scheduled surgical procedure at BJH or BJWCH (oncologic, cardiac; orthopedic)
- •Clinically significant depression or anxiety symptoms screened by the PHQ-ADS (Patient Health Questionnaire Anxiety and Depression Scale) ≥10
- •Black or African American.
排除标准
- •Inability to provide informed consent;
- •Severe cognitive impairment screened by the SBT (Short Blessed Test) ≥10
- •Acutely suicidal
- •Considered ineligible per the discretion of the surgeon or study PI
- •Considered ineligible per the discretion of the surgeon or study PI
- •Caregiver participants:
- •If patients identify a caregiver that the patient would like to include in their Wellness Program, the caregiver will be invited to consent. Patients will provide contact information for their caregiver.
结局指标
主要结局
Reach of the study as measured by number of patients who agree to participate in the study out of total eligible to participate
时间窗: Through completion of enrollment for all participants (estimated to be 9 months, time for participant 1 day)
Reach of the intervention as measured by number of patients who completed the intervention out of patients who agreed to participate in the study
时间窗: Through completion of follow-up for all participants (estimated to be 12 months, time for participant 3 months)
次要结局
- Percentage of instrument or data fields completed for Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS)(Baseline, 1 month after surgery, and 3 months after surgery)