NCT03409653Enrolling By Invitation不适用
Complex Chronic Diseases Program Data Registry
BC Women's Hospital & Health Centre1 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2017年6月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,300
- 试验地点
- 1
- 主要终点
- Change in quality of life
研究概览
简要总结
The purpose of this data registry is to prospectively collect data from patients referred to an Complex Chronic Diseases Program (CCDP) at BC Women's Hospital + Health Centre to assess the quality of life of the CCDP Patients before, during and after their care at the CCDP.
详细描述
- Before their initial intake appointment, all CCDP patients are given a patient binder that includes the baseline Standardized Questionnaires. These are clinical questionnaires that all patients complete regardless of whether or not they consent to participation in research. In addition to the questionnaires completed at baseline, patients who consent to participate in the data registry will complete the questionnaires, via email or paper copy, at the following time points: approximately 6 months after intake, at discharge and 3 months post-discharge.
- Patients who consent to the data registry will also be asked to complete a short questionnaire collecting basic demographic information at baseline. The demographic questionnaire will be either mailed to their home or sent via an online link; the investigators will ask participants to complete this form either before or when they come in for their first in-person visit at the CCDP.
- Additional data will be collected and entered from the clinical chart. Specifically, after the patient's initial clinic appointment, the Research Coordinator or designate will enter data points from the Interdisciplinary Assessment Tool, into REDCap.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Newly referred patients of the Complex Chronic Diseases Program
- •Must be able to read and understand English
- •18 years of age or older
排除标准
- •Have not completed the Standardized Questionnaires booklet prior to the initial intake assessment.
结局指标
主要结局
Change in quality of life
时间窗: Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge
Change in self-reported quality of life assessed by structured questionnaire (36 Item Short Form Health Survey (SF-36))
次要结局
- Fatigue Severity Scale (FSS)(Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge)
- McGill Pain Questionnaire Short Form(Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge)
- Brief Pain Inventory Short Form (BPI-SF)(Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge)
- Patient Health Questionnaire 9 (PHQ - 9)(Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge)
- Generalized Anxiety Disorder - 7 item (GAD - 7)(Baseline (pre-intake), 6 months, discharge (an average of 21 months), 3 months post-discharge)
研究者
Luis Nacul
Medical Director CCDP, Complex Chronic Care Clinic
BC Women's Hospital & Health Centre
研究点 (1)
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