Comprehensive Home-based Self-management Support for COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- COPD Assessment Test (CAT)
研究概览
简要总结
The study team will adapt and expand an effective model of asthma self-management support for patients with chronic obstructive pulmonary disease (COPD). In this new model, community health workers will comprehensively screen for and address barriers to effective COPD self-management, including maladaptive coping behaviors, and guide patients through home-based pulmonary rehabilitation. Feasibility of the new model will be assessed in preparation for a fully powered, multisite randomized trial.
详细描述
Phase II will focus on intervention implementation and evaluation (months 13-36).
The research team will randomize 58 COPD patients (29 per arm) to the SaMBA-COPD intervention or an attention control and follow them for 9 months to assess health and self-management behavior (SMB) outcomes.
Intervention:
Step 1: Outreach and Engagement. The project manager will notify the City Health Works (CHW) supervisor when an eligible and consented patient is randomized to receive care the intervention and will provide the patient's name and contact information. The CHW will call the patient within 7 days of consent to schedule a home visit. The CHW will encourage caregivers to join all meetings.
Step 2: Intake. The CHW will perform an intake interview that includes collection of basic information about the patient and their health and healthcare, including medications, intended to enable them to understand their health problems and provide them with chronic illness self-management support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Research coordinators (RCs) and investigators are blinded to study randomization and treatment arm for each participant.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >40 years
- •Chart-document severe or very severe COPD (FEV1<50% predicted) or COPD-related ED/hospitalization ≥ 1 visit within the past 12 months
- •Prescribed any daily medication for COPD, English or Spanish speaking, Smoking history ≥ 10 pack-years
排除标准
- •Diagnosis in the clinical record of dementia, because the study focuses on patients with capacity to independently perform self-management tasks.
结局指标
主要结局
COPD Assessment Test (CAT)
时间窗: Baseline and 6 months
The COPD Assessment Test (CAT) is a validated measure designed to measure the impact of COPD on a person's life, and how this changes over time. Full range from 0-40, higher scores indicates a more severe impact of COPD on a patient's life.
次要结局
- Number of Participants With Hospitalizations(Baseline and 6 months)
- Number of Participants With Medication Adherence Report Scale (MARS) Score ≥4.5(Baseline and 6 months)
- Exercise Tolerance - 6 Minute Walk Test(Baseline and 6 months)
- Physical Activity Adult Questionnaire (PAAQ)(Baseline and 6 months)
- Number of Participants With Controller Medication Adherence(Baseline and 6 months)
- Number of Participants With ED Visits(Baseline and 6 months)
研究者
Alex D Federman
Director of Research
Icahn School of Medicine at Mount Sinai