Examining the Feasibility and Effectiveness of a Remote Group Respiratory Rehabilitation Program for Patients With Chronic Obstructive Pulmonary Disease Living in Peripheral Areas as a First Step to Policy Change
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Adherence to pulmonary rehabilitation Between the Study Groups
研究概览
简要总结
Pulmonary rehabilitation (PR) is a key non-pharmacological intervention for patients with chronic obstructive pulmonary disease (COPD), yet it remains underutilized, particularly among patients living in peripheral areas due to limited access, travel distance, and logistical barriers. Tele-pulmonary rehabilitation (TPR) has the potential to improve access to care, but its feasibility and effectiveness as a group-based intervention have not been well established.
The aim of this study is to evaluate whether a group-based TPR program can improve treatment initiation and adherence compared to usual care, defined as referral to standard PR, among COPD patients living in peripheral areas. In addition, the study will assess the effect of the intervention on COPD exacerbations, symptom burden, quality of life, and patient satisfaction.
This is a prospective randomized controlled trial that will enroll patients with COPD who are eligible for PR according to the Israeli health basket criteria and have not participated in PR in the past year. Participants will be randomly assigned to one of two groups: (1) referral to standard PR (control group), or (2) participation in a 12-week, twice-weekly, group-based TPR program delivered remotely via a dedicated application and video sessions (intervention group).
详细描述
Data collection:
Participants will be followed for 12 months after enrollment. Baseline data will include demographic characteristics, medical history and pulmonary function tests. Follow-up phone calls will be conducted at 1.5, 3, and 6 months to assess initiation of pulmonary rehabilitation, adherence, safety events, symptoms, COPD exacerbations, FEV1 and the 1MSTS and healthcare utilization. An additional follow-up assessment will be conducted at 12 months after enrollment. Patient-reported outcomes will include respiratory symptom burden assessed using the COPD assessment test (CAT), health-related quality of life assessed using the St. George's Respiratory Questionnaire (SGRQ), anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS), knowledge assessed using the Lung Information Needs Questionnaire (LINQ), and patient satisfaction assessed using the Global Evaluation of Treatment Effectiveness (GETE). Adherence to tele-pulmonary rehabilitation will also be monitored using participation logs from the rehabilitation sessions.
Sample Size Calculation:
Based on prior studies and available data in Israel, adherence to pulmonary rehabilitation is expected to be approximately 40% in the control group. We hypothesize that participation in a group tele-pulmonary rehabilitation (TPR) program will increase adherence to 75%. To detect this difference with a power of 80% and a significance level of 0.01, 45 participants are required in each group. Assuming a 15-20% loss to follow-up, the total planned sample size is 110 participants (55 participants per group).
Randomization:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All outcomes will be assessed at similar time frames for both the intervention and control groups and filled in an identical form. All phone calls to assess the study outcomes will be performed by research assistances blinded to group allocation. All forms from each phone call will be stored in a single sealed box without details on group allocation. The data extraction from the forms for the study database will be performed at the end of the study by research assistants who will be blinded to group allocation. Statistical analysis will also be done by masking group allocation.
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
- •Male and females Patients with COPD based on accepted criteria who are eligible for reimbursement of pulmonary rehabilitation (PR) according to the Israeli "health basket" criteria including one of the following:
- •FEV1 below 50%
- •Severe exacerbation (hospitalization) in the previous year
- •Two moderate exacerbations in the previous year
- •Willingness to initiate a PR or TPR programs.
- •Living in geographic peripheral area.
- •Ability to perform the TPR program or traditional PR activities as assessed by a member of the study team prior to enrollment.
- •Agree to participate, with signed informed consent.
- •Age > 18.
排除标准
- •Uncontrolled comorbidity (e.g uncontrolled congestive heart failure).
- •Inability to operate the mobile application.
- •Without a mobile device or computer.
- •An exacerbation in the 2-months prior to randomization.
- •Completed PR program in the last 12 months.
- •Pregnancy.
- •Patients with cognitive impairment.
研究组 & 干预措施
Tele-Rehabilitation
Participants will undergo a 12 weeks tele-rehabilitation program using a dedicated application. The intervention consists of 24 online sessions (twice weekly) led by a senior respiratory physiotherapist in groups of up to 4-6 participants.
干预措施: Tele-Rehabilitation (Other)
Control
Participants in the control group will be sent back to their referring physicians with a recommendation to initiate pulmonary rehabilitation as soon as possible, signed by a pulmonologist. The treating physicians will also be notified.
结局指标
主要结局
Adherence to pulmonary rehabilitation Between the Study Groups
时间窗: Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.
Adherence will be defined as initiation of pulmonary rehabilitation in 3 months from study inclusion and completion of at least 50% (12 sessions) of the program (regular/remote based on allocation) within 6 months from inclusion.
次要结局
- Safety of Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation(Assessed from enrollment to 6 months following study initiation.)
- Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate(Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.)
- Respiratory Symptoms Burden Assessed by CAT(Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.)
- Number of Moderate and Severe COPD Exacerbations (6 months)(Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.)
- Health-related Quality of Life Assessed by SGRQ (6 months)(Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.)
- Anxiety and Depression Assessed by HADS(Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.)
- Change in Patient Knowledge and Information Needs(Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.)
- Global Evaluation of Treatment Effectiveness (GETE) score(Will be asked by the clinical research coordinator via phone call after 6 months following study initiation.)
- Adherence Rate Between The Study Groups(Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.)
- Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale(Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation.)
- Time to Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation(Time to initiation of tele-pulmonary rehabilitation / traditional pulmonary rehabilitation. This will be defined as time from study inclusion to first TPR / PR session.)
- Adherence to pulmonary rehabilitation Between the Study Groups - long term(Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.)
- Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale - long term(Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 12 months following study initiation.)
- Adherence Rate Between The Study Groups - long term(Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.)
- Global Evaluation of Treatment Effectiveness (GETE) score - long term(Will be asked by the clinical research coordinator via phone call after 12 months following study initiation.)
- Number of Moderate and Severe COPD Exacerbations - long term(Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 12 months following study initiation.)
- Respiratory Symptoms Burden Assessed by CAT - long term(Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 12 months following study initiation.)
- Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate - long term(Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.)