Tele-Pulmonary Rehabilitation to Improve Adherence and Management of Patients With Chronic Lung Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 2
研究概览
简要总结
Pulmonary rehabilitation is a key treatment for lung diseases, but many patients struggle to attend sessions due to travel distances, physical limitations, or logistical barriers. The purpose of this study is to evaluate whether a tele-pulmonary rehabilitation (TPR) program can improve the rates of treatment initiation and adherence among patients with chronic lung diseases compared to traditional, center-based pulmonary rehabilitation. Additionally, the study will assess improvements in quality of life, physical symptoms, and safety in both groups.
This study will enroll 90 patients from two medical centers in Israel (Tel Aviv and Barzilai). Participants will be randomly assigned to one of two groups:
- The control group will receive usual care with a referral by a pulmonologist to standard pulmonary rehabilitation at a medical center.
- The intervention group will participate in a supervised remote tele-rehabilitation program using a dedicated application and remote monitoring.
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 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 Chronic Airways Assessment Test (CAAT), 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, adherence to pulmonary rehabilitation is expected to be approximately 33% in the control group. The researchers hypothesize that tele-pulmonary rehabilitation will increase adherence to 66%. To detect this difference with a power of 80% and a significance level of 0.01, 35 participants are required in each group. Assuming a 20-25% loss of follow up, the total planned sample size is 90 participants (45 patients 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting the Israeli Health Basket criteria for reimbursement of pulmonary rehabilitation (PR), including one of the following conditions:
- •COPD with an FEV1 below 50% or with severe exacerbation (hospitalization) in the previous year or two moderate exacerbations in the previous year.
- •Interstitial lung disease with an FVC below 80% or a DLCO below 60%.
- •Bronchiectasis with at least two exacerbations in the past year or at least one hospitalization, and an FEV1 below 80%.
- •Pulmonary arterial hypertension.
- •Willingness to initiate a PR or Tele-PR (TPR) programs.
- •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.
排除标准
- •Uncontrolled comorbidity (e.g uncontrolled congestive heart failure)
- •Inability to operate the mobile application.
- •Without a mobile device or computer.
- •A hospitalization in the 2-months prior to randomization.
- •Completed PR program in the last 12 months.
- •Inability to complete 10 repetitions in the 1-minute sit-to-stand test or 5-second single-leg stance
- •Inability to provide informed consent due to impaired decision-making capacity, as determined by the study's capacity assessment.