Tele-Pulmonary Rehabilitation For COPD Patients Living in Peripheral Areas

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:

A total of 110 participants meeting the study inclusion criteria will be randomized in a 1:1 ratio to either the intervention or control group. Treatment assignments will be determined using a computer-generated random allocation sequence. To prevent selection bias and maintain strict allocation concealment, the randomization schedule will be generated and housed within a secure, centralized electronic system managed exclusively by an independent study coordinator. The clinical research team, including investigators responsible for patient enrollment and clinical care, will remain entirely removed from sequence generation and block determination. Allocation will be revealed sequentially on a patient-by-patient basis only after a participant's eligibility is confirmed and the index visit disposition is finalized.

Patient inclusion - A call for participation will be advertised in different media sources for potential participants. Following a phone call for initial screening, the research team will perform the screening and randomization visit in adjacent to the patient living area or at the study center.

For the study, periphery was defined as geographic periphery, given the scarcity of pulmonary rehabilitation centers in those areas. Geographic periphery was defined as residing in localities classified within clusters 1 to 5 on the official Peripherality Index developed by the Israeli Central Bureau of Statistics (CBS) (where 1 represents the highest level of peripheral isolation and 10 the most central). Utilizing this strict, government-validated cutoff ensures the construct validity of our study.

• Safety of Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation [Time frame: Assessed from enrollment to 6 months following study initiation.]
• Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate [Time frame: Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.]
• Respiratory Symptoms Burden Assessed by CAT [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Will be asked by the clinical research coordinator via phone call after 6 months following study initiation.]
• Adherence Rate Between The Study Groups [Time frame: Assessed by a clinical research coordinator from enrollment to 6 months following study initiation.]
• Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale [Time frame: 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 frame: 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 [Time frame: Assessed by a clinical research coordinator from enrollment to 12 months following study initiation.]