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NCT07666854
Tele-Pulmonary Rehabilitation For COPD Patients Living in Peripheral Areas
Conditions: COPD (Chronic Obstructive Pulmonary Disease), Rehabilitation, Peripheral
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 110
Sponsor: Tel-Aviv Sourasky Medical Center
Location: Tel Aviv Sourasky Medical Center Tel Aviv
Summary
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).
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07666854). StuddyBuddy aggregates publicly available trial information.