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| Name | Class |
|---|---|
| Barzilai Medical Center | OTHER |
| International Respiratory Coalition (IRC) | UNKNOWN |
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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:
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:
A total of 90 participants meeting the study inclusion criteria will be randomized in a 1:1 ratio to either the intervention or control group. Randomization will be stratified by the participating centers. Within each stratum, treatment assignments will be determined using a computer-generated random allocation sequence utilizing variable block sizes of two or four. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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. | |
| Tele-Rehabilitation | Experimental | 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 5 participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-Rehabilitation | Other | 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 5 participants. The sessions include:
At the end of each session, every participant receives a personalized exercise plan based on their performance and preferences, which is displayed in the app. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to pulmonary rehabilitation Between the Study Groups | 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. | Assessed by a clinical research coordinator from enrollment to 6 months following study initiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation | Any safety events occurring during the Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation sessions (intervention/control group accordingly) or at the following 48 hours after. Safety events will be reported by the physiotherapist or treating physicians and assessed at every follow-up phone call. Each presumed safety event will be evaluated by the research team to decide about relevance and causality to the TPR/PR. Rates of safety events will be compared between the groups and will also be reported descriptively. Severity of adverse events will be determined based on the WHO International Classification for Patient Safety, and classified into mild (where no or minimal intervention were required), moderate (requiring treatment or permanent or long-term harm or loss of function) and (severe resulted in shortening of life expectancy or major permanent or long-term harm or loss of function). |
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Inclusion Criteria:
Patients meeting the Israeli Health Basket criteria for reimbursement of pulmonary rehabilitation (PR), including one of the following conditions:
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.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barzilai Medical Center | Ashkelon | Israel |
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| Label | URL |
|---|---|
| Pulmonary rehabilitation in bronchiectasis: a propensity-matched study | View source |
| Pulmonary Rehabilitation Is Associated With Decreased Exacerbation and Mortality in Patients With COPD: A Nationwide Korean Study | View source |
| Association Between Initiation of Pulmonary Rehabilitation After Hospitalization for COPD and 1-Year Survival Among Medicare Beneficiaries |
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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.
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| Assessed from enrollment to 6 months following study initiation. |
| Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate | Initiation rate of tele-pulmonary rehabilitation / traditional pulmonary rehabilitation. This will be defined as completion of at least one TPR / PR session. | Assessed by a clinical research coordinator from enrollment to 6 months following study initiation. |
| Global Evaluation of Treatment Effectiveness (GETE) score | Patient satisfaction with the tele-pulmonary rehabilitation \ traditional rehabilitation program assessed using the Global Evaluation of Treatment Effectiveness (GETE) scale. The GETE is a measure of perceived treatment effectiveness, with responses between 1 (Complete control of the disease following the treatment) to 5 (Worsening of the disease following the treatment). | Will be asked by the clinical research coordinator via phone call after 6 months following study initiation. |
| Respiratory Symptoms Burden Assessed by CAAT | Will be evaluated using the tools CAAT (Chronic Airways Assessment Test) eight question questionnaire on respiratory symptoms, confidence, sleep, and energy. The result is a score between 0-40. The score will be compared between the study groups. | Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation. |
| Health Care Utilization | Amount of times visited a physician, emergency department or hospitalization for acute respiratory symptoms. The mean amount per patient in each group will be compared between groups. | 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 | Will access by the Hospital Anxiety and Depression Score (HADS). HADS is a 14-items questionnaires that have been widely used in patients undergoing pulmonary rehabilitation to assess its affects. It consists of two subscales: HADS Anxiety (7 items) and HADS-Depression (7 items). Higher scores indicate worse condition. The scores will be compared between the study groups. | 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 | Will be base on the Lung Information Needs Questionnaire (LINQ) - a self-administered questionnaire that has 16 items, covering topics such as medication use, exercise, and exacerbation management. Scores range from 0 to 25, with higher score indicates a higher information needs. | Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 6 months following study initiation. |
| Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale | Will be evaluated using the tool mMRC (Modified Medical Research Council) Dyspnea Scale: a patient-reported tool used to assess the degree of baseline breathlessness related to physical activity. Scores are between 0 and 4, with higher scores indicating worse breathlessness. | 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. | Assessed by a clinical research coordinator from enrollment to 6 months following study initiation. |
| Adherence Rate Between The Study Groups | Adherence rate is actual number of sessions/total expected number of sessionĂ—100. The mean percentage will be compare between the groups. | Assessed by a clinical research coordinator from enrollment to 6 months following study initiation. |
| Adherence to pulmonary rehabilitation Between the Study Groups - long term | For this outcome, adherence will be defined as completion of at least 50% (12 sessions) of the program (regular/remote based on allocation) within 12 months from inclusion. | Assessed by a clinical research coordinator from enrollment to 12 months following study initiation. |
| Tele-pulmonary Rehabilitation / Traditional Pulmonary Rehabilitation Initiation Rate - long term | Initiation rate of tele-pulmonary rehabilitation / traditional pulmonary rehabilitation. This will be defined as completion of at least one TPR / PR session. | Assessed by a clinical research coordinator from enrollment to 12 months following study initiation. |
| Global Evaluation of Treatment Effectiveness (GETE) score - long term | Patient satisfaction with the tele-pulmonary rehabilitation \ traditional rehabilitation program assessed using the Global Evaluation of Treatment Effectiveness (GETE) scale. The GETE is a measure of perceived treatment effectiveness, with responses between 1 (Complete control of the disease following the treatment) to 5 (Worsening of the disease following the treatment). | Will be asked by the clinical research coordinator via phone call after 12 months following study initiation. |
| Respiratory Symptoms Burden Assessed by CAAT - long term | Will be evaluated using the tools CAAT (Chronic Airways Assessment Test) eight question questionnaire on respiratory symptoms, confidence, sleep, and energy. The result is a score between 0-40. The score will be compared between the study groups. | Assessed by a physician at baseline, and subsequent by the clinical research coordinator via phone call after 12 months following study initiation. |
| Health Care Utilization - long term | Amount of times visited a physician, emergency department or hospitalization for acute respiratory symptoms. The mean amount per patient in each group will be compared between groups. | 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 | Adherence rate is actual number of sessions/total expected number of sessionĂ—100. The mean percentage will be compared between the groups. | Assessed by a clinical research coordinator from enrollment to 12 months following study initiation. |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
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| View source |
| Pulmonary Rehabilitation Utilization in Older Adults with Chronic Obstructive Pulmonary Disease, 2013-2019 | View source |
| Participation in Pulmonary Rehabilitation after Hospitalization for Chronic Obstructive Pulmonary Disease among Medicare Beneficiaries | View source |
| The Need for Expanding Pulmonary Rehabilitation Services | View source |
| A blueprint for tele-rehabilitation guidelines | View source |
| The Long-Term Maintenance Effect of Remote Pulmonary Rehabilitation via Social Media in COPD: A Randomized Controlled Trial | View source |
| The Accessibility, Feasibility, and Safety of a Standardized Community-based Tele-Pulmonary Rehab Program for Chronic Obstructive Pulmonary Disease: A 3-Year Real-World Prospective Study | View source |
| Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial | View source |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D000081029 | Pulmonary Arterial Hypertension |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006976 | Hypertension, Pulmonary |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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