Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Israel National Institute For Health Policy Research | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 4-6 participants. |
|
| 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. |
| 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 6 participants. The sessions include: 1) Supervised Exercise: Aerobic and resistance training using household items, stretching, and breathing techniques. 2) Remote Monitoring: Vital signs (heart rate and oxygen saturation) monitored every 10-15 minutes via a study-provided pulse oximeter. 3) Comprehensive Education: Guidance on lifestyle, nutrition, and physical activity. 4) Digital Support: The app provides activity tracking, symptom logging, session reminders, and guided home exercises. 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). |
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Tel Aviv | 6423906 | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
|
|
| 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. Rates will be compared between the study groups. | Assessed by a clinical research coordinator from enrollment to 6 months following study initiation. |
| Respiratory Symptoms Burden Assessed by CAT | Will be evaluated using the COPD Assessment Test (CAT), an eight items patient-administered questionnaire assessing respiratory symptoms, confidence, sleep, and energy levels. The total score ranges from 0 to 40, with higher scores indicating greater symptom burden. 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. |
| Number of Moderate and Severe COPD Exacerbations (6 months) | The number of moderate and severe COPD exacerbations will be assessed over the 6 months following study enrollment. Moderate exacerbations are defined as events requiring treatment with systemic corticosteroids, antibiotics, or both. Severe exacerbations are defined as events leading to hospitalization, emergency medical care visits, or death. The mean rate will be compared between the groups. | 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) | The St. George's Respiratory Questionnaire (SGRQ) is comprised of 16 questions or sections that address topics such as frequency of symptoms, current activity, and mood. Lower scores indicate a better health related quality of life. The tool has been validated by multiple studies for COPD and correlate with other objective outcomes. | 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 be assessed 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 based 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. |
| 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. |
| Adherence Rate Between The Study Groups | Adherence rate is actual number of sessions/total expected number of session×100. The mean percentage will be compare between the groups. | Assessed by a clinical research coordinator from enrollment to 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 | Assessed by a clinical research coordinator from enrollment to 6 months following study 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 | 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. |
| Respiratory Symptoms Burden Assessed by mMRC Dyspnea Scale - long term | 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 12 months following study initiation. |
| Adherence Rate Between The Study Groups - long term | Adherence rate is actual number of sessions/total expected number of session×100. The mean percentage will be compare between the groups. | 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. |
| Number of Moderate and Severe COPD Exacerbations - long term | The number of moderate and severe COPD exacerbations will be assessed over the 12 months following study enrollment. Moderate exacerbations are defined as events requiring treatment with systemic corticosteroids, antibiotics, or both. Severe exacerbations are defined as events leading to hospitalization, emergency medical care visits, or death. The mean rate will be compared between the groups. | 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 | Will be evaluated using the COPD Assessment Test (CAT), an eight items patient-administered questionnaire assessing respiratory symptoms, confidence, sleep, and energy levels. The total score ranges from 0 to 40, with higher scores indicating greater symptom burden. 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. |
| 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. Rates will be compared between the study groups. | Assessed by a clinical research coordinator from enrollment to 12 months following study initiation. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |