Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05664945
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2022-12-09
Brief Title:
Rethinking Pulmonary Rehabilitation
Sponsor:
Copenhagen University Hospital Hvidovre
Organization:
Copenhagen University Hospital Hvidovre
Study Overview
Official Title:
Rethinking Pulmonary Rehabilitation for Patients With COPD a Three-arm Randomised Multicentre Trial REPORT-trial
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REPORT
Brief Summary:
Pulmonary rehabilitation PR is one of the cornerstones of care for people with COPD together with smoking cessation and medical treatment Despite the compelling evidence for its benefits pulmonary rehabilitation is delivered to less than 30 of patients with COPD Access to PR are particularly challenging and especially for those with the most progressed stages of the disease
Pulmonary Tele-rehabilitation PTR and Home-based pulmonary rehabilitation HPR are two emerging models using health-care supportive technology that have proven equivalent to the conventional PR programs in patients with COPD who are able and willing to participate in conventional PR
However much remain unknown regarding patients with COPD unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation No studies have been conducted to specifically intervene towards this group Response from emerging rehabilitation models for this specific group is a black box with no substantial research
To fulfill its potential of relevance results from emerging models such as Pulmonary Telerehabilitation and Home-based pulmonary rehabilitation must be of clinical relevance and superior to the current usual care medication and scheduled follow-up control in patients with COPD unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation
Pulmonary Tele-rehabilitation PTR and Home-based pulmonary rehabilitation HPR are two emerging models using health-care supportive technology that have proven equivalent to the conventional PR programs in patients with COPD who are able and willing to participate in conventional PR
However much remain unknown regarding patients with COPD unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation No studies have been conducted to specifically intervene towards this group Response from emerging rehabilitation models for this specific group is a black box with no substantial research
To fulfill its potential of relevance results from emerging models such as Pulmonary Telerehabilitation and Home-based pulmonary rehabilitation must be of clinical relevance and superior to the current usual care medication and scheduled follow-up control in patients with COPD unable to access and participate in the conventional out-patient hospital- or community-based PR when offered during routine consultation
Detailed Description:
This trial will investigate if pulmonary tele-rehabilitation PTR and home-based pulmonary rehabilitation HPR leads to respiratory symptom relief CAT score and improvements on secondary outcomes in patients unable to access conventional rehabilitation programs standard PR offer
Our hypotheses in a three-arm RCT design are
1 PTR and HPR will be equivalent to each other
2 PTR and HPR will be superior to usual care that is the control group CON - no intervention
Our hypotheses in a three-arm RCT design are
1 PTR and HPR will be equivalent to each other
2 PTR and HPR will be superior to usual care that is the control group CON - no intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None