Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390345
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-04-25
Brief Title:
Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention
Sponsor:
Seattle Institute for Biomedical and Clinical Research
Organization:
Seattle Institute for Biomedical and Clinical Research
Study Overview
Official Title:
Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention
Status:
RECRUITING
Status Verified Date:
2024-07
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:
FOCuSEd
Brief Summary:
The investigators will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with Chronic Obstructive Pulmonary Disease COPD and Obstructive Sleep Apnea OSA The investigators will include eligible participants receiving primary care at one of five Department of Veterans Affairs VA medical centers and their community-based outpatient clinics The investigators will randomize patients in a 11 ratio to the multi-component intervention or enhanced usual care stratifying by age 65 vs 65 and site Participants randomized to the intervention will receive an integrated telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation At the end of 3 months the investigators will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants In the post-core period months 4-12 participants will continue to have as-needed access to the lifestyle coach For participants randomized to the enhanced usual care group study staff will prompt the patients primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs Follow-up will occur at virtual visits at 3 and 12 months The primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score Secondary effectiveness outcomes will include other measures of quality of life including sleep related impairment sleep disturbance disease severity COPD exacerbations and respiratory event index for OSA depression social support weight loss and cardiovascular risk In addition to assessing effectiveness investigators will also conduct a concurrent implementation process evaluation using the RE-AIM framework
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| TE-2022C3-30598 | OTHER_GRANT | Patient-Centered Outcomes Research Institute PCORI | None |