Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471920
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-18
Brief Title:
Improving Health for Patients With Chronic LBP in Rural Communities Through Telerehabilitation
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
ARBOR Telehealth Improving Health for Patients With Chronic Low Back Pain in Rural Communities Through Improved Access to Telerehabilitation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
ARBOR-Th
Brief Summary:
Physical therapy is the first line of treatment for patients with low back pain LBP and has been shown to be a cost-effective method for improving pain and disability in patients with chronic LBP however despite this effectiveness only 7-13 of patients go on to receive physical therapy services with patients in rural communities being especially limited to do lack of provider availability transportation and missed work time leading to greater rates of LBP-related disability and opioid consumption With the rapid emergence of digital treatment approaches to physical therapy ie telerehabilitation access could be improved by reducing or eliminating many barriers that patients report however it is unclear how to appropriately incorporate digital treatment approaches into existing health care models The investigators propose a single-masked prospective randomized clinical trial conducted at a health system serving rural communities to determine the effectiveness of innovative risk-stratified telerehabilitation versus standard educational control for patients with chronic LBP that will match individual patients with specific physical therapy delivery physical therapy telehealth visits or psychologically informed physical therapy telehealth visits based on the patients psychosocial risk of poor outcomes
Detailed Description:
Chronic low back pain LBP imposes tremendous burden on affected individuals healthcare systems and society LBP has been identified as the most common cause of disability globally and in the United States US LBP is also the largest driver of US healthcare spending 135 billion in 2016 and the most common diagnoses associated with opioid prescription and consumption For patients with chronic LBP physical therapy has been shown to be a cost-effective method for improving pain and disability In addition physical therapy has been shown to decrease the risk of advanced imaging injections surgery and opioid use in patients with chronic LBP
Despite available evidence in support only 7-13 of patients with LBP including those with chronic LBP go on to receive physical therapy services with patients reporting barriers accessing physical therapy such as transportation provider availability and missed work time Access is especially limited in rural communities where there are approximately 40 fewer physical therapists available per capita compared to metropolitan regions In addition patients living in rural communities likely need to travel longer distances to receive physical therapy requiring additional missed work time and transportation costs This lack of access to physical therapy in rural communities likely contributes to the greater rates of LBP-related disability and opioid consumption that have been observed in rural communities compared to metropolitan areas Innovative methods for improving access to physical therapy are urgently needed to address disparities in outcomes for patients with chronic LBP living in rural communities in the US Telehealth has rapidly expanded during the COVID-19 pandemic This includes policy changes that have allowed physical therapists to begin providing care remotely also referred to as telerehabilitation Telerehabilitation stands to improve access to physical therapy for patients with chronic LBP living in rural communities and may serve as a means of improving outcomes of these patients
The investigators will conduct a single-blind prospective randomized clinical trial addressing key questions to understanding the effectiveness of a risk-informed telerehabilitation to reduce opioid use and LBP-related disability and to improve physical function and health-related quality of life HRQoL in patients with chronic LBP Additionally the investigators will explore implementation outcomes using a mixed methods approach consisting of electronic surveys and semi-structured interviews with patients physical therapists practice managers and outpatient services administration focusing on perceived quality and impact on barriers to care The investigators will enroll 434 patients with LBP presenting to primary care clinics serving rural communities TidalHealth Salisbury MD Eligible patients will provide informed consent and be randomized to either an educational control or risk-informed telerehabilitation physical therapy telehealth visits or informed physical therapy telehealth visits Primary effectiveness outcome is difference in change in LBP-related disability Oswestry Disability Index and in opioid use after 8 weeks of treatment
Despite available evidence in support only 7-13 of patients with LBP including those with chronic LBP go on to receive physical therapy services with patients reporting barriers accessing physical therapy such as transportation provider availability and missed work time Access is especially limited in rural communities where there are approximately 40 fewer physical therapists available per capita compared to metropolitan regions In addition patients living in rural communities likely need to travel longer distances to receive physical therapy requiring additional missed work time and transportation costs This lack of access to physical therapy in rural communities likely contributes to the greater rates of LBP-related disability and opioid consumption that have been observed in rural communities compared to metropolitan areas Innovative methods for improving access to physical therapy are urgently needed to address disparities in outcomes for patients with chronic LBP living in rural communities in the US Telehealth has rapidly expanded during the COVID-19 pandemic This includes policy changes that have allowed physical therapists to begin providing care remotely also referred to as telerehabilitation Telerehabilitation stands to improve access to physical therapy for patients with chronic LBP living in rural communities and may serve as a means of improving outcomes of these patients
The investigators will conduct a single-blind prospective randomized clinical trial addressing key questions to understanding the effectiveness of a risk-informed telerehabilitation to reduce opioid use and LBP-related disability and to improve physical function and health-related quality of life HRQoL in patients with chronic LBP Additionally the investigators will explore implementation outcomes using a mixed methods approach consisting of electronic surveys and semi-structured interviews with patients physical therapists practice managers and outpatient services administration focusing on perceived quality and impact on barriers to care The investigators will enroll 434 patients with LBP presenting to primary care clinics serving rural communities TidalHealth Salisbury MD Eligible patients will provide informed consent and be randomized to either an educational control or risk-informed telerehabilitation physical therapy telehealth visits or informed physical therapy telehealth visits Primary effectiveness outcome is difference in change in LBP-related disability Oswestry Disability Index and in opioid use after 8 weeks of treatment
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 |
|---|---|---|---|
| UG3AR083838 | NIH | None | None |