Clinical trial NCT03480620: Post Discharge Online Telerehabilitation Program
Official title: Access to an Online Telerehabilitation Exercise Program Post-discharge From a Comprehensive Pain Management Program: Patient Acceptance and Impact on Outcomes Sustainability and Return to Opioid Use
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Chronic
Keywords: Telehealth
Telerehabilitation
Chronic pain
Post-discharge care
Lead sponsor: Brooks Rehabilitation
Sponsor class: OTHER
Collaborators: name: Florida Physical Therapy Association
name: Yoga, Fitness, Mindfulness
name: ReadyOp
First posted: 2018-03-29
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A stratified random sampling approach will be used for this study whereby graduates from the BPRP will first be identified as having weaned off opioid medications (weaners) or did not wean off opioid medication (non-weaners). Once stratified into these two groups, participants will then be randomly assigned to either the standard care group (control group) or the telerehabilitation group (intervention group) based on sequential enrollment into each study group. Participants will continue with there post-discharge exercise and self-management program for one year, completing follow up assessment using the online platform at 1, 3, 6, 9, and 12 months post discharge.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will evaluate the sustainability of pain and functional outcomes along with return to opioid use in a population of patients that successfully completed a comprehensive interdisciplinary pain rehabilitation program. In addition, this study will compare outcomes sustainability and return to opioid use between pain program graduates who receive post discharge self-management resources consisting of a DVD with videos of recommended flexibility practice (standard of care) or access to an online telerehabilitation platform that provides patients with access to the flexibility practice videos on a variety of telecommunication devices (e.g., computer, smart phone, tablet).

Detailed description: The primary purpose of this paper is to compare the use of an online telerehabilitation platform versus a standard prerecorded DVD in supporting the sustainability of outcomes achieved during a comprehensive multidisciplinary pain rehabilitation program.

Primary Hypotheses Graduates from a comprehensive interdisciplinary pain rehabilitation program will...

1. ...demonstrate greater adherence to post-discharge home exercise recommendations when given access to an online telerehabilitation platform compared to DVDs offered as current standard of care.
2. ...achieve greater sustainability of programs outcomes including pain intensity, level of function, and reduction of opioid use.

Primary Research Questions

1. Does access to an online telerehabilitation platform impact adherence to post-discharge home exercise recommendations in graduates from a comprehensive interdisciplinary pain rehabilitation program?
2. Does access to an online telerehabilitation platform impact outcomes sustainability and opioid use in graduates from a comprehensive interdisciplinary pain management program?

Additional items that will be evaluated by this study include the participants' experience and satisfaction with use of the online telerehabilitation platform.

Secondary Hypotheses

1. Participants using the online telerehabilitation platform will report a more enjoyable experience and overall greater satisfaction with post-discharge self-management compared to participants receiving standard of care.
2. Utilization of the online telerehabilitation platform will be associated with perceptions of usefulness and ease of use of internet technology.

Secondary Research Questions

1. Does use of an online telerehabilitation platform impact patient satisfaction with post-discharge self-management compared to current standard of care?
2. Does internet technology acceptance impact utilization of post-discharge self-management resources provided through an online telerehabilitation platform?

Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic pain consistent with IASP definition.
* Classification as a "completer" of the Brooks Rehabilitation Pain Rehabilitation Program by attending the expected number of sessions and achieving at least 90% of goals.
* Able to read, write, and understand spoken English fluently.

Exclusion Criteria:

* Any medical condition that would place the participant at risk with performing a home exercise program.
* Inability to see or hear the audio visual device from a distance of at least 5 feet (may use headphones).
* Cognitive impairment or learning barriers preventing appropriate ability to access and navigate the study-related web-site or play the study-related DVD's.
* Lack of regular access to internet service.
* Lack of regular access to an internet connected audio-visual device (e.g., smartphone, computer, tablet, etc) in a location with sufficient space to perform exercises.
* Not familiar with basic internet navigation (i.e. able to locate and access a desired website and use basic within-site navigation tools such as scrolling and clicking on links.
* Currently pregnant (self-reported)

Primary outcomes:
measure: Adherence to post-discharge home exercise recommendations
timeFrame: 12 months post discharge
measure: PROMIS Measure - Physical Function - Short Form 8b
timeFrame: 12 months post discharge
measure: PROMIS Measure - Pain Interference - Short Form 4a
timeFrame: 12 months post discharge
measure: PROMIS Measure - Self-Efficacy for Managing Symptoms - Short Form 8a
timeFrame: 12 months post discharge
measure: PROMIS Measure - Self-Efficacy for Managing Emotions - Short Form 8a
timeFrame: 12 months post discharge
Secondary outcomes:
measure: Technology Acceptance Model Questionnaire
timeFrame: 12 months post discharge
measure: Patient Satisfaction
timeFrame: 12 months post discharge
Other outcomes:
measure: Program-Specific Outcomes Questionnaire
timeFrame: 12 months post discharge
Locations:
city: Jacksonville
country: United States
facility: Brooks Rehabilitation
state: Florida
Study officials:
References: