Post Discharge Online Telerehabilitation Program

Pain, Chronic Clinical Trial

— OTP  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03480620
• Other study ID #: BRCRC2017_001
• Status: Terminated
• Phase: N/A
• Start date: February 9, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2022
• Source: Brooks Rehabilitation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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?

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Chronic

Intervention

Other:
• Online Telerehabilitation Platform Access
Participants will have 24/7 access to a standardized set post-discharge exercise videos and self-management instructions across multiple internet connected devices (e.g. computer, tablet, smartphone). Standardized exercises include a flexibility routine that participants learned and performed with a physical therapist while in the pain management program. Self-management instructions are also written versions of concepts learned and practiced with a member of the multidisciplinary team during the pain management program.
• Usual care
Participants are given a DVD of the standardized post-discharge exercise videos and a written copy of the self-management instructions as described in the experimental group.

Locations

Country	Name	City	State
United States	Brooks Rehabilitation	Jacksonville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
Brooks Rehabilitation	Florida Physical Therapy Association, ReadyOp, Yoga, Fitness, Mindfulness

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program-Specific Outcomes Questionnaire	A 33-item questionnaire developed by the pain program to track post-discharge outcomes over time. This measure will be compared to the PROMIS measures to evaluate concurrent validity of the program-specific questionnaire.	12 months post discharge
Primary	Adherence to post-discharge home exercise recommendations	Self-reported home exercise program adherence. Utilization data from the online telerehabilitation platform will also be collected for the telerehabilitation group.	12 months post discharge
Primary	PROMIS Measure - Physical Function - Short Form 8b	PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands. A single Physical Function capability score is obtained from a short form. Each Physical Function instrument is appropriate for the adult general population and adults with chronic health conditions.	12 months post discharge
Primary	PROMIS Measure - Pain Interference - Short Form 4a	The PROMIS Pain Interference item banks assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life, though the item bank only contains one sleep item. The pain interference short forms are universal rather than disease-specific. All assess pain interference over the past seven days.	12 months post discharge
Primary	PROMIS Measure - Self-Efficacy for Managing Symptoms - Short Form 8a	Self-efficacy is defined as confidence in one's ability to successfully perform specific tasks or behaviors. Self-Efficacy for Managing Chronic Conditions assesses confidence in one's ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations. Several domains of Self-Efficacy for Managing Chronic Conditions relate to specific aspects of managing chronic conditions.; Self-Efficacy for Managing Chronic Conditions - Manage Symptoms: Confidence to manage/control their symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities.; The Self-Efficacy item banks are universal rather than disease-specific. The respondent should be an adult (age18+) and have at least one chronic health condition. The PROMIS Adult Self-Efficacy items banks have been modified from the NIH Toolbox Self-Efficacy item bank.	12 months post discharge
Primary	PROMIS Measure - Self-Efficacy for Managing Emotions - Short Form 8a	Self-efficacy is defined as confidence in one's ability to successfully perform specific tasks or behaviors. Self-Efficacy for Managing Chronic Conditions assesses confidence in one's ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations. Several domains of Self-Efficacy for Managing Chronic Conditions relate to specific aspects of managing chronic conditions.; Self-Efficacy for Managing Chronic Conditions - Manage Emotions: Confidence to manage/control symptoms of anxiety, depression, helplessness, discouragement, frustration, disappointment and anger.; The Self-Efficacy item banks are universal rather than disease-specific. The respondent should be an adult (age18+) and have at least one chronic health condition. The PROMIS Adult Self-Efficacy items banks have been modified from the NIH Toolbox Self-Efficacy item bank.	12 months post discharge
Secondary	Technology Acceptance Model Questionnaire	The Technology Acceptance Model (TAM) Questionnaire used in this study is a 23-item self report questionnaire investigating participants perceived usefulness (PU) and perceived-ease-of-use (PEOU) of the internet. Higher scores for PU and PEOU are purported to influence an individual's intention to use a particular technology.	12 months post discharge
Secondary	Patient Satisfaction	A single item rating satisfaction with home exercise and self-management program	12 months post discharge