Post Discharge Online Telerehabilitation Program

NCT03480620 | Terminated

• 1 other identifier: BRCRC2017_001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain, Chronic

Keywords

Telehealth; Telerehabilitation; Chronic pain; Post-discharge care

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Technology Acceptance Model Questionnaire

  12 months post discharge

• Patient Satisfaction

  12 months post discharge

Other Outcomes (1)

• Program-Specific Outcomes Questionnaire

  12 months post discharge

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

Participant randomized into the telerehabilitation group will receive verbal and written discharge recommendations from each member of the team as usual. They will also be given a login to the online telerehabilitation platform where they will find the designated flexibility routines which can be accessed from a computer, tablet/slate, or smart phone at any time. Participant will receive electronic reminders via email and/or text message to perform their home program and complete the follow up questionnaires. Other physical therapy exercises may be recommended based on individual patient's need. These exercises will be provided in verbal and written form.

Other: Online Telerehabilitation Platform Access

Usual care

ACTIVE COMPARATOR

Participants randomized into the usual care group will receive verbal and written discharge recommendations from each member of the team as usual. They will be provided with a copy of the DVD and instructed to practice one of the two routines at least 5 days per week. They will also be given a login to the online platform but will only have access to complete the follow up questionnaires. Participant will receive electronic reminders via email and/or text message to complete the follow up questionnaires. Other physical therapy exercises may be recommended based on individual patient's need. These exercises will be provided in verbal and written form.

Other: Usual care

Interventions

Online Telerehabilitation Platform Access OTHER

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.

Telerehabilitation

Usual care OTHER

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.

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brooks Rehabilitation: lead
• Florida Physical Therapy Association: collaborator
• Yoga, Fitness, Mindfulness: collaborator
• ReadyOp: collaborator

Study Sites (1)

Brooks Rehabilitation

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: March 29, 2018
• Study Start: February 9, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

US (1)