Post Discharge Online Telerehabilitation Program

NCT ID: NCT03480620

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-09

Study Completion Date

2019-12-31

Brief Summary

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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

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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?

Conditions

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Pain, Chronic

Keywords

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Telehealth Telerehabilitation Chronic pain Post-discharge care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Telerehabilitation

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.

Group Type EXPERIMENTAL

Online Telerehabilitation Platform Access

Intervention Type 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.

Usual care

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.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida Physical Therapy Association

UNKNOWN

Sponsor Role collaborator

Yoga, Fitness, Mindfulness

UNKNOWN

Sponsor Role collaborator

ReadyOp

UNKNOWN

Sponsor Role collaborator

Brooks Rehabilitation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Brooks Rehabilitation

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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BRCRC2017_001

Identifier Type: -

Identifier Source: org_study_id