Pain, ChronicOTPNCT03480620
Post Discharge Online Telerehabilitation Program
A study testing Online Telerehabilitation Platform Access in people with Pain, Chronic, run by Brooks Rehabilitation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Online Telerehabilitation Platform Access
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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…
- …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.
- …achieve greater sustainability of programs outcomes including pain intensity, level of function, and reduction of opioid use.
Primary Research Questions
- Does access to an online telerehabilitation platform impact adherence to post-discharge home exercise recommendations in graduates from a comprehensive interdisciplinary pain rehabilitation program?
- 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
- 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.
- Utilization of the online telerehabilitation platform will be associated with perceptions of usefulness and ease of use of internet technology.
Secondary Research Questions
- Does use of an online telerehabilitation platform impact patient satisfaction with post-discharge self-management compared to current standard of care?
- Does internet technology acceptance impact utilization of post-discharge self-management resources provided through an online telerehabilitation platform?
- Conditions
- Pain, Chronic
- Being tested
- Online Telerehabilitation Platform Access, Usual care
- Keywords
- Telehealth, Telerehabilitation, Chronic pain, Post-discharge care
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Telerehabilitation Platform AccessOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months post discharge
Secondary outcomes (2)
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.
Measured: 12 months post discharge
Patient Satisfaction
A single item rating satisfaction with home exercise and self-management program
Measured: 12 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start9 Feb 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooks Rehabilitation
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Physical Therapy Association, Yoga, Fitness, Mindfulness, ReadyOp
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480620
- Sponsor's protocol ID
- BRCRC2017_001
- Acronym
- OTP
- Status last verified
- Dec 2022
- First submitted
- 2 Feb 2018
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03480620
- Acronym / sponsor ID
- OTP / BRCRC2017_001
- Conditions
- Pain, Chronic
- Keywords
- Telehealth, Telerehabilitation, Chronic pain, Post-discharge care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Brooks RehabilitationUniversity, hospital or other
- Collaborators
- Florida Physical Therapy Association, Yoga, Fitness, Mindfulness, ReadyOp
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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…
- …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.
- …achieve greater sustainability of programs outcomes including pain intensity, level of function, and reduction of opioid use.
Primary Research Questions
- Does access to an online telerehabilitation platform impact adherence to post-discharge home exercise recommendations in graduates from a comprehensive interdisciplinary pain rehabilitation program?
- 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
- 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.
- Utilization of the online telerehabilitation platform will be associated with perceptions of usefulness and ease of use of internet technology.
Secondary Research Questions
- Does use of an online telerehabilitation platform impact patient satisfaction with post-discharge self-management compared to current standard of care?
- Does internet technology acceptance impact utilization of post-discharge self-management resources provided through an online telerehabilitation platform?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: Online Telerehabilitation Platform AccessParticipant 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. |
| Usual care | Active comparator | Other: Usual careParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Telerehabilitation Platform AccessParticipants 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. | Other | Telerehabilitation |
| Usual careParticipants 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. | Other | Usual care |
Primary outcome
Adherence to post-discharge home exercise recommendations
Time frame: 12 months post discharge
Self-reported home exercise program adherence. Utilization data from the online telerehabilitation platform will also be collected for the telerehabilitation group.
PROMIS Measure - Physical Function - Short Form 8b
Time frame: 12 months post discharge
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.
PROMIS Measure - Pain Interference - Short Form 4a
Time frame: 12 months post discharge
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.
PROMIS Measure - Self-Efficacy for Managing Symptoms - Short Form 8a
Time frame: 12 months post discharge
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.
PROMIS Measure - Self-Efficacy for Managing Emotions - Short Form 8a
Time frame: 12 months post discharge
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.
2 secondary outcomes
Technology Acceptance Model Questionnaire
Time frame: 12 months post discharge
Patient Satisfaction
Time frame: 12 months post discharge
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Telerehabilitation Platform Access in people with Pain, Chronic, run by Brooks Rehabilitation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to post-discharge home exercise recommendations (time frame: 12 months post discharge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.