Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484751
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-26
Brief Title:
Alberta Rehabilitation Advice Line SelfBack Study
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Alberta Rehabilitation Advice Line SelfBack Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recurrent and persistent low back pain LBP is a massive problem in Canada that causes a substantial pain disability cost and even premature death
The good news is that treatments for recurrent and persistent LBP are available Many guidelines now recommend education and exercise as the best intervention for chronic LBP Unfortunately education and exercise programs are not publicly funded in Canada-only Canadians with extended health benefits can access these programs
As a result the 50 of Canadians who do not have extended health benefits often seek care for LBP from their publicly funded physicians Physicians in turn have little choice but to reach for what they have available including opioids x-rays and referrals to specialists Not only are these interventions unhelpful for chronic LBP they are often harmful sometimes deadly and disproportionately affect lower socio-economic status households
A possible solution to this problem exists in a validated app SelfBack that provides tailored self-management plans consisting of advice on physical activity physical exercises and educational content Tailoring of treatment plans to individuals is achieved by using case-based reasoning methodology which is a branch of artificial intelligence
This study will evaluate the feasibility of distributing the SelfBack app to persons experiencing LBP through the Rehabilitation Advice Line a telephone service open Monday to Friday and provides rehabilitation advice and general health information for Albertans of any age
The results of this study will help us understand the barriers and facilitators of distributing and using the app in the general pollution of Alberta This information will be used to apply for funding for a larger study to understand the effectiveness of the app as an intervention for persistent and recurrent LBP
The good news is that treatments for recurrent and persistent LBP are available Many guidelines now recommend education and exercise as the best intervention for chronic LBP Unfortunately education and exercise programs are not publicly funded in Canada-only Canadians with extended health benefits can access these programs
As a result the 50 of Canadians who do not have extended health benefits often seek care for LBP from their publicly funded physicians Physicians in turn have little choice but to reach for what they have available including opioids x-rays and referrals to specialists Not only are these interventions unhelpful for chronic LBP they are often harmful sometimes deadly and disproportionately affect lower socio-economic status households
A possible solution to this problem exists in a validated app SelfBack that provides tailored self-management plans consisting of advice on physical activity physical exercises and educational content Tailoring of treatment plans to individuals is achieved by using case-based reasoning methodology which is a branch of artificial intelligence
This study will evaluate the feasibility of distributing the SelfBack app to persons experiencing LBP through the Rehabilitation Advice Line a telephone service open Monday to Friday and provides rehabilitation advice and general health information for Albertans of any age
The results of this study will help us understand the barriers and facilitators of distributing and using the app in the general pollution of Alberta This information will be used to apply for funding for a larger study to understand the effectiveness of the app as an intervention for persistent and recurrent LBP
Detailed Description:
Purpose
This study will evaluate the feasibility of distributing the SelfBack app through the Rehab Avice Line and the feasibility of patients using the app
Justification
The SelfBack app is a promising decision support system DSS App used globally to support and reinforce desired self-management behavior for LBP Selfbacks program goal is to improve the self-management of nonspecific LBP to reduce pain-related disability Svenden Sandal et al 2020 Using mHealth applications apps has been suggested to be a promising way to increase the effectiveness of self-management interventions Beatty et al 2013 Newman et al 2011
Objectives
Our primary objective is to evaluate the feasibility of distributing and using the SelfBack app A secondary objective is to assess patient outcomes collected by the SelfBack app
Methodology Overview
The Rehabilitation Advice Line will train their employees in the use of the SelfBack and how to distribute this app to patients Rehab Advice Line employees are either licensed physiotherapists or occupational therapists Those patients will be those Albertans who call the Rehab Advice Line and have a complaint of chronic low back pain cLBP Patients who are eligible and consent to participate will be provided with the SelfBack App The SelfBack app then collects patients data and provides patients with personalized advice regarding education and exercise for cLBP De-identified group-level Selfback data will then be downloaded by the investigative team at regular intervals for analysis
Overall timeline and setting
The study will occur between May 2024 to December 2024 8 months
Recruitment and Inclusion Exclusion criteria
Patient Recruitment Rehab Advice Line Employees will identify potential patients through encounters with Albertans who call into the service They will then discuss the study with those patients Interested patients and those meeting the inclusionexclusion criteria will be instructed on how to download the SelfBack app for use on their smartphone They will then be sent an electronic informationconsent form via REDCap by the Rehab Advice Line clinician The phone call will then end following the phone call if the potential participant provides consent the investigative team will be notified via REDCap and will then provide an activation code to the participant to activate the SelfBack app
Patient Inclusion Criteria Patients with persistent andor recurrent LBP Those who benefit most from Selfback are those who have persistent pain when defined as those currently having LBP that has impacted daily activities for 1 month In addition eligible patients will
be Albertan adults over 18 years of age be persons who meet the above definition of LBP but may also include patients with stable radiculopathysciatica have a personal smartphone with internet access have a working e-mail address speak read and write English or have regular access to persons who can assist in this regard
Ineligible patients will
be patients who have complex back pain that requires direct clinical oversight have cognitive impairments or learning disabilities limiting participation have a serious mental illness have non-LBP illnesses or conditions that are contraindicated to participation in SelfBack eg exercise
have a terminal illness have an inability to take part in exercisephysical activity Patient Data
Once the app is activated on the participants smartphone the SelfBack app will ask a series of baseline questions 30 min to establish what educational advice and exercises best suit the participant
The SelfBack app regularly asks questions of the user to determine their ability to participate in exercise and education and evaluate their progress in the program The list of survey questions used by the app was created approved and distributed by Selfback and is attached to this protocol
The SelfBack will collect two categories of data
The first category will be related to patient demographics
The second category is related to patient-related outcome measures a variety of established scales and questionnaires with known psychometric properties These outcome measures are used to assess the participants health status fitness level and psychological health These specific outcomes are asked at baseline 3 and 6 months A list of the patient-reported outcome measures used by SelfBack follows
Roland-Morris Disability Questionnaire RMDQ The RMDQ is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale The RMDQ has been shown to yield reliable measurements which are valid for inferring the level of disability and to be sensitive to change over time for groups of patients with low back pain
The Pain Self-Efficacy Questionnaire PSEQ is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain The PSEQ is a useful tool for assessing an individuals self-efficacy beliefs related to pain management and for identifying individuals who may benefit from interventions to improve their pain management skills and self-efficacy
EuroQol EQ5D The descriptive system comprises five dimensions mobility self-care usual activities paindiscomfort and anxietydepression Each dimension has 5 levels no problems slight problems moderate problems severe problems and extreme problems The patient is asked to indicate hisher health state by ticking the box next to the most appropriate statement in each of the five dimensions This decision results in a 1-digit number that expresses the level selected for that dimension The digits for the five dimensions can be combined into a 5-digit number that describes the patients health state The EQ VAS records the patients self-rated health on a vertical visual analog scale where the endpoints are labeled The best health you can image and The worst health you can image 0-100 The VAS can be used as a quantitative measure of health outcomes that reflects the patients judgment
STarT Back A simple tool to match patients to treatment packages appropriate for them It has been shown to significantly decrease disability from back pain reduce time off work and save money by making better use of health resources This questionnaire helps clinicians identify modifiable risk factors biomedical psychological and social for back pain disability The resulting score can stratify patients into low medium or high-risk categories This tool can also be used to track change over time
Numeric Pain Rating Scale NPRS A 0-10 NPRS 0 no pain and 10 worst pain imaginable will be used to assess LBP intensity The NPRS has excellent test-retest reliability Previous research has found the NPRS to be responsive to change with an MCID of 2 points for patients with acute LBP
Psychosocial Covariate Measures The Fear-Avoidance Beliefs Questionnaire FABQ will be used to measure patients beliefs about how physical activity and work may affect their LBP and perceived risk for re-injury The FABQ work score is a factor in the clinical prediction rule
Clinician - Patient Interaction
Rehab Advice Line staff are also provided with a real-time dashboard where they can receive information about SelfBack users in real-time Specifically the dashboard shows if triggers have occurred that indicates the patient has entered information into the app that requires monitoring or follow-up eg a sudden increase in pain
Analyses
The general procedure for statistical analysis is as follows
Descriptive statistics will be generated which will be cross-tabulated with demographic groups of interest eg gender age community size caregiver status self-identification of disability and ethnic and racial identification
Feasibility will be judged as successful if 50 of the enrolled participants complete the education and exercise program recommended by the app
This study will evaluate the feasibility of distributing the SelfBack app through the Rehab Avice Line and the feasibility of patients using the app
Justification
The SelfBack app is a promising decision support system DSS App used globally to support and reinforce desired self-management behavior for LBP Selfbacks program goal is to improve the self-management of nonspecific LBP to reduce pain-related disability Svenden Sandal et al 2020 Using mHealth applications apps has been suggested to be a promising way to increase the effectiveness of self-management interventions Beatty et al 2013 Newman et al 2011
Objectives
Our primary objective is to evaluate the feasibility of distributing and using the SelfBack app A secondary objective is to assess patient outcomes collected by the SelfBack app
Methodology Overview
The Rehabilitation Advice Line will train their employees in the use of the SelfBack and how to distribute this app to patients Rehab Advice Line employees are either licensed physiotherapists or occupational therapists Those patients will be those Albertans who call the Rehab Advice Line and have a complaint of chronic low back pain cLBP Patients who are eligible and consent to participate will be provided with the SelfBack App The SelfBack app then collects patients data and provides patients with personalized advice regarding education and exercise for cLBP De-identified group-level Selfback data will then be downloaded by the investigative team at regular intervals for analysis
Overall timeline and setting
The study will occur between May 2024 to December 2024 8 months
Recruitment and Inclusion Exclusion criteria
Patient Recruitment Rehab Advice Line Employees will identify potential patients through encounters with Albertans who call into the service They will then discuss the study with those patients Interested patients and those meeting the inclusionexclusion criteria will be instructed on how to download the SelfBack app for use on their smartphone They will then be sent an electronic informationconsent form via REDCap by the Rehab Advice Line clinician The phone call will then end following the phone call if the potential participant provides consent the investigative team will be notified via REDCap and will then provide an activation code to the participant to activate the SelfBack app
Patient Inclusion Criteria Patients with persistent andor recurrent LBP Those who benefit most from Selfback are those who have persistent pain when defined as those currently having LBP that has impacted daily activities for 1 month In addition eligible patients will
be Albertan adults over 18 years of age be persons who meet the above definition of LBP but may also include patients with stable radiculopathysciatica have a personal smartphone with internet access have a working e-mail address speak read and write English or have regular access to persons who can assist in this regard
Ineligible patients will
be patients who have complex back pain that requires direct clinical oversight have cognitive impairments or learning disabilities limiting participation have a serious mental illness have non-LBP illnesses or conditions that are contraindicated to participation in SelfBack eg exercise
have a terminal illness have an inability to take part in exercisephysical activity Patient Data
Once the app is activated on the participants smartphone the SelfBack app will ask a series of baseline questions 30 min to establish what educational advice and exercises best suit the participant
The SelfBack app regularly asks questions of the user to determine their ability to participate in exercise and education and evaluate their progress in the program The list of survey questions used by the app was created approved and distributed by Selfback and is attached to this protocol
The SelfBack will collect two categories of data
The first category will be related to patient demographics
The second category is related to patient-related outcome measures a variety of established scales and questionnaires with known psychometric properties These outcome measures are used to assess the participants health status fitness level and psychological health These specific outcomes are asked at baseline 3 and 6 months A list of the patient-reported outcome measures used by SelfBack follows
Roland-Morris Disability Questionnaire RMDQ The RMDQ is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale The RMDQ has been shown to yield reliable measurements which are valid for inferring the level of disability and to be sensitive to change over time for groups of patients with low back pain
The Pain Self-Efficacy Questionnaire PSEQ is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain The PSEQ is a useful tool for assessing an individuals self-efficacy beliefs related to pain management and for identifying individuals who may benefit from interventions to improve their pain management skills and self-efficacy
EuroQol EQ5D The descriptive system comprises five dimensions mobility self-care usual activities paindiscomfort and anxietydepression Each dimension has 5 levels no problems slight problems moderate problems severe problems and extreme problems The patient is asked to indicate hisher health state by ticking the box next to the most appropriate statement in each of the five dimensions This decision results in a 1-digit number that expresses the level selected for that dimension The digits for the five dimensions can be combined into a 5-digit number that describes the patients health state The EQ VAS records the patients self-rated health on a vertical visual analog scale where the endpoints are labeled The best health you can image and The worst health you can image 0-100 The VAS can be used as a quantitative measure of health outcomes that reflects the patients judgment
STarT Back A simple tool to match patients to treatment packages appropriate for them It has been shown to significantly decrease disability from back pain reduce time off work and save money by making better use of health resources This questionnaire helps clinicians identify modifiable risk factors biomedical psychological and social for back pain disability The resulting score can stratify patients into low medium or high-risk categories This tool can also be used to track change over time
Numeric Pain Rating Scale NPRS A 0-10 NPRS 0 no pain and 10 worst pain imaginable will be used to assess LBP intensity The NPRS has excellent test-retest reliability Previous research has found the NPRS to be responsive to change with an MCID of 2 points for patients with acute LBP
Psychosocial Covariate Measures The Fear-Avoidance Beliefs Questionnaire FABQ will be used to measure patients beliefs about how physical activity and work may affect their LBP and perceived risk for re-injury The FABQ work score is a factor in the clinical prediction rule
Clinician - Patient Interaction
Rehab Advice Line staff are also provided with a real-time dashboard where they can receive information about SelfBack users in real-time Specifically the dashboard shows if triggers have occurred that indicates the patient has entered information into the app that requires monitoring or follow-up eg a sudden increase in pain
Analyses
The general procedure for statistical analysis is as follows
Descriptive statistics will be generated which will be cross-tabulated with demographic groups of interest eg gender age community size caregiver status self-identification of disability and ethnic and racial identification
Feasibility will be judged as successful if 50 of the enrolled participants complete the education and exercise program recommended by the app
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None