Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347991
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-03-17
Brief Title:
Alberta Chiropractic SelfBack Study
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Alberta Chiropractic 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 CBR methodology which is a branch of artificial intelligence
This study will evaluate the feasibility of distributing the SelfBack app to persons experiencing LBP through their chiropractors
The results of this study will help us understand the barriers and facilitators of distributing and using the app through Alberta Chiropractors 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 CBR methodology which is a branch of artificial intelligence
This study will evaluate the feasibility of distributing the SelfBack app to persons experiencing LBP through their chiropractors
The results of this study will help us understand the barriers and facilitators of distributing and using the app through Alberta Chiropractors 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 members of the Chiropractic Association of Alberta 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 behaviour for LBP Selfbacks program goal is to improve the self-management of nonspecific low back pain LBP to reduce pain-related disability Using applications apps has been suggested to be a promising way to increase the effectiveness of self-management interventions
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 Chiropractic Association of Alberta CAA will recruit members who are interested in being enrolled in the study Those who meet the eligibility criteria and provide consent will then be trained in the SelfBack app and then respond to a baseline survey to determine their current attitudes and beliefs regarding using the SelfBack app Trained and enrolled chiropractors will then identify chronic LBP patients in their own practice to receive the SelfBack App Patients who are eligible and consent to participate will be provided with the SelfBack App The SelfBack app then collects patient data and provides patients with personalized advice regarding education and exercise for chronic LBP De-identified group-level Selfback data will then be downloaded by the investigative team at regular intervals for analysis Finally chiropractors will provided with a follow-up survey to evaluate their attitudes and beliefs following their involvement in the trial
Overall timeline and setting
The study will occur between May 2024 and December 2024 8 months
Patient Data
Once patients provide consent to the Investigative Team they will be sent instructions on how to download and use the SelfBack app Once installed 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
Clinician - Patient Interaction
Chiropractors are not excluded from seeing their patients while patients are using the SelfBack app Clinical encounters may occur for heart concerns that are unrelated to the study or require in-person evaluation to determine and evaluate their ability to continue in the study
Clinicians are also provided with a real-time dashboard through Selfback where they can receive information about SelfBack users in real-time Specifically the dashboard shows if triggers have occurred which indicates the patient has entered information into the app which requires monitoring or follow-up
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 members of the Chiropractic Association of Alberta 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 behaviour for LBP Selfbacks program goal is to improve the self-management of nonspecific low back pain LBP to reduce pain-related disability Using applications apps has been suggested to be a promising way to increase the effectiveness of self-management interventions
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 Chiropractic Association of Alberta CAA will recruit members who are interested in being enrolled in the study Those who meet the eligibility criteria and provide consent will then be trained in the SelfBack app and then respond to a baseline survey to determine their current attitudes and beliefs regarding using the SelfBack app Trained and enrolled chiropractors will then identify chronic LBP patients in their own practice to receive the SelfBack App Patients who are eligible and consent to participate will be provided with the SelfBack App The SelfBack app then collects patient data and provides patients with personalized advice regarding education and exercise for chronic LBP De-identified group-level Selfback data will then be downloaded by the investigative team at regular intervals for analysis Finally chiropractors will provided with a follow-up survey to evaluate their attitudes and beliefs following their involvement in the trial
Overall timeline and setting
The study will occur between May 2024 and December 2024 8 months
Patient Data
Once patients provide consent to the Investigative Team they will be sent instructions on how to download and use the SelfBack app Once installed 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
Clinician - Patient Interaction
Chiropractors are not excluded from seeing their patients while patients are using the SelfBack app Clinical encounters may occur for heart concerns that are unrelated to the study or require in-person evaluation to determine and evaluate their ability to continue in the study
Clinicians are also provided with a real-time dashboard through Selfback where they can receive information about SelfBack users in real-time Specifically the dashboard shows if triggers have occurred which indicates the patient has entered information into the app which requires monitoring or follow-up
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