Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06347991 |
Other study ID # |
Pro00140155 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2024 |
Est. completion date |
December 31, 2025 |
Study information
Verified date |
April 2024 |
Source |
University of Alberta |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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. Selfback's 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 participant's 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 participant's 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 (e.g., 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.