ADHERE Trial: Strategies to Improve Mobile App Adherence

Assisting Digital HEalth REtention (ADHERE Trial): Protocol for a Study Within a Trial (SWAT)

This study aims to evaluate the effectiveness of two communication interventions, compared to standard app notifications, in increasing adherence to a mobile health app among individuals with chronic low back pain. The main question it aims to answer is:

Do phone calls or text messages increase adherence compared to app notifications in patients receiving a digital health intervention for chronic back pain?

Participants will:

A) Receive pain education and clinical hypnosis via a mobile app for managing chronic LBP; B) Will be contacted up to twice via phone call or text message, or they will only receive standard notifications from the app.

Inclusion Criteria:

• Experiencing non-specific chronic low back pain (LBP), defined as pain between the 12th rib and the buttock crease.
• LBP with or without leg pain (in case of leg pain, LBP is worse than leg pain).
• Currently consulting with a general practitioner for their non-specific chronic LBP across Australia.
• Mean pain intensity score on the Numeric Rating Scale ≥ 3/10 in the past week.
• A score of at least moderate on question 8 of the physical functioning component of the SF-36 questionnaire.
• Access to a mobile device with minimal requirements to download the study app (300MB).
• An internet connection to access the mobile app functionalities.
• Able to understand English via reading and audio materials.
• Randomised to experimental group at NOTUS Trial.

Exclusion Criteria:

• Known or suspected specific spinal (e.g., radiculopathy, fracture) or specific non-spinal non- (e.g., tumour, infection) pathology.
• Less than six months post-spinal surgery.
• Scheduled for major surgery during the program or the follow-up period.
• Known or suspected serious psychiatric condition not being treated by a health professional that would impact adherence to the trial activities.
• Known or suspected sight or hearing problems that would limit access to the intervention components (reading and listening using headphones).