ADHERE Trial: Strategies to Improve Mobile App Adherence

Not Applicable

Not yet recruiting

• Conditions: Low Back Pain

• Registration Number: NCT07205991
• Lead Sponsor: Neuroscience Research Australia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-23
• Study First Submitted: 2025-09-25
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2027-05-26
• Study Completion: 2028-05-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 258

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of sessions completed	Week 8 post-randomisation	Mean difference of the number of sessions completed over 8 weeks between groups.

Secondary Outcome Measures

Name	Time	Method
Adherence rate (completer vs. non-completer)	Week 8 post-randomisation	Participants will be classified as "completers" if they have attended at least 24 sessions (new or repeated) during the 8-week treatment period of the host trial. This threshold represents an average of three clinical sessions per week over 8 weeks.
Missing follow-up rate	Week 8 post-randomisation	Participants will be classified as "follow-up completer" when they completed all primary, secondary and intermediate measures or as "follow-up missing" when they did not complete all primary, secondary and intermediate measures at the 8-week follow-up.
Withdrawal rate	Week 8 post-randomisation	Participants will be classified as "withdrawal" if they formally withdrew consent, or as "non-withdrawal" if they remained enrolled in the trial at the 8-week follow-up.
Cost-effectiveness	Week 8 post-randomisation	The mean difference in costs and adherence between groups will be used to calculate the incremental cost-effectiveness ratio (ICER), representing the average additional cost (expressed in Australian dollars - AUD) required to achieve one additional completed session. This outcome reflects the economic efficiency of each engagement strategy (SMS or phone call) compared to others.

Trial Locations

Locations (1)

Neuroscience Research Australia; 🇦🇺 Sydney, New South Wales, Australia