Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07205991

Assisting Digital Health Retention (ADHERE Trial): Study Within a Trial to Improve Mobile App Adherence for Chronic Low Back Pain

Led by Neuroscience Research Australia · Updated on 2026-01-14

258

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate whether phone calls or text messages improve adherence to a mobile health app compared to standard app notifications among adults living with chronic low back pain. The study focuses on individuals experiencing non-specific chronic low back pain who are currently consulting a general practitioner and have a minimum pain intensity score. It seeks to answer if these communication methods increase engagement with digital pain management interventions. Participants will receive pain education and clinical hypnosis through a mobile app designed for chronic low back pain management. They will be randomly assigned to one of three groups: one receiving only standard daily app notifications, another receiving notifications plus up to two phone calls if they miss app sessions for more than three days, and the last receiving notifications plus up to two text messages under the same conditions. The phone calls and texts are spaced one week apart and aim to motivate participants and check for difficulties using the app. Throughout the 8-week study period, researchers will monitor the number of app sessions completed, adherence rates, withdrawal rates, and missing follow-up rates. Participants' progress will be tracked through app usage data and communication records. The study also assesses cost-effectiveness and safety by monitoring participant engagement and any issues reported during calls or messages. The total participation duration aligns with the 8 weeks following randomization.

CONDITIONS

Brief Title

ADHERE Trial: Strategies to Improve Mobile App Adherence

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Experiencing non-specific chronic low back pain between the 12th rib and buttock crease
  • Low back pain with or without leg pain, but back pain is worse than leg pain if leg pain is present
  • Currently consulting with a general practitioner for non-specific chronic low back pain in Australia
  • Mean pain intensity score of 3 or higher on the Numeric Rating Scale in the past week
  • At least moderate score on question 8 of the physical functioning section of the SF-36 questionnaire
  • Access to a mobile device that can download the study app (requires about 300MB)
  • Internet connection to use the mobile app features
  • Able to understand English through reading and listening
  • Randomized to an experimental group in the NOTUS Trial
Not Eligible

You will not qualify if you...

  • Known or suspected specific spinal problems such as radiculopathy or fracture
  • Known or suspected non-spinal conditions like tumor or infection causing back pain
  • Less than six months since spinal surgery
  • Scheduled for major surgery during the study or follow-up period
  • Untreated serious psychiatric condition that might affect study participation
  • Known or suspected sight or hearing problems limiting ability to use reading or audio parts of the app (e.g., need for headphones)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 8 weeks

Participants use a mobile app for managing chronic low back pain. They receive daily app notifications as reminders to complete sessions. Depending on their group, participants may also receive up to two phone calls or two text messages to encourage adherence if they do not engage with the app for more than three consecutive days.

Daily app notifications with up to 2 phone calls or text messages spaced one week apart if needed

Trial Site Locations

Total: 1 location

1

Neuroscience Research Australia

Sydney, New South Wales, Australia, 2031

Actively Recruiting

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Research Team

J

James H McAuley, PhD

R

Rodrigo RN Rizzo, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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