Menu
Recruiting NCT07205991

ADHERE Trial: Strategies to Improve Mobile App Adherence

No phase Interventional Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Phone calls, Text messages, App notifications.
Who it may be relevant to
Registry conditions: Low Back Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral Phone calls
    Participants will receive standard app notifications and be contacted for adherence via two phone calls, a week apart, if they fail to engage with the intervention for more than three consecutive days. The purpose of these calls will be to assess whether participants are experiencing any difficulties using the app or completing the sessions.
  • Behavioral Text messages
    Participants will receive the standard app notifications and receive a maximum of 2 text messages (SMS) a week apart, if they fail to engage with the intervention for more than three consecutive days.
  • Behavioral App notifications
    Participants will receive the standard app notifications .

Primary outcome measures

  • Number of sessions completed [Time frame: Week 8 post-randomisation]
Secondary outcome measures (4)
  • Adherence rate (completer vs. non-completer) [Time frame: Week 8 post-randomisation]
  • Missing follow-up rate [Time frame: Week 8 post-randomisation]
  • Withdrawal rate [Time frame: Week 8 post-randomisation]
  • Cost-effectiveness [Time frame: Week 8 post-randomisation]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Neuroscience Research Australia — Sydney

Identifiers

NCT: NCT07205991 · iRECS4383 - SWAT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗