ADHERE Trial: Strategies to Improve Mobile App Adherence
ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeuroscience Research Australia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Phone calls
BehavioralParticipants 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.
Text messages
BehavioralParticipants 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.
App notifications
BehavioralParticipants will receive the standard app notifications .
Treatment groups
258 Participants
are divided into 3 treatment groupsGroup A: App notificationsActive comparator 1 intervention
Group B: Phone callsExperimental treatment 1 intervention
Group C: Text messagesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of sessions completed
Mean difference of the number of sessions completed over 8 weeks between groups.
Time frame
Week 8 post-randomisationSecondary outcomes
1
Adherence rate (completer vs. non-completer)
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.
Time frame
Week 8 post-randomisation2
Missing follow-up rate
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.
Time frame
Week 8 post-randomisation3
Withdrawal rate
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.
Time frame
Week 8 post-randomisation4
Cost-effectiveness
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.
Time frame
Week 8 post-randomisationSponsors and contacts
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Source ClinicalTrials.gov