[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608779":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":35,"interventions":53,"overallOfficials":26,"centralContacts":64,"locations":74,"responsibleParty":90,"collaborators":26,"id":94,"slug":26,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":26,"enrollmentInfo":103,"targetDuration":26,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Neuroscience Research Australia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Number of sessions completed","Mean difference of the number of sessions completed over 8 weeks between groups.","Week 8 post-randomisation",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"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.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"RANDOMIZED","PARALLEL","The study will randomly allocate participants from the intervention group of the NOTUS Trial into one of three parallel arms in a 1:1:1 ratio.","TREATMENT",{"masking":33,"maskingDescription":34,"whoMasked":26},"NONE","General practitioners and statisticians will be blind to group allocation. Blinding will be maintained for the entire duration of the trial until all data have been collected, and data analysis and interpretation have been completed. The personnel involved in the daily operations of the trial (e.g., research assistants and investigators who will provide possible technical support to participants and trial managers) will be unblinded to group allocation and will not be involved in the analyses.",[36,42,48],{"label":37,"type":38,"description":39,"interventionNames":40},"App notifications","ACTIVE_COMPARATOR","Participants will receive the standard app notifications. Reminders are automatically sent at 8pm each day. A user can change the time of their reminder or turn off reminders in the app. The purpose of the app notifications is to increase motivation to complete the app sessions. An example app notification is: Your path to pain management is just a session away. Have you listened today?",[41],"Behavioral: App notifications",{"label":43,"type":44,"description":45,"interventionNames":46},"Phone calls","EXPERIMENTAL","Participants will receive standard app notifications, and if they do not engage with the intervention for more than three consecutive days , they will be contacted for adherence with up to two phone calls or voice messages, one week apart. The purpose of these calls will be to increase motivation and assess whether participants are experiencing any difficulties using the app or completing the sessions. We expect the calls to last no longer than five minutes. The phone call will include the following communication: Hi \\[Name\\], it's \\[Researcher\\] from Neuroscience Research Australia calling about the NOTUS back pain trial. I saw that you've done a few sessions on the NOTUS app - great job! We haven't seen you in the Relio app lately, so I wanted to check in and see if everything is working okay or if you need any help with anything. We look forward to seeing you back on the app as you continue retraining your pain system.",[47],"Behavioral: Phone calls",{"label":49,"type":44,"description":50,"interventionNames":51},"Text messages","Participants will receive the standard app notifications, and if they do not engage with the intervention for more than three consecutive days , they will be contacted for adherence with up to two SMS reminders, one week apart. The purpose of these SMS will be to increase motivation and assess whether participants are experiencing any difficulties using the app or completing the sessions. The text messages will include the following: Hey \\[Name\\], this is \\[Researcher\\] from Neuroscience Research Australia. I saw that you've done a few sessions on the NOTUS app - great job! We haven't seen you in the Relio app lately, so I wanted to check in and see if everything is working okay or if you need any help with anything. We look forward to seeing you back on the app as you continue retraining your pain system.",[52],"Behavioral: Text messages",[54,58,61],{"type":55,"name":43,"description":56,"armGroupLabels":57,"otherNames":26},"BEHAVIORAL","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.",[43],{"type":55,"name":49,"description":59,"armGroupLabels":60,"otherNames":26},"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.",[49],{"type":55,"name":37,"description":62,"armGroupLabels":63,"otherNames":26},"Participants will receive the standard app notifications .",[37],[65,70],{"name":66,"role":67,"phone":68,"phoneExt":26,"email":69},"James H McAuley, PhD","CONTACT","+61293991266","j.mcauley@neura.edu.au",{"name":71,"role":67,"phone":72,"phoneExt":26,"email":73},"Rodrigo RN Rizzo, PhD","(02) 9399 1000","r.rizzo@neura.edu.au",[75],{"facility":5,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"RECRUITING","Sydney","New South Wales","2031","Australia","AU",{"type":83,"coordinates":84},"Point",[85,86],151.20732,-33.86785,{"lat":86,"lon":85},[89],{"name":66,"role":67,"phone":68,"phoneExt":26,"email":69},{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","James McAuley","Principal Investigator","100608779",false,"NCT07205991","ADHERE Trial: Strategies to Improve Mobile App Adherence","Assisting Digital HEalth REtention (ADHERE Trial): Protocol for a Study Within a Trial (SWAT)","ADHERE","Inclusion Criteria:\n\n* Experiencing non-specific chronic low back pain (LBP), defined as pain between the 12th rib and the buttock crease.\n* LBP with or without leg pain (in case of leg pain, LBP is worse than leg pain).\n* Currently consulting with a general practitioner for their non-specific chronic LBP across Australia.\n* Mean pain intensity score on the Numeric Rating Scale ≥ 3\u002F10 in the past week.\n* A score of at least moderate on question 8 of the physical functioning component of the SF-36 questionnaire.\n* Access to a mobile device with minimal requirements to download the study app (300MB).\n* An internet connection to access the mobile app functionalities.\n* Able to understand English via reading and audio materials.\n* Randomised to experimental group at NOTUS Trial.\n\nExclusion Criteria:\n\n* Known or suspected specific spinal (e.g., radiculopathy, fracture) or specific non-spinal non- (e.g., tumour, infection) pathology.\n* Less than six months post-spinal surgery.\n* Scheduled for major surgery during the program or the follow-up period.\n* Known or suspected serious psychiatric condition not being treated by a health professional that would impact adherence to the trial activities.\n* Known or suspected sight or hearing problems that would limit access to the intervention components (reading and listening using headphones).","ALL","18 Years",{"count":104,"type":105},258,"ESTIMATED","INTERVENTIONAL",[108],"NA","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:\n\nDo phone calls or text messages increase adherence compared to app notifications in patients receiving a digital health intervention for chronic back pain?\n\nParticipants will:\n\nA) 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.",[111],"Low Back Pain",[113,114,115,116,117],"Back Pain","Digital Health","Hypnosis","Pain Education","Chronic Pain","2026-01-12",{"date":120,"type":121},"2026-01-14","ACTUAL",{"date":123,"type":121},"2025-10-30",{"date":125,"type":105},"2028-05-26",{"name":5,"class":6},1]