ADHERE Trial: Strategies to Improve Mobile App Adherence

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое App notifications
  Participants will receive the standard app notifications .

Первичные конечные точки

• Number of sessions completed [Срок оценки: Week 8 post-randomisation]

Вторичные конечные точки (4)

• Adherence rate (completer vs. non-completer) [Срок оценки: Week 8 post-randomisation]
• Missing follow-up rate [Срок оценки: Week 8 post-randomisation]
• Withdrawal rate [Срок оценки: Week 8 post-randomisation]
• Cost-effectiveness [Срок оценки: Week 8 post-randomisation]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Neuroscience Research Australia — Sydney

Идентификаторы

NCT: NCT07205991 · iRECS4383 - SWAT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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