Assisting Digital HEalth REtention (ADHERE Trial): Protocol for a Study Within a Trial (SWAT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 258
- 试验地点
- 2
- 主要终点
- Number of sessions completed
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Number of sessions completed
时间窗: Week 8 post-randomisation
Mean difference of the number of sessions completed over 8 weeks between groups.
次要结局
- Adherence rate (completer vs. non-completer)(Week 8 post-randomisation)
- Missing follow-up rate(Week 8 post-randomisation)
- Withdrawal rate(Week 8 post-randomisation)
- Cost-effectiveness(Week 8 post-randomisation)
- Adherence rate (completer vs. non-completer)(Week 8 post-randomisation)
- Missing follow-up rate(Week 8 post-randomisation)
- Withdrawal rate(Week 8 post-randomisation)
- Cost-effectiveness(Week 8 post-randomisation)
研究者
James McAuley
Principal Investigator
Neuroscience Research Australia