NOTUS Feasibility Trial: Enhancing Chronic Back Pain Management With Mobile App-based Pain Education and Clinical Hypnosis in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Individuals meeting the preliminary eligibility criteria
研究概览
简要总结
This feasibility study will investigate the feasibility of screening, recruiting, and delivering a mobile app intervention that involves pain education and clinical hypnosis to people seeking treatments for chronic low back pain (chronic LBP) in general practices in Australia.
This study aims to assess the recruitment strategy, the willingness of participants to be included in the proposed treatments, whether the intervention can be delivered as intended within the health care system and clinical setting, the adherence of participants to the proposed treatment, response rates to questionnaires, loss to the short-term follow-up, and the appropriateness and acceptability of the interventions. This feasibility study will inform possible modifications in the recruitment and treatments for the main clinical trial.
A total of 60 participants will be randomised into two treatment groups.
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
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 chronic LBP, defined as pain in the area between the 12th rib and buttock crease accompanied or not by leg pain for a minimum duration of 12 weeks.
- •LBP with or without leg pain (in case of leg pain, LBP is worse than leg pain).
- •Currently attending general practice across Australia.
- •Mean pain intensity score on the NRS ≥ 3/10 in the past week.
- •A score of at least moderate on question 8 of the physical functioning component of the SF36 questionnaire.
- •Access to a mobile device with minimal requirements to download the study app (300MB).
- •Internet connection to access the mobile app functionalities.
- •Able to understand English via reading and audio materials.
- •Individuals who reported interest in participating in a clinical trial involving digital interventions after consultation with their general practitioners.
- •Individuals whose general practitioners permitted them to receive information about the trial after the general practice consultation.
排除标准
- •Known or suspected back-specific (e.g., radiculopathy, fracture) or non-back-specific (e.g., tumour, infection) serious spinal 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 the 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
Individuals meeting the preliminary eligibility criteria
时间窗: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Proportion of individuals meeting the preliminary eligibility criteria in the pre-consultation tool BetterConsult and who agreed to receive a digital intervention as part of the study, compared to all eligible individuals reporting back pain as the primary health issue in the BetterConsult tool (data from BetterConsult).
General practitioners who agreed to prescribe a digital intervention
时间窗: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Proportion of general practitioners who agreed to prescribe a digital intervention as part of the study compared to all eligible individuals (data from BetterConsult).
Individuals who recieved participant information form compared to those that met the preliminary eligibility criteria
时间窗: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Proportion of individuals who received the Participant Information Form and shared their name, phone number, and email to be contacted by the research group (data from the research group) compared to those who met the preliminary eligibility criteria and whose general practitioners agreed to prescribe a digital intervention as part of the trial (data from BetterConsult).
Individuals who completed the full eligibility criteria compared to those who shared their details
时间窗: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Proportion of individuals who completed the full eligibility criteria for the study compared to those who shared their details after receiving the Participant Consent Form (data from the research group).
Number of individuals who provided consent to participate
时间窗: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Number of individuals who provided consent to participate in the feasibility study (collected by the research group via REDCap).
Number of individuals who provided consent for the research group to collect MBS and PBS data.
时间窗: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Number of individuals who provided consent for the research group to collect Medicare Benefits Scheme and Pharmaceutical Benefits Scheme data (collected by the research group via REDCap).
Proportion of individuals who completed the baseline questionnaires
时间窗: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Proportion of individuals who completed the socio-demographic baseline questions compared to all individuals who consented to participate in the feasibility study (data from the research group).
Recruitment rate per day, week or month.
时间窗: From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week.
Number of individuals randomised in a given day, week or month (collected by the research group via REDCap)
The Acceptability of Intervention Measure
时间窗: Baseline and 8 week follow-up
The Acceptability of Intervention Measure (AIM) questionnaire ranges from 1 to 5; completely disagree, disagree, neither agree nor disagree, agree, completely agree. Higher scores indicate greater acceptability.
The Appropriateness of Intervention Measure
时间窗: Baseline and 8 week follow-up
The Appropriateness of Intervention Measure (AIM) questionnaire ranges from 1 to 5; completely disagree, disagree, neither agree nor disagree, agree, completely agree. Higher score indicates a higher level of appropriateness.
Completion rate of questionnaires
时间窗: Baseline and 8 week follow-up
The completion rate of questionnaires at baseline and the eight-week follow-up include: 0 to 10 numeric rating scale average pain and worst pain intensity, 0 to 24 Ronald Morris Disability Questionnaire and DASS-21 (depression, anxiety and stress sub-scales), higher scores indicate worse outcomes. Acceptability of Intervention Measure and Intervention Appropriateness Measure (1 to 5, higher scores indicate better outcomes) The completion rate of questionnaires at the 8-week follow-up include: -5 to 5 Global Perceived Effect Scale, 0 to 1 EuroQol 5 dimensions questionnaire, 0 to 12 Short-Form Pain Self-Efficacy Questionnaire, 0 to 100 Credibility/Expectancy Questionnaire (expectancy sub-scale) and 1 to 5 Mobile App Rating Satisfaction Sub-Scale, higher scores indicate better outcomes. 0 to 28 Short-Form Pain Catastrophising Scale, 9 to 45 Back Beliefs Questionnaire, 11 to 44 Short-Form Tampa Scale for Kinesiophobia, higher scores indicate worse outcomes.
Adherence to the digital intervention
时间窗: Throughout the intervention to the 8 week follow-up
The proportion of individuals who adhered to the digital intervention (i.e., the proportion of participants who completed each session (data from Mindset Health).
Mobile App Rating Satisfaction Sub-Scale
时间窗: 8 week follow-up
We will assess satisfaction sub-scale using two questions from the Mobile App Rating Scale. Each item ranges from 1 to 5 (higher score indicates a greater level of satisfaction).
Participants experience through semi-structured interview
时间窗: 8 week follow-up
Qualitative study on participants experience in the feasibility study (with at least 6 participants).
Adverse events
时间窗: 8 week follow-up
Assessed by self-reported information
Participants experience with the intervention
时间窗: 8-week follow-up
This study will qualitatively investigate the participants experience with three open-ended questions. These questions include: 1. What have you learned or experienced that has been the most helpful to you? 2. How do you see yourself applying the intervention to your daily life in the long term? 3. What else could we do to help you incorporate the intervention into your daily life?
次要结局
未报告次要终点
研究者
James McAuley
Principal Investigator
Neuroscience Research Australia