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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App-based self-management tool plus usual care | Experimental | App-based self-management tool consisting of pain education and clinical hypnosis delivered after usual care. |
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| Patient information digital fact-sheet plus usual care | Experimental | The intervention consists of a fact-sheet delivered after usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App-based self-management tool plus usual care | Behavioral | The app-based self-management tool will be delivered after patients receive usual care from their general practitioners. The 8-week mobile app intervention will involve daily sessions on pain education and clinical hypnosis for back pain management (5 minutes, 15 minutes of listening to hypnotherapy audio and engaging in physical/social activities for 5 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Individuals meeting the preliminary eligibility criteria | 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). | From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week. |
| General practitioners who agreed to prescribe a digital intervention | Proportion of general practitioners who agreed to prescribe a digital intervention as part of the study compared to all eligible individuals (data from BetterConsult). | From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week. |
| Individuals who recieved participant information form compared to those that met the preliminary eligibility criteria | 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). | From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week. |
| Individuals who completed the full eligibility criteria compared to those who shared their details | 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). | From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James H McAuley, PhD | Neuroscience Research Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuroscience Research Australia | Randwick | New South Wales | 2031 | Australia |
De-identified individual participant data will be made to interested researchers only upon reasonable request and once the proposed research project has received separate ethics approval from a Human Research Ethics Committee.
Request to the data custodian, the Principal Investigator (j.mcauley@neura.edu.au).
Data will be made available after the publication of study reports. There is no end date for the availability of study data.
Protocol and ethics must be provided.
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| Patient information digital fact-sheet plus usual care | Behavioral | The face-sheet will be delivered after patients receive usual care from their general practitioners.This digital intervention will contain educational material for chronic back pain that includes details about diagnosis, prognosis and treatment options. |
|
| Number of individuals who provided consent to participate | Number of individuals who provided consent to participate in the feasibility study (collected by the research group via REDCap). | 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 MBS and PBS data. | 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). | 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 baseline questionnaires | 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). | From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week. |
| Recruitment rate per day, week or month. | Number of individuals randomised in a given day, week or month (collected by the research group via REDCap) | From the recruitment start date until the randomisation of 60 participants or 1 year, whichever came first, assessed every week. |
| The Acceptability of Intervention Measure | 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. | Baseline and 8 week follow-up |
| The Appropriateness of Intervention Measure | 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. | Baseline and 8 week follow-up |
| Completion rate of questionnaires | 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. | Baseline and 8 week follow-up |
| Adherence to the digital intervention | The proportion of individuals who adhered to the digital intervention (i.e., the proportion of participants who completed each session (data from Mindset Health). | Throughout the intervention to the 8 week follow-up |
| Mobile App Rating Satisfaction Sub-Scale | 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). | 8 week follow-up |
| Participants experience through semi-structured interview | Qualitative study on participants experience in the feasibility study (with at least 6 participants). | 8 week follow-up |
| Adverse events | Assessed by self-reported information | 8 week follow-up |
| Participants experience with the intervention | 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? | 8-week follow-up |
| D013568 |
| Pathological Conditions, Signs and Symptoms |