None listed
Conditions
Brief summary
Our project aims to evaluate the feasibility of a digital self-management App, StudyU, for testing the individual effectiveness of different non-drug treatments in reducing the pain disability associated with chronic non-cancer pain, including but not limited to, pain persisting after Road Traffic Crashes. StudyU is a new, free, mobile phone App, which allows patients to rigorously compare different interventions using gold-standard Single Case Experimental Designs (SCEDs) (personalised single patient behavioural experiments). SCEDs provide a very high level of evidence to evaluate treatment effectiveness in individual patients, empowering them to adopt treatments that help their pain, and discontinue ineffective treatments (even if these are generally recommended). The StudyU App sends patients daily reminders to record pain levels, functional impact and any additional pain medication use. After each trial, it visually displays results (eg pain ratings) for patients. Additionally, sophisticated statistical analyses compare baseline and treatment conditions so doctors can discuss treatment effectiveness with their patient. Testing the effectiveness of different self-management treatment options, such as lifestyle/behavioural interventions, empowers patients to self-manage persistent pain, in partnership with their treating practitioner.
Interventions
A list of potential interventions, all available locally at no or low cost to the participant, includes:
• Walking program set up during visit to physiotherapist or exercise physiologist (on Chronic Disease Management Plan)
• Healthy Ageing Group Exercise
• Online CBT eg MindSpot
• Meditation – eg smiling mind app
• Pain neuroscience education eg Curable app
• Gym program
• Yoga program
• Pilates
• Aquarobics
• Hydrotherapy classes
• Tai chi.
This is delivered for 6 weeks at a frequency chosen b
A list of potential interventions, all available locally at no or low cost to the participant, includes: • Walking program set up during visit to physiotherapist or exercise physiologist (on Chronic Disease Management Plan) • Healthy Ageing Group Exercise • Online CBT eg MindSpot • Meditation – eg smiling mind app • Pain neuroscience education eg Curable app • Gym program • Yoga program • Pilates • Aquarobics • Hydrotherapy classes • Tai chi. This is delivered for 6 weeks at a frequency chosen by the patient. Participants may choose up to 2 interventions each to be undertaken over a 10 week period. StudyU (app.studyu.health) is an innovative online self-management treatment platform—it allows patients to rigorously compare different pain management interventions using gold-standard N-of-1 trials (personalised single patient behavioural experiments), empowering them to adopt interventions that help their pain most. The StudyU mobile App will support patients to assess the effect of the nonpharmacological pain self-management intervention. The exact intervention components, design features and timeframes for interventions and washout periods will be decided through each patient’s design consultation with the study team. If a patient selects an intervention e.g. a 6 week exercise program to trial using a Single Case Experimental Design (SCED) design, then a 2 week A – 6 week B – 2 week A design would be used. - interventions will be delivered by health professionals or trained instructors - the mode of delivery can be face-to-face, group, individual, or online, depending on patient preference - most programs eg the gym program, involves weekly 1 h classes for 6 consecutive weeks - the actual intervention will be selected by the patient and their GP in a consultation - participants can undertake only one intervention at any one time, but may test another intervention after finishing their trial if they wish - strategies used to assess or monitor adherence include participant self report daily. - internal app analytics will monitor fidelity to the intervention.
Sponsors
The University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) >18 years, 2) currently experiencing clinically significant subacute or persistent pain most days per week (average pain severity in last week of at least 3-4/10), 3) on stable dose/s of regular pain medication (including medicinal cannabis) for >/= 4 weeks prior, or not currently taking pain medication, 4) no recent changes (in last 4 weeks) in any usual pain treatment program.
Exclusion criteria
1) Cancer pain 2) acute mental health disorder or suicidal, 3) unable to use digital health apps due to impairments in cognition, vision or dexterity 4) non-English speaking, 5) no access to smartphone or Internet, 6) injection of long-acting pain medication within last 4 weeks 7) surgery planned within next 3 months.
Outcome results
None listed