None listed
Conditions
Brief summary
Rurality and remoteness are associated with increased risk of diabetes-related foot ulcerations (sores) and lower limb amputation because people who live in rural areas are more likely to have diabetes and have reduced access to traditional preventative services. This study aims to assess the feasibility of using a short, face to face podiatrist-led intervention to support the adoption and utilisation of a smart-insole in a rural population. Ten people with diabetes-related nerve damage in the feet and two podiatrists will be recruited. An experienced health-coach will provide face to face training to the enrolled podiatrists in how to use health coaching strategies to support participants in using the SurroSense Rx smart-insole insole, which monitors foot pressure and weight bearing activity. Participants will wear the smart-insole in their shoes for four weeks, responding to alerts delivered via the associated smart-watch.
Interventions
Podiatrist Intervention: i. Short face-to-face lecture and demonstration training session (90 - 120 minutes) conducted for two podiatrists in using a health coaching approach to issue the SurroSense Rx smart-insole. Session will be held in an outpatient clinic. Health coaching training will be provided by an experienced health coach with > 5 years of experience using the technique. Health coaching utilises a range of techniques to assess a person’s readiness to change, assist them to identify health care goals and the specific steps and actions that support achievement of these goals. Techniques may include teach-back, goal-setting techniques such as Specific, Measurable, Achievable, Relevant and Time-related (S.M.A.R.T) goals, motivational interviewing and patient education. ii. 30 - 45 minute face to face demonstration session for podiatrists in how to use the SurroSense Rx smart-insole. Training will be provided in an outpatient clinic to a group of 2 podiatrists by a study researcher who is a registered podiatrist and has prior training in the use of the insole. The researcher will use SurroSense Rx insole information provided by Orpyx Medical Technologies to support podiatrist training in usage of the device. iii. Feedback face to face session will be provided to podiatrists individually in their own practice setting. Feedback regarding their clients' summary baseline data from Nottingham Assessment of Functional Footcare questionnaire and Patient Interpretation of Neuropathy questionnaire will be provided to the device-issuing podiatrist. Participant enrolment: i. At enrolment, participants will be provided with information about the study and will be asked to provide written consent to participate in the study. At enrolment participants will undergo a neurovascular foot examination conducted by a registered podiatrist to confirm eligibility. At enrolment participants will be asked to complete three questionnaires; Unified Theory of Acceptance and Use of Technology questionnaire, Nottingham Assessment of Functional Footcare questionnaire and Patient Interpretation of Neuropathy questionnaire. Participant Intervention: Podiatrist-led, standardised face-to-face, one-on-one health coaching clinical consultation during the issuing of a SurroSense Rx smart insole from Orpyx Medical Technologies Inc (Canada) to support foot health self-monitoring and utilisation of SurroSense Rx smart-insole. The SurroSense Rx smart insole is a shoe insert that is a foot ulcer prevention system. The device uses sensors to monitor the amount of pressure applied on the plantar aspect of the foot throughout the day. When pressure areas are high, an alert is transmitted wirelessly to the person’s smartwatch. This information can be used by the wearer to modify their behaviour and off-load pressure, avoiding injury. Participants will be asked to wear the insole for every step they take and whenever they are placing their feet on the ground - no set wear time per day. Participants will be shown how to use the SurroSense Rx insole by the issuing podiatrist. ii. Brief podiatry follow-up intervention via telephone, email or face to face with participants two weeks into the trial. Duration of follow-up consultation is determined by participant need. iii. Participant adoption and usage of the Surrosense Rx smart insole over a four-week period.
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion criteria for podiatrists i. Registered podiatrist working in Shepparton Victoria. ii. Clinically treats people with diabetes-related peripheral neuropathy without active foot ulcerations. Inclusion criteria for participants i. Age > 18 years. ii. Type 1 or Type 2 Diabetes. iii. Peripheral neuropathy as determined by 10g monofilament and 128Hz graduated tuning fork tests and pinprick discrimination. iv. Absolute Toe Pressure > 60mmHg. v. Willing to wear lace-up footwear compatible with SurroSense Rx smart insole. vi. Able to attend appointments in the regional centre of Shepparton, Victoria.
Exclusion criteria
Exclusion criteria for podiatrists i. Unwilling to commit the time required to be trained in the health coaching technique to be used in this study. ii. Unwilling or unable to commit the time required to issue the Surrosense Rx insole to five of their clients who choose to enrol in the study. iii. Unwilling to be monitored for fidelity. Exclusion criteria for participants i. Active foot ulcerations or previous transmetatarsal or more proximal foot amputations. ii. Cognitive or physical impairment that limits use of a smart insole. iii. Peripheral arterial disease with an Absolute Toe Pressure <60mmHg.