Podiatrist-delivered health coaching to facilitate the use of a smart insole to support foot-health monitoring in people with diabetes-related peripheral neuropathy: a feasibility study.

Not Applicable

Completed

• Conditions: Diabetes related peripheral Neuropathy; Neurological - Other neurological disorders; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12618002053202
• Lead Sponsor: a Trobe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-21
• Study Completion: 2019-12-19
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Podiatrist Primary Outcomes<br>Fidelity to the health coaching technique in podiatrist-led appointment to issue the SurroSense Rx insole. Determined by qualitative audio analysis of recordings of each consultation. An experienced health coach will evaluation how health coaching techniques/strategies were utilised during the consultations.[Podiatrist Primary Outcome Timepoint<br>24 - 48 hours after the consultation with participants];Participant Outcomes<br>Utilisation of the smart insole measured in minutes per day as recorded by the SurroSense Rx insole system. Data to be downloaded from each device at the end of the intervention. <br>[Participant Primary Outcome Timepoint<br>4 weeks post-intervention]