Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002053202
Ethics application status
Approved
Date submitted
13/12/2018
Date registered
21/12/2018
Date last updated
28/06/2021
Date data sharing statement initially provided
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 295849 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes related peripheral Neuropathy 310846 0
Condition category
Condition code
Neurological 309521 309521 0 0
Other neurological disorders
Metabolic and Endocrine 309559 309559 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 312188 0
Treatment: Devices
Intervention code [2] 312189 0
Prevention
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307141 0
Podiatrist Primary Outcomes
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.
Timepoint [1] 307141 0
Podiatrist Primary Outcome Timepoint
24 - 48 hours after the consultation with participants
Primary outcome [2] 307142 0
Participant Outcomes
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.
Timepoint [2] 307142 0
Participant Primary Outcome Timepoint
4 weeks post-intervention
Secondary outcome [1] 350821 0
Podiatrist Secondary Outcomes
Time taken by podiatrist to issue the SurroSense Rx insole to the patient. This will be determined by analysing the audio recording of the consultation where minutes and seconds are recorded.
Timepoint [1] 350821 0
Day 1 of intervention
Secondary outcome [2] 350822 0
Podiatrist Secondary Outcomes
Time taken to provide follow-up podiatry intervention at 2 weeks as recorded on an Excel spreadsheet at the time of the consultation by the treating podiatrist.
Timepoint [2] 350822 0
2 weeks post participant intervention
Secondary outcome [3] 350823 0
Podiatrist Secondary Outcomes
Behavioural intention to adopt SurroSense Rx smart insoles into clinical practice following the intervention, measured by Unified Theory of Acceptance and Use of Technology (UTUAT) questionnaire.
Timepoint [3] 350823 0
5 Weeks post participant intervention
Secondary outcome [4] 350824 0
Podiatrist Secondary Outcomes
Identification of podiatrists’ enablers and barriers to adoption of SurroSense Rx smart insole into clinical practice determined by semi open-ended questions from UTAUT questionnaire and in-depth interviews.
Timepoint [4] 350824 0
5 Weeks post participant intervention
Secondary outcome [5] 350825 0
Participant Secondary Insole Outcomes
Number of alerts sent to participants from the SurroSense Rx insole system. The SurroSense Rx insole system records this data, which is then downloaded post-intervention for analysis.
Timepoint [5] 350825 0
0 -4 Weeks post participant intervention
Secondary outcome [6] 350826 0
Participant Secondary Insole Outcomes
Time taken for participants to respond to the alerts. This is recorded by the SurroSense Rx insole system. The data from each device will be downloaded at the end of the intervention for analysis.
Timepoint [6] 350826 0
0 - 4 Weeks post participant intervention.
Secondary outcome [7] 350827 0
Participant Secondary Insole Outcomes
Malfunctions of the smart insole. This will be recorded by the SurroSense Rx insole system, and participants will also be asked to contact the researchers if the device malfunctions. Details of the malfunction and resolution will be recorded on a spreadsheet and this data will be added to data provided by the smart-insole.
Timepoint [7] 350827 0
0 - 4 weeks post participant intervention
Secondary outcome [8] 350828 0
Participant Secondary Insole Outcomes
Method of follow-up consultation required for participants to use the SurroSense Rx insole. Recorded by the podiatrist on a spreadsheet.
Timepoint [8] 350828 0
2 Weeks post participant intervention.
Secondary outcome [9] 350829 0
Participant Secondary Outcomes
Occurrence of foot ulcerations determined by clinical assessment and graded according to WIfI wound classification system.
Timepoint [9] 350829 0
0-4 weeks post participant intervention
Secondary outcome [10] 350830 0
Participant Secondary Characteristic Outcomes
Identification of underlying participant foot health related behaviours and knowledge (composite outcome) via the Nottingham Assessment of Functional Footcare (NAFF) questionnaire, to determine if subgroups can be identified that correlate with SurroSense Rx insole utilisation.
Timepoint [10] 350830 0
Enrolment and 5 weeks post participant intervention.
Secondary outcome [11] 350831 0
Participant Secondary Characteristic Outcomes
The impact of actual SurroSense Rx insole usage on UTAUT questionnaire scores and behavioural intention.
Timepoint [11] 350831 0
0 and 4 Weeks post participant intervention
Secondary outcome [12] 350832 0
Participant Secondary Characteristic Outcomes
iii. Intention to adopt a SurroSense Rx insole following the 4 week trial as measured by Behavioural Intention mean score from UTUAT questionnaire at study completion.
Timepoint [12] 350832 0
4 Weeks post participant intervention
Secondary outcome [13] 350833 0
Participant Secondary Characteristic Outcomes
iv. Identification of participant barriers and enablers to adoption and utilisation of a SurroSense Rx insole determined by semi open-ended questions from UTAUT questionnaire and focus group interview.
Timepoint [13] 350833 0
5 weeks post participant intervention
Secondary outcome [14] 355083 0
Identification of underlying participant interpretation of neuropathy via the Patient Interpretation of Neuropathy (PIN) questionnaire, to determine if subgroups can be identified that correlate with insole utilisation.
Timepoint [14] 355083 0
Enrolment and 5 weeks post participant intervention.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A convenience sample of n = 10 participant will be recruited, 5 each from a public and private podiatry clinic. The sample size is limited due to limited resources; only 10 SurroSense Rx smart insoles will be purchased within allocated funding. Despite the small sample size, a rich array of data will be collected to determine feasibility, with added depth of understanding regarding issues of adoption and utilisation provided by the mixed-methods approach.

Descriptive statics will be used to report demographic data for participants. Ratio data will be presented as mean and standard deviation, and proportions will be used for nominal data. Statistical significance for analyses will be set at p<0.05.

Audio recordings of issue appointments will be listened to and assessed for fidelity to the use of the health coaching elements during the consultation. Fidelity will be scored by an experienced health coach into high, medium and low fidelity levels to health coaching elements and bivariate analysis and regression will be used to determine if the level of fidelity to health coaching impacts participant device usage as determined by minutes worn per day, number of alerts and number of alerts successfully responded to during the four-week intervention.

Cronbach’s alpha will be used to assess the internal consistency of the UTAUT responses. Mean domain scores measured on a continuous 5 point Likert scale for the UTAUT questionnaire will be calculated and bivariate analysis and linear regression will be used to determine the relationship between key psychosocial domains and behavioural intention both before and after using the smart insole for participants.

Relationships between key variables, such as NAFF and PIN scores and insole adoption as measured by the number minutes the insole is worn each day, the number of alerts provided from the insole, the number of alerts successfully responded to by participants will be analysed using bivariate analysis and linear regression.

Transcribed qualitative data from the focus groups and in-depth interviews will be analysed using thematic analysis. Line by line coding will be completed independently by two authors.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2019
Actual
16/07/2019
Date of last participant enrolment
Anticipated
29/04/2019
Actual
18/09/2019
Date of last data collection
Anticipated
3/06/2019
Actual
19/12/2019
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11690 0
Goulburn Valley Health - Shepparton campus - Shepparton
Recruitment postcode(s) [1] 23766 0
3630 - Shepparton

Funding & Sponsors
Funding source category [1] 300448 0
University
Name [1] 300448 0
La Trobe University
Country [1] 300448 0
Australia
Funding source category [2] 300449 0
Commercial sector/Industry
Name [2] 300449 0
Orpyx Medical Technologies
Country [2] 300449 0
Canada
Primary sponsor type
University
Name
La Trobe
Address
Bundoora, Victoria, 3086, AUSTRALIA
Country
Australia
Secondary sponsor category [1] 299913 0
None
Name [1] 299913 0
Address [1] 299913 0
Country [1] 299913 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301249 0
Goulburn Valley Health
Ethics committee address [1] 301249 0
Ethics committee country [1] 301249 0
Australia
Date submitted for ethics approval [1] 301249 0
28/01/2019
Approval date [1] 301249 0
15/04/2019
Ethics approval number [1] 301249 0
Ethics committee name [2] 301250 0
La Trobe University Human Ethics Committee
Ethics committee address [2] 301250 0
Ethics committee country [2] 301250 0
Australia
Date submitted for ethics approval [2] 301250 0
25/02/2019
Approval date [2] 301250 0
Ethics approval number [2] 301250 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86370 0
A/Prof Michael Kingsley
Address 86370 0
La Trobe Rural Health School
College of Science, Health and Engineering,
La Trobe University,
Flora Hill Campus,
Bendigo, Victoria, 3550
Country 86370 0
Australia
Phone 86370 0
+61 3 5444 7589
Fax 86370 0
+61 3 5444 7977
Email 86370 0
[email protected]
Contact person for public queries
Name 86371 0
Michael Kingsley
Address 86371 0
La Trobe Rural Health School
College of Science, Health and Engineering,
La Trobe University,
Flora Hill Campus,
Bendigo, Victoria, 3550
Country 86371 0
Australia
Phone 86371 0
+61 3 5444 7589
Fax 86371 0
+61 3 5444 7977
Email 86371 0
[email protected]
Contact person for scientific queries
Name 86372 0
Michael Kingsley
Address 86372 0
La Trobe Rural Health School
College of Science, Health and Engineering,
La Trobe University,
Flora Hill Campus,
Bendigo, Victoria, 3550
Country 86372 0
Australia
Phone 86372 0
+61 3 5444 7589
Fax 86372 0
+61 3 5444 7977
Email 86372 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will use de-identified data in all reports


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12292Study protocol  [email protected]



Results publications and other study-related documents

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