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. 2021 Jun 9;21(12):3984. doi: 10.3390/s21123984

Table 2.

Study Tools.

Tool Description Trial Usage
Health Coaching Fidelity Assessment Tool The tool was developed by the researchers for this study. The fidelity elements assessed were aligned to the content of the training package outlined in Table 3 and the underlying transtheoretical model of behaviour change and social cognitive theories which underpinned the components of the skills taught to podiatrists [22,26,27,35]. Content validity was assessed by the health coach who delivered the intervention by comparing the domains of the tool to the health coaching training content. Face validity of the tool was then confirmed by two independent health coaches who provided feedback advising some alterations to phraseology be made. The changes were made, reviewed by the study health coach, and approved prior to finalisation of the tool. Audio recordings of the health coaching appointments were analysed and scored by the study health coach. Used to assess podiatrists’ fidelity in using health coaching techniques taught in phase 1 with participants in phase 2 consultations.
SurroSense Rx* insole manufacture by Orpyx Medical Technologies (Calgary, AB, Canada). Each SurroSense Rx* insole utilised 8 pressure sensors distributed to measure plantar foot pressures greater than 35 mmHg, and alert the wearer if pressures greater than 35 mmHg were sustained for 95 to 100% of the time in a 15 min sampling window on the same sensor [11]. Data and alerts were wirelessly transmitted from the transmission pod secured to the top of participants’ footwear to a smart watch worn by participants on the wrist. The smart watch stored data until upload to participants’ Orpyx Connect accounts. Alerts were provided to the wearer via the smart watch as vibration or audible alarms. The smart watch provided information regarding the site on the foot where pressures greater than 35 mmHg had been sustained, and provided instructions on how to off-load the pressure from the affected area.
A successful response to an alert was achieved if participants were able to reduce the pressure on the affected area within 3 min of the initial alert. Podiatrists were instructed to calibrate the sensors on the insoles for each participant at the time of issue, and check calibration at the 2-week review appointment.
SurroSense Rx* insole prospectively recorded hours of insole wear, numbers of alerts received by the user, and numbers of successful and unsuccessful responses to alerts during phase 2. These data were used to determine the degree to which participants adopted the smart insoles during the trial.
Nottingham Assessment of Function Footcare (NAFF) Questionnaire A 29-item validated questionnaire designed to measure self-reported footcare behaviours engaged in by people with diabetes related peripheral neuropathy [33]. Utilised pre and post phase 2. NAFF scores were used to assess association of the health coaching intervention with participants’ self-reported footcare behaviours.
Patient Interpretation of Neuropathy (PIN) Questionnaire Validated 39 item questionnaire designed to assess the perceptions of peripheral neuropathy of people with diabetes [32]. The tool utilises a 5-point Likert scale ranging from 1 as strongly disagree to 5 as strongly agree.
PIN Domains are as follows:
ID1: Good circulation equals healthy feet
ID2: Accurate interpretation of diabetes related peripheral neuropathy
ID3: Foot ulcers would be painful
C2: Blame of self or practitioner for peripheral neuropathy and associated consequences.
C1: Physical causes of foot ulcers
TL: Understanding of ulcer onset
CC1: Efficaciousness of foot self-care at preventing consequences of peripheral neuropathy
CC2: Degree of control that the practitioner has on foot ulcers
Cons: Possible consequences of peripheral neuropathy
EC1: Concern about possible consequences of peripheral neuropathy
EC2: Anger targeted towards practitioners related to peripheral neuropathy.
Utilised pre and post phase 2. PIN mean domain scores were used to assess association of health coaching intervention with participants’ interpretation of neuropathy.
UTAUT A version of the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaire [33]. The modified version of the UTAUT used in this study was validated for use in a health care context with both health providers and patients and contained 29 questions measured on a continuous 5-point Likert scale ranging for 0 as strongly disagree to 4 as strongly agree [34]. The questionnaire measured seven dependent psychosocial variables known to influence technology adoption: performance expectancy, effort expectancy, attitude, social influence, self-efficacy, anxiety, and facilitating conditions, and the independent outcome measure of behavioural intention.
In the context of this study, performance expectancy was the degree to which the individual believed that the smart insole would help them to prevent foot ulceration. Effort expectancy was how easy the individual found the smart insole to use in order to monitor their feet. Social influence was the degree to which significant others (e.g., family members, allied health professionals, clients) influenced the adoption of the smart insole. Self-efficacy was the degree to which the individual believed that they had the skills to adopt the smart insole. Facilitating conditions refers to the degree to which the individual believed that they had the capacity and infrastructure required to use the smart insole. Attitude was the individual’s feelings towards using the smart insole. Anxiety was the self-reported degree of anxiety or hesitation the individual experienced in relation to using the smart insole. Behavioural intention was the individual’s intention to use a smart insole over the 4-week period of the trial, and following conclusion of the trial, at some point in the future.
Utilised pre and post phase 2 to measure the impact of smart insole use on psychosocial factors impacting on behavioural intention to adopt the smart insole.