RecruitingACTRN12622001565730

Assessment of the impact of a telehealth program for the control of modifiable risk factors in people at risk of Diabetes-related Foot Disease


Sponsor

James Cook University

Enrollment

142 participants

Start Date

Jul 12, 2023

Study Type

Interventional

Conditions

Summary

Diabetes-related foot disease (DFD), such as ulcers, infection or gangrene, causes ~30,000 hospital admissions and ~4,500 amputations (the highest global amputation rate) at a cost of ~$2 billion a year in Australia. The key risk factors leading to DFD are driven by hyperglycemia, high blood pressure and dyslipidemia. Tele-DFD is a one-year prospective, randomised, multi-centre trial aimed to improve modifiable risk factor control measured based on improvement in DFD-score following Tele-DFD intervention. 142 participants with moderate or high risk of diabetic foot disease will be consented and recruited to this trial. In this RCT, usual care is compared to Tele-DFD with participants randomly allocated to one of the following groups: Usual care, where participants will receive standard care by participants' general practitioners for regular clinical monitoring, endocrinologists for risk factor control, and face-to-face consulting in the outpatient clinics for support and ongoing monitoring of patient’s health and prognosis. Tele-DFD will use an integrated multi-disciplinary approach via a technology-facilitated prevention program consisting of remote medical management, remote footwear management and foot health monitoring, education and behaviour change support to optimise DFD risk factors. The primary outcome will be a change in DFD score with secondary outcomes looking at quality of life, participant engagement and satisfaction, cardiovascular event and DFD complications


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria5

  • >18 years of age
  • Have a documented diagnosis of diabetes (HbA1C equal or greater than 6.5%)
  • Be at moderate or high risk of DFD, defined according to the IWGDF 2019 as risk score greater than or equal to 2. This includes having loss of protective sensations in the feet (LOPS) and peripheral artery disease (PAD) or foot deformity or have previously experienced DFD (foot ulcer, gangrene, foot infection, minor or major amputation) or have end-stage renal disease;
  • Has a DFD score of less than 7
  • Willing to use smart phone, tablet or personal computer suitable for telehealth delivery

Exclusion Criteria5

  • Has already achieved optimal risk factor control for DFD (DFD score of 7 at recruitment);
  • Unwilling or unable to engage with technology required for intervention (use of videoconferencing tools for remote counselling)
  • Involvement in another interventional trial
  • Terminal illness with a prognosis of less than 12 months;
  • Current active foot ulcer.

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Interventions

The intervention will consist of three core elements aimed to improve diabetic foot disease risk factors: (a)Medical management: This will be provided by a specialist endocrinologist and his study

The intervention will consist of three core elements aimed to improve diabetic foot disease risk factors: (a)Medical management: This will be provided by a specialist endocrinologist and his study nurse to achieve optimal control of diabetes (HbA1c <8%), cholesterol (LDL-C <1.8mmol/L), smoking status (quitting) and blood pressure (<130/85mmHg) through a tailored monitor and management plan. These sessions will be delivered remotely through the Queensland health portal directly to participant’s ipad provided by study team. The telehealth sessions will be 30mins long and occur every 6 weeks via telehealth for 12 months. Participant who have risk factors that do not meet optimum guidelines will receive medical management for areas that they are deficient in. Glucometers and blood pressure measuring device will be supplied to participants by trial team and advised to record blood glucose and blood pressure measurements in a self-reported log book. Study nurse will use this information for optimising drug dosage. Participant’s current medications for lowering blood pressure, blood glucose, LDL-C and antithrombotic therapy will be reviewed and optimized by either changing the generic drug or altering dosage to bring clinical risk factors under control. In participants who currently smoke, they will be offered smoking cessation counselling and Varenicline or nicotine replacement therapy if suitable. Smoking cessation counsellors will be trained in using 5As approach by a clinical psychologist. Smoking cessation sessions will be determined based on individual needs and will be offered in addition to the medical management sessions. (b) Remote footwear management and foot health monitoring This program will be managed by trial coordinator through monthly phone call. Participant’s footwear use habit will be monitored for 7 days at baseline, 6 month and 12 month visits using two devices in conjunction; Orthotimer which measures foot temperature and Actigraph which measures physical activity. After 7 days the devices will be collected from participants and percentage of time footwear was worn will be established. The ideal time spent wearing footwear should be greater than 70% of active hours spent indoors and outdoors. Active hours includes the time spent walking, standing or sitting. Participants will not be required to wear footwear when lying down. Therapeutic footwear will not be provided to participants if they do not already have their own. Participants will be encouraged to wear either pressure offloading therapeutic footwear or normal footwear (i.e. off the shelf) that they find comfortable, when active. Foot health monitoring includes self-examination of feet and hot spots check using TempStat which takes approximately 15 minutes to complete. Self-examination of the feet procedures based on IWGDF 2019 guidelines on prevention of foot ulcers will be taught to participants during enrolment. Also a TempStat device from Arche healthcare which measures plantar surface temperature capable of indicating hot spots (inflammation spots) will be supplied to participants. If a hot spot is noticed which is an indication of ulcer formation, they will be advised to reduce activity and visit their general practitioner. Compliance will be monitored through self-reported log book and feedback given by both study nurse and study counsellor. The self-reported log book or diary will be provided to participants to record daily; self-examination of feet, use of TempStat and approximate amount of time footwear is worn. Detailed instructions on using all devices and keeping the log book will be given to participants randomized to intervention group by trial coordinator. (c) Counselling and behaviour change support A counselling program based on 5As methods of behaviour change tailored to individual needs will be provided through Queensland tele health portal remotely by counsellors trained by a clinical psychologist. These sessions will be scheduled for 30 minutes every 6 weeks over 12 months. The comprehensive counselling sessions will attempt to improve participant’s ability to self-manage their medical condition through self-monitoring their blood glucose, blood pressure, foot temperature, wearing footwear to protect their feet as recommended and taking medications regularly. Compliance will be monitored through self-reported log book use and percentage of time footwear worn values recorded at baseline, 6 months and 12 months. When compliance is not achieved, counsellors will address any barriers, offer solutions and provide in meeting goals. The counselling program will be designed to improve attendance and compliance across all three components through education and positive behaviour change. Attendance across the three interventions, (i.e.) telehealth sessions by endocrinologist or study nurse, monthly phone calls by trial coordinator and telehealth sessions by study counsellor will be logged in the trial database. During 6 month and 12 month visits log books will be collected to assess proper use and record compliance.


Locations(3)

Townsville University Hospital - Douglas

QLD, Australia

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

Townsville Aboriginal and Islander Health Service - Garbutt

QLD, Australia

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ACTRN12622001565730


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