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Trial registered on ANZCTR


Registration number
ACTRN12622001565730
Ethics application status
Approved
Date submitted
7/12/2022
Date registered
19/12/2022
Date last updated
10/12/2023
Date data sharing statement initially provided
19/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of the impact of a telehealth program for the control of modifiable risk factors in people at risk of Diabetes-related Foot Disease
Scientific title
Assessment of the impact of a telehealth program for the control of modifiable risk factors in people at risk of Diabetes-related Foot Disease
Secondary ID [1] 308376 0
None
Universal Trial Number (UTN)
Trial acronym
The Tele-DFD trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Foot Disease 328185 0
Condition category
Condition code
Metabolic and Endocrine 325238 325238 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324840 0
Treatment: Drugs
Intervention code [2] 324841 0
Lifestyle
Intervention code [3] 324842 0
Behaviour
Comparator / control treatment
Standard of Care will be defined as the use of Clinical Guidelines and the medical practitioner's clinical judgement to provide care for their participants with Diabetes -related Foot Disease (DFD).. This may include the following: 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.
Control group
Active

Outcomes
Primary outcome [1] 333093 0
A composite outcome: the Diabetic Foot Disease (DFD) score. This score assigns a score based on the relative control of modifiable risk factors:
LDL-c and HbA1c assessed through blood test, systolic blood pressure assessed through automatic blood pressure monitor , anti-thrombotic therapy assessed through medical records and participant report, smoking status assessed through participant report and carbon monoxide testing, and percentage of time footwear worn and self-examination of the feet assessed using a orthotimer and participant report.

The minimum score is zero (worst control), and maximum score is seven (optimal control of each risk factor).
Timepoint [1] 333093 0
The primary timepoint will be 12 months post-enrolment. Additionally, primary outcome will also be tested at baseline and 6 months in order to assess the linear progression of effects in post study analyses.
Sample size for primary outcome was calculated using the linear mixed effects modelling with 80% power and alpha of 0.05 in the intervention group compared to usual care.
Secondary outcome [1] 415760 0
Participant engagement and satisfaction (Tele-DFD participants only) assessed through attendance at scheduled telehealth consultations and a custom-designed survey.

A subset of participants who complete the custom-designed survey will be selected for a semi-structured interview via telephone. The sub-set of participant will be those who consent to taking part in the interview
Timepoint [1] 415760 0
6 Months post-randomisation
Secondary outcome [2] 415761 0
Peripheral neuropathy assessed by using neuropathy total symptom score-6
Timepoint [2] 415761 0
Baseline and 12 month post-randomisation
Secondary outcome [3] 415762 0
Diabetic Food Disease complications including infection, ulceration and gangrene will be determined from participant's medical records
Timepoint [3] 415762 0
Baseline, 6 and 12 months post-randomisation
Secondary outcome [4] 415763 0
Lower limb amputations composite which includes minor amputations (any resection within the foot) and-or major amputations (any resection at or proximal to the ankle) determined from participant's medical records
Timepoint [4] 415763 0
Baseline, 6 and 12 months post-randomisation
Secondary outcome [5] 415764 0
Hospital admissions due to DFD determined from participant's medical records
Timepoint [5] 415764 0
Baseline, 6 and 12 months post-randomisation
Secondary outcome [6] 415765 0
Major adverse cardiovascular event such as myocardial infarction, stroke, cardiovascular related death, coronary or peripheral revascularization will be determined from medical records
Timepoint [6] 415765 0
Baseline, 6 and 12 month post-randomisation
Secondary outcome [7] 415766 0
Percentage of time footwear worn assessed using an orthotimer
Timepoint [7] 415766 0
Baseline, 6 and 12 months post-randomisation
Secondary outcome [8] 415767 0
Participant reported adherence will be assessed based on self-monitoring on footwear use, foot examination, prescribed medication, home blood pressure measurement and home blood glucose measurement
Timepoint [8] 415767 0
Baseline, 6 and 12 months post-randomisation
Secondary outcome [9] 415768 0
General quality of life assessed using SF-36
Timepoint [9] 415768 0
Baseline, 6 and 12 months post-randomisation
Secondary outcome [10] 415769 0
Exploratory circulating biomarkers in a subgroup of consenting participants assessed through blood samples.
Timepoint [10] 415769 0
Baseline, 6 and 12 month post-randomisation
Secondary outcome [11] 416893 0
Foot-specific quality of life using foot and ankle ability measure (FAAM) tool
Timepoint [11] 416893 0
Baseline, 6month and 12 month post-randomization

Eligibility
Key inclusion criteria
1) >18 years of age

2) Have a documented diagnosis of diabetes (HbA1C equal or greater than 6.5%)

3) 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;

4) Has a DFD score of less than 7

5) Willing to use smart phone, tablet or personal computer suitable for telehealth delivery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Has already achieved optimal risk factor control for DFD (DFD score of 7 at recruitment);

2) Unwilling or unable to engage with technology required for intervention (use of videoconferencing tools for remote counselling)

3) Involvement in another interventional trial

4) Terminal illness with a prognosis of less than 12 months;

5) Current active foot ulcer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed through use of an off-site randomisation service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be conducted using a secure, independent web-based minimization randomization system (Sealed Envelope). A random sequence for study arm allocation will be generated prior to commencement. Randomization will be in a 1:1 ratio between Tele-DFD and usual care group. Participant randomization will be done after the baseline visit when all relevant data has been received. Randomization will be stratified by study centre, gender and DFD score (<3, 3 to 4 and >4)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Using intention-to-treat (ITT) methodology, all randomised participants will be included in the primary analysis, and will be analysed according to their randomly allocated treatment as per the CONSORT guidelines. Statistical analyses will be conducted according to a detailed pre-specified data analysis plan which will be published separately prior to completion of the trial. Continuous outcomes will be compared using unpaired t-test or Mann Whitney U tests depending on data distribution. The hypothesis testing of the effect of Tele-DFD compared to usual care on continuous primary and other outcomes will be performed using mixed models using the interaction of time and group as test statistic. Models will be stratified using key clinical and social risk factors including age, sex, Aboriginal and Torres Strait Islander status, smoking status, presence of coronary heart
disease and peripheral artery disease, and HbA1c. For all binary outcomes, a time-to-event analysis will be conducted to test our hypothesis that Tele-DFD will reduce the primary endpoint. The hazard ratio (HR) and 95% CI will be calculated using the Cox proportional hazard analysis, and event risk will be plotted on a Kaplan-Meier graph. P-values <0.05 will be considered significant. Qualitative data from the surveys will analysed using content analysis to identify and quantify key concepts in relation to the acceptability of Tele-DFD.

Transcribed interviews will undergo thematic analysis independently by two research team members, involving deductive coding based on the program objectives. NVivo qualitative data analysis software will be used to assist in the analysis. Assessments of congruence (data triangulation) between the quantitative and qualitative findings will be conducted, to identify points of convergence and divergence between the datasets.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
12/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
142
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23544 0
Townsville University Hospital - Douglas
Recruitment hospital [2] 23545 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 23546 0
Townsville Aboriginal and Islander Health Service - Garbutt
Recruitment postcode(s) [1] 38963 0
4814 - Douglas
Recruitment postcode(s) [2] 38964 0
4029 - Herston
Recruitment postcode(s) [3] 38965 0
4814 - Garbutt

Funding & Sponsors
Funding source category [1] 312622 0
Hospital
Name [1] 312622 0
Townsville University Hospital
Country [1] 312622 0
Australia
Funding source category [2] 312637 0
University
Name [2] 312637 0
James Cook University
Country [2] 312637 0
Australia
Funding source category [3] 312638 0
Government body
Name [3] 312638 0
Cooperative Research Centre for Developing Northern Australia
Country [3] 312638 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
1 James Cook Drive, Townsville, QLD, 4811
Country
Australia
Secondary sponsor category [1] 314233 0
None
Name [1] 314233 0
Address [1] 314233 0
Country [1] 314233 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311941 0
Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 311941 0
Ethics committee country [1] 311941 0
Australia
Date submitted for ethics approval [1] 311941 0
15/08/2022
Approval date [1] 311941 0
27/09/2022
Ethics approval number [1] 311941 0
HREC/2022/QTHS/87079

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

Contacts
Principal investigator
Name 122914 0
Prof Jonathan Golledge
Address 122914 0
JCU Research Block, Ground Floor
Townsville University Hospital
100 Angus Smith Drive, Douglas, QLD, 4814
Country 122914 0
Australia
Phone 122914 0
+61 07 4781 4838
Fax 122914 0
Email 122914 0
[email protected]
Contact person for public queries
Name 122915 0
Jonathan Golledge
Address 122915 0
JCU Research Block, Ground Floor
Townsville University Hospital
100 Angus Smith Drive, Douglas, QLD, 4814
Country 122915 0
Australia
Phone 122915 0
+61 07 4781 4838
Fax 122915 0
Email 122915 0
[email protected]
Contact person for scientific queries
Name 122916 0
Jonathan Golledge
Address 122916 0
JCU Research Block, Ground Floor
Townsville University Hospital
100 Angus Smith Drive, Douglas, QLD, 4814
Country 122916 0
Australia
Phone 122916 0
+61 07 4781 4838
Fax 122916 0
Email 122916 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
Data will not be shared as this was not originally written in the study protocol. Our protocol does not have HREC approval for data sharing and this was not included in the PICF


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.