Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001276246
Ethics application status
Approved
Date submitted
5/07/2018
Date registered
27/07/2018
Date last updated
13/12/2021
Date data sharing statement initially provided
23/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
MyFootCare: a pilot study for a mobile application to engage patients with diabetic foot ulcers in self-care.
Scientific title
MyFootCare: a pilot study for a mobile application to engage patients with diabetic foot ulcers in self-care.
Secondary ID [1] 295380 0
Nil known
Universal Trial Number (UTN)
U1111-1216-7220
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 308613 0
Foot ulcer 308614 0
Condition category
Condition code
Metabolic and Endocrine 307564 307564 0 0
Diabetes
Skin 307565 307565 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To address the challenge of self care adherence in diabetic foot ulcer (DFU) management, the research team developed a mobile phone application (MyFootCare) designed to motivate and engage people with DFUs in their self-care. This project aims to determine the feasibility, usability and perceived value of using MyFootCare to engage patients in the self-care of their DFUs. The evaluation will be conducted in real-life settings, i.e., with patients using MyFootCare in their daily lives away from the clinic and with semi-structured interviews and observations at clinics to ensure ecological validity.

Participants will be provided with a study phone with MyFootCare installed. Orientation in the use of MyFootCare will be provided by the research team and ongoing technical support will be provided throughout the data collection period. Participants will be reminded by MyFootCare to change their ulcer dressing at regular intervals in between appointments with their treating clinician. They will be reminded to take a photo of the ulcer to track the ulcers' progress and to provide information on how they are feeling. All participants will use MyFootCare in addition to receiving standard evidence-based care. The study period will continue for 12 weeks or until the ulcer heals (whichever occurs first).

Interviews will be conducted with participants at three study points during the active data collection phase. These interviews will occur at the commencement of the trial period (week 0), at week three of the data collection period and at the conclusion of the study period (either when the ulcer heals or week 12). Direct observations of the interaction between the patient and their clinician will occur in week 3 and will focus directly on the dialogue of MyFootCare use.

Item 1. Name: MyFootCare, a mobile phone application for patients with diabetic foot ulcers (DFUs) and their carers to promote self-care away from the clinic.

Item 2. Why: MyFootCare seeks to promote self-care through digital images and self-reported symptoms, to enable patients to track their DFU healing progress. Furthermore, it highlights personal goals to help motivate patients and provides reminders to enact care on a regular basis

Item 3. What (materials): All patients will trial MyFootCare in addition to standard evidence-based care. Patients will be provided with a new smartphone for the study duration (12 weeks), with the MyFootCare app installed on it.

Item 4. What (procedures): Patients and carers will be asked to incorporate MyFootCare into their self-care practices by taking a DFU photo each time they change their wound dressing away from the clinic. Patients will receive reminders through the app to enact self-care and to take photos throughout the 12 week study period.

Item 5. Who provided: the research team will provide orientation and tuition on the functions of the mobile phone application for patients and their carers.

Item 6. How: the actual use of the mobile phone with the MyFootCare app installed on it.

Item 7. Where: away from the clinic, in patients' homes.

Item 8. When and how much: patients are encouraged to use the app to take a photo of their ulcer every time they change their wound dressing (typically every second day). Based on the photo, the app will provide patients with information about your healing progress.
Intervention code [1] 301701 0
Treatment: Devices
Intervention code [2] 301973 0
Behaviour
Comparator / control treatment
This study does not have a control/comparator treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306540 0
Qualitative and quantitative assessment of engagement with MyFootCare.
This is a composite primary outcome.
An Interview and Observation Guide has been specifically designed for this study to assess app engagement qualitiatively.
Quantitative assessment of app engagement will be determined through log data derived from the phone (ie usage frequency defined as number of app interactions, i.e., photos taken, per week).
Timepoint [1] 306540 0
At interview study points (week 0, week 3 and week 12).
Primary outcome [2] 306541 0
Qualitative assessment of usability of MyFootCare by patients and carers. Please note that this is a composite primary outcome.
An Interview and Observation Guide has been specifically designed for this study.
Timepoint [2] 306541 0
At interview study points (week 0 and week 3)
Primary outcome [3] 306542 0
Qualitative assessment of perceived usefulness of MyFootCare by patients and carers. Please note that this is a composite primary outcome.
An Interview and Observation Guide has been specifically designed for this study.
Timepoint [3] 306542 0
At interview study points (week 3 and week 12).
Secondary outcome [1] 348817 0
Qualitative assessment of perceived usefulness of MyFootCare during patient-clinician interaction. Please note that this is a composite primary outcome as rated by the patient, career and clinician.
An Interview and Observation Guide has been specifically designed for this study.
Timepoint [1] 348817 0
At interview study points (week 3)

Eligibility
Key inclusion criteria
1. Patients: adult (>18 years) patients with a diagnosis of type 1 or type 2 diabetes that are receiving treatment for a foot ulcer (defined as a full-thickness lesion of the skin below the malleoli of any duration). The patient or their carer, must also own a smartphone to ensure some familiarity with using photos and applications on smartphones to be eligible.
2. Carers: the adult carer identified by the patient to be the primary carer managing the patients ulcer.
3. Clinicians: the clinician (registered podiatrist, nurse or medical officer) identified by the patient to be the primary clinician managing the patients ulcer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Those patients, carers and clinicians unwilling or unable to provide consent to participate or undertake study procedures. An inability to provide consent includes a cognitive impairment or a low English language comprehension
2. Patients: those patients whose ulcer is expected to heal within 2 weeks upon commencement of the trial according to the clinician.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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
This is a pilot study, based on a qualitative approach, with a small convenience sample to explore the feasibility and perceived usefulness of MyFootCare for DFU self-care. The number of participants is determined by theoretical saturation, i.e., when the research team stop learning new things about how patients interact with and perceive MyFootCare. Based on the experience of the research team with qualitative evaluations of mobile apps in different health domains, we expect that 15-20 patients will be sufficient to reach data saturation. However, from experience we also know that about 20% of participants will stop using the app during the pilot study, and hence we aim to recruit up to 24 patients (and related carers and clinicians).

Qualitative analysis will be based on standard qualitative analysis techniques to address the research questions. They include:
1. Memoing: analytic memos will be produced immediately after data collection to generate initial codes on MyFootCare engagement, usability, self-care, and patient-clinician interaction, and to reflect on the method.
2. Coding: transcripts and field notes will be coded iteratively, by at least two research team members, using qualitative research software (NVivo), to organise the data and to compare different points of data for similarities and differences to create codes and to identify themes.
3. Inductive and deductive analysis: the analysis will based on themes emerging from the interview and observational data, as well as sensitising concepts from prior theory on mobile health app engagement and self-tracking.
4. Member checking: Our interpretation of the findings will be checked with patients, carers, and clinicians.
5. Thick descriptions: Reports and articles will present codes and themes as well as rich descriptions on app engagement and potential benefits on self-care to illustrate the findings.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
14/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11294 0
Chermside Community Health Centre - Chermside
Recruitment hospital [2] 11295 0
North Lakes Health Precinct - North Lakes
Recruitment hospital [3] 11296 0
Caboolture Community Health Centre - Caboolture
Recruitment hospital [4] 21312 0
Logan Hospital - Meadowbrook
Recruitment hospital [5] 21313 0
Browns Plains Community Health Centre - Hillcrest
Recruitment hospital [6] 21314 0
Eight Mile Plains Community Health Centre - Eight Mile Plains
Recruitment hospital [7] 21315 0
Inala Community Health Centre - Inala
Recruitment postcode(s) [1] 23183 0
4032 - Chermside
Recruitment postcode(s) [2] 23184 0
4509 - North Lakes
Recruitment postcode(s) [3] 23185 0
4510 - Caboolture
Recruitment postcode(s) [4] 36197 0
4131 - Meadowbrook
Recruitment postcode(s) [5] 36198 0
4118 - Hillcrest
Recruitment postcode(s) [6] 36199 0
4113 - Eight Mile Plains
Recruitment postcode(s) [7] 36200 0
4077 - Inala

Funding & Sponsors
Funding source category [1] 299971 0
University
Name [1] 299971 0
Queensland University of Technology
Country [1] 299971 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
2 George Street
Brisbane QLD 4000
Country
Australia
Secondary sponsor category [1] 299362 0
Government body
Name [1] 299362 0
Queensland Health - Metro North Hospital and Health Service
Address [1] 299362 0
The Prince Charles Hospital
Rode Road
Chermside QLD 4032
Country [1] 299362 0
Australia
Other collaborator category [1] 282088 0
Government body
Name [1] 282088 0
Queensland Health - Metro South Health and Hospital Service
Address [1] 282088 0
51 McKechnie Drive, Eight Mile Plains Community Health Centre, Eight Mile Plains, Queensland, 4113
Country [1] 282088 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300832 0
The Prince Charles Hospital Human Research Ethics Committee [EC00168]
Ethics committee address [1] 300832 0
The Prince Charles Hospital
Building 14
Rode Road
Chermside, QLD 4032
Ethics committee country [1] 300832 0
Australia
Date submitted for ethics approval [1] 300832 0
08/06/2018
Approval date [1] 300832 0
22/06/2018
Ethics approval number [1] 300832 0
HREC/18/QPCH/185

Summary
Brief summary
Diabetic foot ulcers (DFUs) are common, costly and take a toll on patients, families and communities. In Australia, the annual estimated expenditure exceeds $1.6 billion. Despite improved clinical management, effective treatment also relies on self-care away from the clinic. Unfortunately, adherence to self-care is typically low. To address this challenge, the research team developed a mobile phone application (MyFootCare) designed to motivate and engage people with DFUs in their self-care.

This project aims to determine the feasibility, usability and perceived value of using MyFootCare to engage patients in the self-care of their DFUs. Participants will include patients with a DFU, their carers and the treating clinicians. All patient participants will use MyFootCare in addition to receiving standard evidence-based care. This project is a predominantly qualitative study using interviews and direct observation, whilst collecting some quantitative measures via application usage log data. The expected outcome is a novel mobile application that seeks to engage patients with DFUs through goal-setting, progress monitoring and reminders to enact self-care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84962 0
Dr Bernd Ploderer
Address 84962 0
QUT School of Computer Science, Gardens Point, 2 George Street, Brisbane, QLD 4000
Country 84962 0
Australia
Phone 84962 0
+61731384927
Fax 84962 0
Email 84962 0
[email protected]
Contact person for public queries
Name 84963 0
Dr Bernd Ploderer
Address 84963 0
QUT School of Computer Science, Gardens Point, 2 George Street, Brisbane, QLD 4000
Country 84963 0
Australia
Phone 84963 0
+61731384927
Fax 84963 0
Email 84963 0
[email protected]
Contact person for scientific queries
Name 84964 0
Dr Bernd Ploderer
Address 84964 0
QUT School of Computer Science, Gardens Point, 2 George Street, Brisbane, QLD 4000
Country 84964 0
Australia
Phone 84964 0
+61731384927
Fax 84964 0
Email 84964 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
To protect the privacy of individuals


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.