Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000546651
Ethics application status
Approved
Date submitted
13/04/2023
Date registered
22/05/2023
Date last updated
28/04/2024
Date data sharing statement initially provided
22/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Digital-powered healthcare: Optimising communication, engagement and treatment compliance in patients with implant-related infections
Scientific title
Investigating the effect of a digital health program on communication, engagement and treatment compliance in patients with implant-related infections
Secondary ID [1] 309446 0
Nil
Universal Trial Number (UTN)
Trial acronym
mDRIFT App
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma related infection 329698 0
Orthopaedic implant related infection 330015 0
Condition category
Condition code
Surgery 326599 326599 0 0
Other surgery
Infection 326925 326925 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study aims to determine the effectiveness of digital communication, wearable device and support pathways in improving communication, patient activation/engagement, and treatment compliance in patients with implant-related infections. This is a pilot non-randomised controlled trial with consecutive sampling. The efficacy acceptability and feasibility of the app-based communication tool will be assessed quantitatively and qualitatively. In addition, effectiveness of wearable device along with app will also be assessed in this cohort.
The intervention strategy will be based around delivery of a dynamic patient support pathway via an existing health communications platform, PEP Health, developed by Liquid State. The pathway will include a clinically aligned patient communications plan which will provide support and education content, feedback and progress surveys. The pathway will be responsive to patient journey changes and will facilitate the authorised sharing of information and patient progress between both professional and lay.
Participants in this study will be assigned into one of the three following groups (two intervention groups and a control group) for 3 months.
The intervention arm will be divided into two groups,
1. Group A will be provided Mobile App only (App only)
2. Group B will be provided Mobile app plus Xiaomi Mi Smart Band (App + Wearable device)
A mobile app will be downloaded in Group A and B patients’ smartphones, and they will receive emails, pop-up notifications, surveys, visual analogue scale (VAS) to score pain (from 0, none to 10, worst) and additional educational content through the app. The patients will be able to track digital care journey, that will allow them to understand treatment plan and how best to optimize health outcomes through active participation and self-monitoring. Automated responses to patient entered data allow the patient to understand how to interpret self-monitoring results and the direct link to the clinicians will allow for early intervention in the event of disease exacerbation. Patients will also be able to view their data in graphical and tabular form in their mobile app. A unique reward system based on gamification will also be used to improve the commitment and activation of patients in their recovery journey.
During routine multidisciplinary Device Related InFection Team (mDRIFT) clinic appointments at baseline, week-2, week-6, and 3-months, a research team members will ask Group A (App only) and B (App + Wearable device) participants to complete the following surveys using their mobile app:
• Participants’ knowledge, skill and confidence to manage their health and health care (Patient Activation Measure, PAM 13)
• Participants’ experiences of treatment and care (Australian Hospital Patient Experience Question Set, AHPEQS)
• Participants’ health-related questionnaire (EQ-5D-3L)
• Additionally, participants will receive pop-up notifications via the mobile App on their smartphone to record perceived pain on a scale from 0 (no pain) to 10 (worst pain) each week.
On average it will take between 30 and 40 minutes to complete surveys at each clinic visit and less than 5 minutes to record pain score every week at home. The overall duration of app usage time will vary. Apart from complete surveys, the use of the app will be at the participants' discretion. Throughout the study, a pathology request form, clinical appointment or follow-up, educational content or video will be sent through the app to encourage participants to use the app.
A Bluetooth enabled Xiaomi Smart Band 7 will be placed on the Group B (App + Wearable device) patients’ wrist. The Smart Band will record activity data generated by the sensors in real time, including heart rate, resting heart rate, sleep duration, steps, distance travelled and energy expenditure. The Smart Band app (Zepp Life) and Google Fit app will be downloaded in participants’ smartphones. Participants’ will be asked to charge the Band every three to four days. They will also be asked to open the Zepp Life and Google Fit Apps every day (preferably, or at least every two to three days) so that the app can automatically update the above-mentioned vitals. The Smart Band will be paired via Bluetooth to a third-party app (Zepp Life) which will be synced to Google Fit. Finally, the data from Google Fit will be transferred to the mDRIFT PEP Health Dashboard.
Intervention code [1] 325871 0
Treatment: Devices
Comparator / control treatment
Participants in the control group will ask you to complete the following traditional paper-based surveys during their routine clinic appointments at baseline, week-2, week-6, and 3-month -
• Pain score (Visual Analogue Scale)
• Participants' knowledge, skill and confidence to manage their health and health care (Patient Activation Measure, PAM 13)
• Participants' experiences of treatment and care (Australian Hospital Patient Experience Question Set, AHPEQS)
• Participants' health-related questionnaire (EQ-5D-3L)
Control group
Active

Outcomes
Primary outcome [1] 334449 0
Patient Activation (Self-care journey) will be assessed by Patient Activation Measure (PAM 13) via mobile app for intervention group and traditional paper-based surveys for control group.
Timepoint [1] 334449 0
Week-2, week-6, 3-month post-enrolment
Primary outcome [2] 334652 0
Patient experience will be assessed by Australian Hospital Patient Experience Question Set (AHPEQS) via mobile app for intervention group and traditional paper-based surveys for control group.
Timepoint [2] 334652 0
Baseline, week-2, week-6, 3-month post-enrolment
Primary outcome [3] 334653 0
Patient Recovery progress will be assessed by EQ-5D-3L through mobile app for intervention group and traditional paper-based surveys for control group.
Timepoint [3] 334653 0
Baseline, week-2, week-6, 3-month post-enrolment
Secondary outcome [1] 420739 0
Patient Empowerment within their care journey (the outcome is primary) will be assessed by Patient Activation Measure (PAM 13) via mobile app for intervention group and traditional paper-based surveys for control group.
Timepoint [1] 420739 0
Baseline, week-2, week-6, 3-month post-enrolment
Secondary outcome [2] 421535 0
Patient Injury Status will be assessed Injury Severity Score (ISS)
Timepoint [2] 421535 0
Baseline
Secondary outcome [3] 421536 0
Patient Engagement with the digital support channel (Intervention) will be assessed by Mobile app user engagement metrics (MixPanel), Compliance Rate (completed /provided surveys)
Timepoint [3] 421536 0
Week-2, week-6, 3-month post-enrolment.
Secondary outcome [4] 421537 0
Patient and Clinician Communication will be assessed by Australian Hospital Patient Experience Question Set (AHPEQS) and Patient Activation Measure (PAM 13).
Timepoint [4] 421537 0
Baseline, week-2, week-6, 3-month post-enrolment
Secondary outcome [5] 421538 0
Pain score (the outcome is primary) will be recorded using visual analogue scale via mobile app for intervention group and traditional paper-based surveys for control group.
Timepoint [5] 421538 0
Baseline and every week for 3 months for intervention groups; Baseline week-2, week-6, 3-month for control group.
Secondary outcome [6] 421539 0
Heart rate will be recorded via the Mi Smart Band 7
Timepoint [6] 421539 0
24/7 and recorded everyday.
Secondary outcome [7] 422051 0
Resting heart rate will be recorded via Mi Band 7
Timepoint [7] 422051 0
24/7 and recorded everyday.
Secondary outcome [8] 422052 0
Sleep duration and stages will be recorded via the Mi Smart Band 7
Timepoint [8] 422052 0
Every day during a night’s sleep
Secondary outcome [9] 422053 0
Steps will be recorded via the Mi Smart Band 7
Timepoint [9] 422053 0
24/7 and recorded everyday.
Secondary outcome [10] 422054 0
Distance walked will be recorded via the Mi Smart Band 7
Timepoint [10] 422054 0
24/7 and recorded everyday
Secondary outcome [11] 422055 0
Energy expended (calories) will be recorded via the Mi Smart Band 7
Timepoint [11] 422055 0
24/7 and recorded everyday

Eligibility
Key inclusion criteria
• Aged 18 years and over
• Patients with orthopaedic implant or trauma related infection
• Willingness and capacity to give informed consent
• Willingness to comply with study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients without an app-capable device
• Patients who do not consent to install the following apps (Android or iOS): mDRIFT, Zepp Life, and Google Fit on their app-capable device
• Patients who do not consent to using their internet data for mDRIFT app communication
• Patients who do not consent to wearing and using a health tracking device (Xiaomi Smart Band 7)
• Discharged from mDRIFT service at first review

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Every third participant will be assigned to the control group.
The following recruitment process will be used to randomise patients in to one of the three arms of this feasibility study. This pattern will continue until 48 patients have been recruited. There will be 16 patients per group.
Pt 1 App only
Pt 2 App + health tracking device
Pt 3 Control
Pt 4 App only
Pt 5 App + health tracking device
Pt 6 Control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The initial descriptive analysis will compare participants’ demographic, clinical and outcome characteristics between the intervention and comparator groups. This will include calculating percentages for categorical variables and mean or median values (with appropriate measures of variability) for continuous variables. Comparisons will be made using chi-square test, Fisher Exact test, two-sample T test, or Mann-Whitney U-test, as appropriate. Analysis of change scores, repeated measures and mixed regression models will explore differences in patient self-reported and clinical outcomes as well as clinicians’ experience, while adjusting for demographics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
28/10/2024
Actual
Date of last data collection
Anticipated
6/01/2025
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24513 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 40102 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 313643 0
Charities/Societies/Foundations
Name [1] 313643 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 313643 0
Australia
Funding source category [2] 313645 0
University
Name [2] 313645 0
Queensland University of TEchnology Centre for Biomedical Technologies Industry Engagement
Country [2] 313645 0
Australia
Primary sponsor type
Hospital
Name
Metro North Health
Address
Royal Brisbane and Women’s Hospital, Butterfield St, Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 315435 0
None
Name [1] 315435 0
Address [1] 315435 0
Country [1] 315435 0
Other collaborator category [1] 282625 0
University
Name [1] 282625 0
Queensland University of Technology
Address [1] 282625 0
Level 4, X Block

Kelvin Grove Campus

Victoria Park Rd
Kelvin Grove, QLD 4059
Country [1] 282625 0
Australia
Other collaborator category [2] 282626 0
Commercial sector/Industry
Name [2] 282626 0
Liquid State
Address [2] 282626 0
11b/96 Cleveland St, Greenslopes QLD 4120
Country [2] 282626 0
Australia
Other collaborator category [3] 282627 0
Hospital
Name [3] 282627 0
Royal Brisbane and Womens Hospital
Address [3] 282627 0
Level 7 Ned Hanlon Building
Butterfield Street
Herston QLD, 4029
Country [3] 282627 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312809 0
Metro North Health Human Research Ethics Committee
Ethics committee address [1] 312809 0
Ethics committee country [1] 312809 0
Australia
Date submitted for ethics approval [1] 312809 0
28/02/2023
Approval date [1] 312809 0
04/04/2023
Ethics approval number [1] 312809 0
HREC/2023/MNHA/92215

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

Contacts
Principal investigator
Name 126002 0
Dr William Steadman
Address 126002 0
RBWH Department of Orthopaedics
Level 7 Ned Hanlon Building
Butterfield Street
Herston QLD, 4029
Country 126002 0
Australia
Phone 126002 0
+61405612299
Fax 126002 0
Email 126002 0
[email protected]
Contact person for public queries
Name 126003 0
Arpita Das
Address 126003 0
Jamieson Trauma Institute
L13, Block 7, Royal Brisbane and Women’s Hospital,
Butterfield Street
HERSTON QLD 4029
Country 126003 0
Australia
Phone 126003 0
+61736460208
Fax 126003 0
Email 126003 0
[email protected]
Contact person for scientific queries
Name 126004 0
Beat Schmutz
Address 126004 0
Jamieson Trauma Institute
L13, Block 7, Royal Brisbane and Women’s Hospital,
Butterfield Street
HERSTON QLD 4029
Country 126004 0
Australia
Phone 126004 0
+61736461229
Fax 126004 0
Email 126004 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
This will not be available as per the conditions of our ethical approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18859Informed consent form    385736-(Uploaded-22-05-2023-14-16-52)-Study-related document.docx
19210Ethical approval    385736-(Uploaded-22-05-2023-14-17-29)-Study-related document.pdf



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.