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The feasibility of using the clinical health tracker app and web-interface to assess surgical risk in elective surgical patients.

The feasibility of using the clinical health tracker app and web-interface to assess peri-operative risk in elective surgical patients.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000811101
Enrollment
500
Registered
2019-06-04
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Summary The World Health Organisations International Classification of Function describes disability as the relationship between body function, activity levels and the level of participation. A patient’s level of disability has been shown to have adverse associations with surgical outcome. We have remotely measured patients’ activity and participation, continuously and objectively, using a cross platform smartphone application (app). The app reports step and Global Positioning System (GPS) data to a cloud database. Patients are generally accepting of this technology and show high levels of satisfaction with the process. We have used the data to generate meaningful outcomes for patients such as time spent at home and step counts. We have monitored patients prior to and following cardiothoracic surgery. These data will have a role in perioperative assessment. Currently perioperative assessment is performed using questionnaires and clinical assessment. These achieve a C-statistic for mortality prediction of 0.8-0.9. Machine learning techniques will enable the smartphone data to generate more accurate risk models for patients undergoing surgery and provide prediction for long-term patient-centred outcomes. Our objective is to assess the feasibility for a larger study. We intend to conduct a multicentre study enrolling 500 smartphone owning patients undergoing surgery at one of three centres in South Australia. Patients will receive a letter with instructions on how to install our app pre-operatively and be followed up for 90 days. We will report the time taken to achieve ethics and governance approval at each site and the number of patients who successfully activate the app at least seven days prior to surgery. We will report on the completeness of the step and GPS data from the individuals enrolled. We will use the data to power a larger study to predict days free from hospital at 90-days, time spent at home, daily step count and time spent inactive at 90-days. Plain English Statement Increasingly patients own smartphones. The multitude of sensors held in these devices allow for remote monitoring of patients. We believe that by using these data in a machine learning model, we will improve the prediction of risk of surgery, and also provide data on outcomes that are more meaningful to patients. We intend to assess the feasibility of using a smartphone app to monitor patients prior to and following surgery.

Interventions

This study aims to assess whether a cross platform smartphone app, the Clinical Health Tracker App which reports the location of the participant's phone every 5 minutes and reports step data from HealthKit (iOS) and Google Fit (Android) when the phone has a Wi-Fi connection connection. The data reported from the app can be used to derive several measures that assess a patient's level of activity and participation, which represent a patient's level of disability. This information on disability co

This study aims to assess whether a cross platform smartphone app, the Clinical Health Tracker App which reports the location of the participant's phone every 5 minutes and reports step data from HealthKit (iOS) and Google Fit (Android) when the phone has a Wi-Fi connection connection. The data reported from the app can be used to derive several measures that assess a patient's level of activity and participation, which represent a patient's level of disability. This information on disability could then potentially be used to predict surgical risk and outcome. To use the Clinical Health Tracker app, patients must own a smartphone. Patients will be provided with information on how to download and activate the app before surgery and how to remove it once the data is collected (3 months after discharge from hospital). This app is free to download from the app store. This app will be downloaded at least 2 weeks prior to surgery. The Clinical Health Tracker App does not require any training to use as it works in the background. There are surveys in the app that are activated by push activation that are used to reactivate the app should it stop sending data. Hence, the patient only needs to download the app onto their smartphone and leave the app on their phone- the app will report the step and GPS data automatically in the background for 3 months post surgery.

Sponsors

Samuel Gluck
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Undergoing elective surgery greater than 14 days from recruitment Aged over 18 Own a smartphone

Exclusion criteria

Refusal or inability to give informed consent Undergoing cardiothoracic surgery

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026