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The feasibility and validity of obtaining pre-morbid activity data in critically ill patients using ‘smart-phone’ technology: a validation study - The PRE PED Study

The feasibility and validity of obtaining pre-morbid activity data in critically ill patients using ‘smart-phone’ technology: a validation study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616000427471
Enrollment
50
Registered
2016-04-04
Start date
2015-12-16
Completion date
2016-08-10
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

While impaired functioning has been shown to substantially influence quality of life for survivors of ICU in numerous studies, these studies are always limited as it has not been possible to objectively quantify patient’s pre-morbid function. This information is crucial as currently we cannot precisely quantify activity levels prior to their critical illness and, therefore, we cannot quantify the change in function for an individual patient. The ability to quantify change in functional ability would be a monumental advancement for researchers in other areas of medicine, but of pivotal importance in our field of critical care as researchers could then quantify the impact of intervention as a change in activity levels for an individual patient. Functional capacity after critical illness is an important outcome measure. Previously to determine functional capacity, researchers have focused on the six-minute walk test and questionnaires to quantify quality of life (QOL) and physical function. Such measures rely upon surrogates being used to subjectively assess pre-morbid functional capacity. There has never been a pre-morbid objective measurement and pedometers have never been used to assess physical activity following critical illness. The primary objective of this study is to establish feasibility of retrospectively obtaining pre-morbid pedometer/accelerometer and GPS data from the smart-phones of survivors of critical illness. The secondary objectives of this study are to validate accelerometer data extracted from a patient’s smart phone when they are recovering from critical illness. This will be achieved by comparison with pedometer data, which we will consider as the ‘gold standard’. In addition we will compare these data with data from a mobile phone app (MOVES) data, six-minute walk test, grip strength and functional assessment scores. These measurements of activity will be compared against measurements of function, i.e. the Functional independence measure (FIM), independent activities of daily living (iADLs), Activities of Daily Living (ADLs), extended Glasgow outcome scale (GOSE), Rivermead mobility index, (RMI) and EuroQoL05D-5L-35. Comparisons will be made at 3 and 6 months The tertiary objective of the study is to explore whether we can use GPS data extracted from the patient’s phone to construct activity or life space polygons to describe the recovery from critical illness at 3 and 6 months.

Interventions

This is a feasibility study to determine the ability to obtain data from patients smart phones, looking at data from the 28 days prior to ICU admission. Using information obtained from ICU patients smart phones, pre-hospital mobility will be assessed. This information will be compared to the patients status three and six months post ICU admission using a variety of assessment tools. This study will hopefully provide information about functional outcomes for patients based on pre-ICU status. Pati

This is a feasibility study to determine the ability to obtain data from patients smart phones, looking at data from the 28 days prior to ICU admission. Using information obtained from ICU patients smart phones, pre-hospital mobility will be assessed. This information will be compared to the patients status three and six months post ICU admission using a variety of assessment tools. This study will hopefully provide information about functional outcomes for patients based on pre-ICU status. Patients are admitted into the study after 48hrs admission into ICU and when they are able to give written informed consent which can occur in ICU or following discharge to the ward. Patients will be provided with a Fitbit and given instruction on how to download MOVES prior to the follow up visits at three and six months.

Sponsors

Dr Adam Deane
Lead SponsorIndividual

Eligibility

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

Inclusion criteria

(1) Ambulatory at baseline (pre-morbid) (walk for 10 minutes continuously or more) (2) They received >48 of mechanical ventilation (3) Aged > 18 years (4) Own a smart phone that has an accelerometer and reports GPS data.

Exclusion criteria

(1) Elective admission (2) Refusal of consent (3) Normal place of residence >50km from Adelaide (4) Long term inability to mobilise e.g. paraplegia, lower limb amputation, etc (5) Pregnancy (6) Inability to speak enough English to allow completion of telephone assessments. (7) They have cognitive or neurological deficits likely to impact their ability to complete the required assessments. (8) Expected death within 6 months.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026