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CompletedNCT06440265AM-PACUpdated Jun 3, 2024

Validity and Reliability of Korean Version of AM-PAC Inpatient Short Form (Low Function) in Critically Ill Patients

An observational study in Post Intensive Care Syndrome and Intensive Care Unit Acquired Weakness, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-03.

Sponsored by Seoul National University Hospital · Observational

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Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
38
Ages
18 Years and older
Sex
All
01

Study summary

The Activity Measure for Post Acute Care (AM-PAC) inpatient short form (low function) evaluates the level of assistance a patient requires another person to provide for distinct functional mobility and daily activities. The objective of the study was to translate and cross-culturally adapt the AM-PAC (low function) into Korean version and assess its reliability and validity .

Independent raters assessed 38 patients from ICU using the Korean version of AM-PAC, respectively. Intra-class correlation coefficients (ICCs) and Bland-Altman's plots were used to evaluate reliability, and Cronbach's alpha for internal consistency. Validity was evaluated using Spearman's correlation analysis with other physical function assessment tools (functional status score for the ICU(FSS-ICU), Medical Research Council-sum score(MRC-SS), hand grip strength) and other unrelated factors (body mass index, glucose level).

Read the detailed description

The Activity Measure for Post Acute Care (AM-PAC) inpatient short form (low function) evaluates the level of assistance a patient requires another person to provide for distinct functional mobility and daily activities. The objective of the study was to translate and cross-culturally adapt the AM-PAC (low function) into Korean version and assess its reliability and validity.

An expert committee in intensive care unit (ICU) rehabilitation supervised the forward and backward translation process and to finalize the Korean version of AM-PAC (low function).

First evaluation of AM-PAC basic mobility and daily activity inpatient short forms was conducted on the first rehabilitation treatment day in ICU by the primary therapist. Subsequently, follow-up evaluations are conducted at 2 weeks and 4 weeks until the patient is discharged. Paired raters observed and recorded the scores independently. Each therapist was unaware of the other rater's scores, and they did not communicate verbally during the assessment. Starting with the first evaluation in the ICU, the same inter-rater reliability evaluation was performed in week 2 and week 4.

Raters assessed 38 patients from Medical ICU using the Korean version of AM-PAC. Intra-class correlation coefficients (ICCs) and Bland-Atman's plots were used to evaluate reliability, and Cronbach's alpha for internal consistency.

Then, convergent validity was evaluated using Spearman's correlation analysis between AM-PAC score and other physical function assessment tools (FSS-ICU, MRC-sum score, hand grip strength), and divergent validity was evaluated using correlation analysis between AM-PAC score and BMI or serum glucose level.

02

Conditions studied

  • Post Intensive Care Syndrome
  • Intensive Care Unit Acquired Weakness

Keywords

  • ICU acquired weakness
  • Post intensive care syndrome
  • AM-PAC
03

In context

postintensive care syndrome

106 studies on the registry are indexed under postintensive care syndrome; 49 are open to participants now.

This study's enrollment of 38 is below the median of 135 across 56 observational studies indexed under postintensive care syndrome.

Browse postintensive care syndrome studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

all patients above 18 years who were admitted to the Medical ICU and who are candidates of ICU rehabilitation, receiving the best care to recover from critical illness

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients above 18 years who were admitted to the Medical ICU and were expected to remain in the ICU for at least two days, were eligible for inclusion.

Exclusion criteria

Exclusion Criteria:

  • Patients who were medically unstable to start rehabilitation in ICU or when mobilization was by the medical team were excluded
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
38 participants (actual)
Patient registry
No

Interventions

  • OtherAM-PAC inpatient short form (low function)

    The Activity Measure for Post-Acute Care(AM-PAC) "6-clicks" instruments have advantages in that they are simple and quick to complete, easy to use within usual care and has been validated in the entire hospital population. It has gained broad adoption in acute care hospital and, although it includes items for people at lower levels of function, there is a concern of a floor effect in ICU measurement. So, new AM-PAC items are developed to measure physical function at the lowest level and added 2 new items to AM-PAC inpatient mobility short form. It lowered the floor effect and increased statistical power, measurement breath, and sensitivity. 2 new items * Turning head * Following simple instructions

06

What researchers measure

Primary outcomes

  1. Inter-rater reliability

    two-way, mixed effect intra-class correlation coefficient (ICC) and Bland Altman's plot between each independent, blinded rater's AM-PAC scores

    Time frame: enrollment day, 2week, 4week

  2. Concurrent Validity

    Convergent validity using Spearman's correlation analysis between AM-PAC score and FSS-ICU, MRC-sum score, hand grip strength; Divergent validity using Spearman's correlation analysis between AM-PAC score and body mass index(BMI) and serum glucose level which are irrelevant with functional status.

    Time frame: enrollment day, 2week, 4week

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in Apr 2024, 12 months.

Of 38 observational studies under postintensive care syndrome, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 50. This study's 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2024
First posted
Jun 3, 2024
StartActual
Mar 31, 2023
Primary completionActual
Apr 4, 2024
CompletionActual
Apr 4, 2024
Last update
Jun 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06440265
Responsible party
Sung Eun Hyun (assistant professor (MD, PhD), Department of Rehabilitation Medicine, Seoul National University Hospital) — Principal investigator
First posted
Jun 3, 2024
Start date
Mar 31, 2023
Primary completion
Apr 4, 2024
Completion
Apr 4, 2024
Last update
Jun 3, 2024

Study contacts

Sung Eun Hyun, MD,PhD
study chair · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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