NCT06440265

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

April 26, 2024

Last Update Submit

May 28, 2024

Conditions

Keywords

ICU acquired weaknessPost intensive care syndromeAM-PAC

Outcome Measures

Primary Outcomes (2)

  • 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

    enrollment day, 2week, 4week

  • 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.

    enrollment day, 2week, 4week

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may not qualify if:

  • Patients who were medically unstable to start rehabilitation in ICU or when mobilization was contraindicated by the medical team were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

postintensive care syndrome

Study Officials

  • Sung Eun Hyun, MD,PhD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor (MD, PhD), Department of Rehabilitation Medicine

Study Record Dates

First Submitted

April 26, 2024

First Posted

June 3, 2024

Study Start

March 31, 2023

Primary Completion

April 4, 2024

Study Completion

April 4, 2024

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations