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

Intensive Care Unit Acquired Weakness Clinical Trial

— AM-PAC  

Official title:

Validity and Reliability of Korean Version of Activity Measure for Post Acute Care (AM-PAC) Inpatient Short Form (Low Function) in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06440265
• Other study ID #: 2301-085-1395
• Status: Completed
• Start date: March 31, 2023
• Est. completion date: April 4, 2024

Study information

• Verified date: May 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 4, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Asthenia
• Critical Illness
• Intensive Care Unit Acquired Weakness
• Post Intensive Care Syndrome

Intervention

Other:
• AM-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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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