NCT03053245: m-CCRP

Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors

Completed NA Results posted Last updated 24 June 2024

What this trial tests

NA trial testing Mobile Critical Care Program in Acute Respiratory Failure in 503 participants. Completed in 31 October 2022.

Timeline

1 March 2017

Primary endpoint
31 October 2022

31 October 2022

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	503
Start date	1 March 2017
Primary completion	31 October 2022
Estimated completion	31 October 2022
Sites	3 locations across United States

Drugs / interventions tested

• Mobile Critical Care Program
• Attention Control

Conditions studied

• Acute Respiratory Failure — all drugs for Acute Respiratory Failure →
• Post-Intensive Care Syndrome — all drugs for Post-Intensive Care Syndrome →

Sponsor

Indiana University

Who can join

18 and older, any sex, with Acute Respiratory Failure or Post-Intensive Care Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Self Reported Quality of Life PCS: Physical Component Score at 1 Year Primary · 1 year

Utilizing SF-36 The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) consists of eight domains. It yields two summary scores (PCS: physical component score, and MCS: mental component score). MCS and PCS range from 0 to 100, and higher scores indicate better health status. A difference of 2 or more points is considered clinically meaningful for both the PCS and MCS subscales of SF-36.

Group	Value	95% CI
Mobile Critical Care Recovery Program	36.22	± 12.55
Attention Control	35.29	± 12.20

Self Reported Quality of Life MCS: Mental Component Score at 1 Year Primary · 1 year

Utilizing SF-36 The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) consists of eight domains. It yields two summary scores (PCS: physical component score, and MCS: mental component score). MCS and PCS range from 0 to 100, and higher scores indicate better health status. A difference of 2 or more points is considered clinically meaningful for both the PCS and MCS subscales of SF-36.

Group	Value	95% CI
Mobile Critical Care Recovery Program	49.81	± 11.75
Attention Control	51.12	± 10.23

Cognitive Assessment Score at 1 Year Primary · 1 year

Utilizing RBANS: Repeatable Battery for the Assessment of Neuropsychological Status. The overall RBANS z-score is the mean of the 7-item (RBANS subscale) z-scores that could be collected in person and by phone. The 7 subscales are: List Learning, Story Memory, Semantic fluency, Digit Span, List Recall, List Recognition, Story Recall. A Z-Score of 0 is the population mean. Values above 0 represent better outcomes.

Group	Value	95% CI
Mobile Critical Care Recovery Program	0.27	± 0.70
Attention Control	0.26	± 0.68

Depression Symptoms at 1 Year Secondary · 1 year

PHQ-9 (Patient Health Questionnaire-9) Scores range from 0 to 27 on the PHQ-9 with higher scores indicating greater severity of depression.

Group	Value	95% CI
Mobile Critical Care Recovery Program	5.94	± 6.13
Attention Control	5.66	± 5.37

Anxiety Symptoms at 1 Year Secondary · 1 year

GAD-7 (Generalized Anxiety Disorder-7) Scores range from 0 to 21 on the GAD-7 with higher scores greater anxiety.

Group	Value	95% CI
Mobile Critical Care Recovery Program	5.04	± 6.08
Attention Control	4.82	± 5.25

Physical Performance at 1 Year Secondary · 1 year

Utilizing SPPB The Short Physical Performance Battery (SPPB) will measure physical training effects on balance and strength. Ranges from 0-12: higher score is better outcome

Group	Value	95% CI
Mobile Critical Care Recovery Program	8.8	± 3.0
Attention Control	8.7	± 2.8

Sponsor's own description

The m-CCRP randomized controlled trial will evaluate the efficacy of a collaborative critical care recovery program from acute respiratory failure (ARF) survivors in accomplishing the Institute of Healthcare Improvement's triple aims of better health, better care, at lower cost.

Primary Aim:

To assess the efficacy of m-CCRP in improving the QOL of ARF survivors compared to attention control at twelve months post hospital discharge.

Secondary Aims:

1. To evaluate the efficacy of m-CCRP in improving cognitive, physical, and psychological function of ARF survivors at twelve months post hospital discharge when compared to attention control.
2. To evaluate the efficacy of m-CCRP in reducing health-care utilization, defined as time from enrollment to emergency department visits and/or hospital re-admission, by ARF survivors as compared to attention control at twelve months post hospital discharge.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mobile Critical Care Recovery Program for Survivors of Acute Respiratory Failure: A Randomized Clinical Trial.
   Khan BA, Perkins AJ, Khan SH, Unverzagt FW, et al · · 2024 · cited 15× · PMID 38289602 · DOI 10.1001/jamanetworkopen.2023.53158
2. Mobile critical care recovery program (m-CCRP) for acute respiratory failure survivors: study protocol for a randomized controlled trial.
   Khan S, Biju A, Wang S, Gao S, et al · · 2018 · cited 13× · PMID 29415760 · DOI 10.1186/s13063-018-2449-2
3. Performance of the Healthy Aging Brain Care Monitor Self Report in Monitoring Post-Intensive Care Syndrome Among Acute Respiratory Failure Survivors.
   Savsani PK, Khan SH, Perkins AJ, Wang S, et al · · 2025 · cited 1× · PMID 39526840 · DOI 10.1097/ccm.0000000000006522
4. Relationship Between ICU Delirium and Change in Quality of Life, Mood, and Cognition Over 12 Months in Survivors of Acute Respiratory Failure.
   Ferguson H, Sanjuan A, Perkins AJ, Elias M, et al · · 2026 · PMID 41938652 · DOI 10.1016/j.chstcc.2026.100242