MICU Recovery Clinic

NCT02560129 | Completed

• 1 other identifier: IRB00031295
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Summary: Emerging data demonstrate long-term morbidity and mortality in those who survive critical illness. However, there is no data regarding long-term follow-up for ICU survivors. The investigators have begun the implementation of an ICU recovery clinic. Rationale: ICU survivors are at high risk for functional, cognitive and psychiatric impairments. However, methods to mitigate these impairments and improve recovery are lacking. Special follow-up clinics for survivors of critical illness have been proposed and implemented to some degree, but are uncommon.

Conditions

Critical Illness; Sepsis; Respiratory Failure; ARDS

Keywords

recovery; ICU; clinic; survivor; physical function

Outcome Measures

Primary Outcomes (1)

• Physical Function

  as measured by the Short Performance Physical Battery

  6 months

Secondary Outcomes (9)

• Physical Function

  6 months

• Cognitive Function

  6 months

• Anxiety/ Depression Screening

  6 months

• Post Traumatic Stress Disorder Screening

  6 months

• Functional Status

  6 months

Other Outcomes (3)

• Swallow Function

  6 months

• Speech

  6 months

• Pain

  6 months

Study Arms (1)

ICU Survivors

ICU survivors will be seen in a MICU Recovery Clinic where Questionnaires, Physical and Cognitive Function assessments will be measured

Other: Questionnaires, Physical and Cognitive Function

Interventions

Questionnaires, Physical and Cognitive Function OTHER

ICU survivors will be administered a battery of questionnaires. Measurements of physical and cognitive function will also be performed.

ICU Survivors

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Wake Forest MICU Survivors

You may qualify if:

• sepsis OR
• respiratory failure requiring \>24 hrs of invasive mechanical ventilation
• previously functional

You may not qualify if:

• \- Active Malignancy

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Critical Illness; Sepsis; Respiratory Insufficiency

Interventions

Surveys and Questionnaires; Restraint, Physical

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Officials

• D. Clark Files, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: September 25, 2015
• Study Start: July 1, 2015
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

US (1)