NCT03800628

Brief Summary

The purpose of this qualitative study is to explore the vital issues in recovery of QOL from the perspective of survivors of critical illness and understand these patients' views on rehabilitative services in the United States (U.S.). The theoretical framework for this study is Max Weber's Rational Choice Theory (RCT). The research questions will focus on understanding post-ICU QOL and the patients' experience with rehabilitative services following critical illness. A phenomenological study design is being employed, using semi-structured individual interviews with critical illness survivors. Data from the interviews will be coded for thematic analysis. The implications for social change include defining the meaning of QOL for an ICU survivor and improving healthcare policies for the therapies necessary to return survivors to a life worth living.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

January 8, 2019

Last Update Submit

January 10, 2019

Conditions

Quality of Life

Keywords

survivorQOLresources

Outcome Measures

Primary Outcomes (1)

  • RQ1: What are the issues important to preserve quality of life from the perspective of critical illness survivors?

    semi-structured, open-ended qualitative interview

    6 months

Interventions

qualitative studyOTHER

semi-structured interviews

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

critical illness survivors

You may qualify if:

  • critical illness survivors within 18 months of ICU discharge
  • minimum 48 hours of mechanical ventilation
  • ability to read and understand English
  • over the age of 18

You may not qualify if:

  • emotional or psychological inability to participate in a 30-min interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Central Study Contacts

Michelle M McMoon

CONTACT

410-300-2786michelle.mcmoon@waldenu.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 11, 2019

Study Start

December 7, 2018

Primary Completion

June 30, 2019

Study Completion

August 30, 2019

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations

US(1)