Quality of LifeNCT03800628
Resource Availability Following Critical Illness
An observational study of Quality of Life, run by Walden University at 1 site in United States.
Trial 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.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- qualitative study
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2018to 30 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critical illness survivors
Who may be able to join
- 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
Who cannot join
- emotional or psychological inability to participate in a 30-min interview
- not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Rita Bakhru, MD, rbakhru@wakehealth.edu
Mary LaRose, RN, 336-716-4155, mlarose@wakehealth.edu
About this study
Official title: Perception of Quality of Life and Resource Availability After Surviving Critical Illness
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.
Read the detailed description
The purpose of this qualitative study is to understand the patient perception of QOL after surviving critical illness and how survivors can help illuminate gaps in current health policies to provide better recovery resources for this growing population.
The central research questions are:
RQ1: What are the issues important to preserve quality of life from the perspective of critical illness survivors? RQ2: How do survivors of critical illness describe rehabilitative services after discharge?
- Conditions
- Quality of Life
- Being tested
- qualitative study
- Keywords
- survivor, QOL, resources
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qualitative studyOther
semi-structured interviews
What is being measured
The primary outcome is the main question the study is designed to answer.
RQ1: What are the issues important to preserve quality of life from the perspective of critical illness survivors?
semi-structured, open-ended qualitative interview
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start7 Dec 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walden University
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Responsible party
- Principal investigator, Michelle McMoon, Walden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800628
- Sponsor's protocol ID
- 09-06-2018-0576535
- Status last verified
- Jan 2019
- First submitted
- 8 Jan 2019
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Quality of Life and Resource Availability After Surviving Critical Illness
- ClinicalTrials.gov ID
- NCT03800628
- Acronym / sponsor ID
- 09-06-2018-0576535
- Conditions
- Quality of Life
- Keywords
- survivor, QOL, resources
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Walden UniversityUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 11 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this qualitative study is to understand the patient perception of QOL after surviving critical illness and how survivors can help illuminate gaps in current health policies to provide better recovery resources for this growing population.
The central research questions are:
RQ1: What are the issues important to preserve quality of life from the perspective of critical illness survivors? RQ2: How do survivors of critical illness describe rehabilitative services after discharge?
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critical illness survivors
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- emotional or psychological inability to participate in a 30-min interview
- not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qualitative studysemi-structured interviews | Other | – |
Primary outcome
RQ1: What are the issues important to preserve quality of life from the perspective of critical illness survivors?
Time frame: 6 months
semi-structured, open-ended qualitative interview
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Walden University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle M McMoon (410-300-2786, michelle.mcmoon@waldenu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RQ1: What are the issues important to preserve quality of life from the perspective of critical illness survivors? (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.