Evaluation of the change in health-related quality of life (HRQoL) and physical and mental health of critical illness survivors.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
herstel na kritische ziekte
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in health related quality of life measured with the 36-item short form
survey (SF-36) at baseline (from standard care clinical data), 3, 6 and 12
months.
Secondary outcome
Changes in physical health at baseline, 3, 6 and 12 months measured by:
- Quadriceps ultrasound parameters
- Bioimpedance measurements (baseline from standard care clinical data)
- Grip strength test dominant hand
- 6-Minute walking test + oximetry
- Morton Mobility Index
- Blood sample:
C-reactive protein (baseline from standard care clinical data)
Creatinine (baseline from standard care clinical data)
Haemoglobin (baseline from standard care clinical data)
Albumin (baseline from standard care clinical data)
Glucose non fasting (baseline from standard care clinical data)
Glutamine
Biomarkers for mitochondrial dysfunction
Changes in mental health at 3, 6 and 12 months, measured with:
- Short Fatigue Questionnaire (VVV)
- Hospital anxiety and depression scale (HADS)
- Coping inventory for stressful situations (CISS-21)
- Trauma screening questionnaire (TSQ)
- Happiness Index (HI)
- Cognitive functioning questionnaire (CFQ-25)
Dietary patterns post ICU, assessed with:
- Dietary history assessment during phone interview or house visit (if unable
to conduct through phone interview)
Background summary
Survival rates of patients with critical illness have increased due to improved
facilities and treatment methods in the intensive care unit (ICU). Despite
surviving critical illness, patients often face a difficult road of
rehabilitation after discharge from the ICU or the hospital ward. A large body
of evidence indicates that critical illness survivors suffer from physical and
mental health problems, reflected in a reduced health related quality of life.
However, detailed studies on longer-term outcomes and physical and mental
recovery are lacking. In order to develop a tailored aftercare interventional
program for critical care survivors a detailed description of the specific
health problems is necessary.
Study objective
Evaluation of the change in health-related quality of life (HRQoL) and physical
and mental health of critical illness survivors.
Study design
Prospective observational cohort study
Study burden and risks
Besides standard care at the ICU, all patients are subjected to bioimpedance
measurements, echography of the upper leg, physical tests (grip strength test,
Morton mobility index, 6 minute walking test with pulse oximetry), a total of
eight questionnaires of varying length, blood testing and interviews. The risks
and disadvantages of these tests are minimal. However, this study requires
considerable time investment and physical and mental effort. The extent of this
study is crucial to clarify the pathways of recovery in this specific patient
group. The findings of this study will be used to develop a suitable aftercare
intervention study. Patients that are admitted on the ICU are not always able
to give informed consent due to the severity of their illness. If this is the
case, deferred consent will be asked for the additional measurements conducted
in the ICU, i.e. echography of the upper leg and additional blood sampling from
a standard care arterial line, when the patient is able to give consent. At
that moment, further informed consent is asked for the remaining part of the
study. If the patient does not want to participate, all previously obtained
study data will be destroyed. The inclusion of these patients is essential,
because this research is specifically aimed at critically ill patients.
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Henri Dunantweg 2
Leeuwarden 8934 AD
NL
Listed location countries
Age
Inclusion criteria
>48 hours ICU stay
18 years old
Exclusion criteria
Not proficient in Dutch
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68263.099.18 |
| Other | Nummer volgt |