Critical IllnessPINANCT04186468
ICU Follow-up After Prolonged Intensive Care Stay
A study testing ICU follow-up clinic in people with Critical Illness and PICS, run by Otto-von-Guericke University Magdeburg at 3 sites in Germany.
Trial summary
Treatment in the intensive care unit (ICU) for more than five days often leads to chronic physical, cognitive and psychological complaints, such as post-traumatic stress disorders, muscle weakness, depression, anxiety and adjustment disorders. This is referred to as Post Intensive Care Syndrome (PICS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, PICS, Post Intensive Care Syndrome
- What is being tested?
- ICU follow-up clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesGermany
- Study dates
- 11 Jun 2020to 31 May 2021
- Phase
- Interventional
- 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
Who may be able to join
- duration of ICU stay more than five days
- sequential organ failure assessment score (SOFA) greater than five
- expected survival time greater than six months
- written informed consent
Who cannot join
- minor participants under the age of eighteen
- no written informed consent (unable or unwilling)
- unable to complete questionnaires
- insufficient German language skills
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Institute of Social Medicine and Health Systems Research
Magdeburg, 39120
Department for Epidemiology and Preventive Medicine
Regensburg, 93051
University Hospital
Regensburg, 93053
About this study
Official title: Piloting an ICU Follow-up Clinic to Improve Health Related Quality of Life After a Prolonged Intensive Care Stay
Treatment in the intensive care unit (ICU) for more than five days often leads to chronic physical, cognitive and psychological complaints, such as post-traumatic stress disorders, muscle weakness, depression, anxiety and adjustment disorders. This is referred to as Post Intensive Care Syndrome (PICS). So far, there have been only a few studies investigating this syndrome.
The aim of this pilot study is to test the effectiveness and feasibility of an ICU follow-up clinic, which our study team developed in a participatory process involving patients, caregivers, health care providers and researcher.
For this purpose, the participants will be randomly assigned to a group with treatment in this follow-up clinic or to a group with usual care. Both groups will then be compared.
Read the detailed description
Intensive care unit (ICU) survivors often suffer from cognitive, physical and psychological impairments, known as Post Intensive Care Syndrome (PICS). In order to improve healthcare of these patients in general and medical follow-up in particular, various aftercare models have been developed in different countries, including ICU follow-up clinics. So far, there is no uniform concept for an ICU follow-up clinic. Therefore, there is insufficient evidence whether or which concept of an ICU follow-up clinic is effective in addressing the health needs of ICU survivors. Within our study "Piloting an ICU Follow-up Clinic to Improve Health Related Quality of Life After a Prolonged Intensive Care Stay" (German abbreviation PINA), a concept for an ICU follow-up clinic was developed and will be tested in a pilot randomized controlled trial (RCT).
The study design comprises a pilot RCT with intervention and control (usual care) arms and an additional qualitative and quantitative process evaluation. One hundred ICU patients (fifty per arm) of three ICUs at University Hospital Regensburg will be enrolled as participants. Potential participants have to be older than eighteen years with an ICU stay of at least five days, a SOFA (sequential organ failure assessment) score greater than five and a life expectancy of more than six months.
The intervention aims at improving health-related quality of life and will contain three components: information, consultation and networking. More information (e.g. about sequelae after ICU, treatment options) will be available for the participants from the intensive care stay onwards, e.g. an information brochure, and during the entire follow-up period, e.g. by contacting the ICU follow-up clinic via telephone. Participants will be invited to visit the ICU follow-up clinic at least once during the first six months after discharge from ICU. During the visits, participants will be screened for symptoms of PICS and, if required, referred to specialists for further treatment. The aim of the networking part is to improve the exchange between the health sectors and disciplines involved in the treatment of the patients, e.g. through a special referral letter from the ICU follow-up clinic, and thus to provide a network of outpatient care providers for the former ICU patients.
Efficacy Outcomes: Health-related quality of life (HRQOL) will be assessed as primary outcome by the Short-Form-12 Questionnaire (SF-12). As secondary outcomes patient-reported outcomes regarding physical, psychological and social functioning are assessed. Additionally, HRQOL of next of kin is assessed. All outcomes are assessed at six months after discharge from ICU. Feasibility Outcomes: Qualitative and quantitative evaluation will be used for exploring reasons for non-participation and the intervention's acceptability to patients, caregivers and health care providers The PINA study will determine feasibility and efficacy of a complex intervention in a pilot RCT to enhance follow-up care of ICU survivors. The pilot study is an important step for further studies in the field of ICU aftercare and especially for the implementation of a pragmatic multicenter RCT.
- Conditions
- Critical Illness, PICS, Post Intensive Care Syndrome
- Being tested
- ICU follow-up clinic
- Keywords
- PICS, ICU, Intensive Care Unit, Post Intensive Care Syndrome, Follow-up clinic, Intensive care unit-acquired weakness, Critical illness polyneuropathy, Health-related quality of life, Critical care, Muscle weakness
- Medical subject headings
- Critical Illness, postintensive care syndrome, Polyneuropathies, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU follow-up clinicOther
The intervention aims at improving health-related quality of life and will contain three components: information, consultation and networking. More information will be available for the participants from the intensive care stay onwards, e.g. an information brochure, and during the entire follow-up period, e.g. by contacting the outpatient clinic via telephone. Participants will be invited to visit the ICU follow-up clinic at least once during the first six months after discharge from ICU. During the visits, participants will be screened for symptoms of PICS and, if required, referred to specialists for further treatment. The aim of the networking part is to improve the exchange between the health sectors and disciplines, e.g. through a special referral letter from the ICU follow-up clinic, and thus to provide a network of outpatient care providers for the former ICU patients.
| Study group | Role | What they receive |
|---|---|---|
| ICU follow-up clinic | Experimental | Participants will be invited to visit the ICU follow-up clinic. Receives: Other: ICU follow-up clinic |
| Usual care | No intervention | Participants will solely receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life, physical component summary score (HRQOL-PCS)
HRQOL will be assessed six months after discharge from the intensive care unit (ICU) by the Short Form-12 self-report questionnaire (SF-12) physical component summary score (PCS) (Ware, 1996). The German translation (Bullinger, 1998) will be used. Scores can range between zero and one hundred, with higher values indicating higher HRQOL.
Measured: Six months after ICU discharge
Secondary outcomes (8)
Health related quality of life, mental component summary score (HRQOL-MCS)
HRQOL will be assessed six months after discharge from the intensive care unit (ICU) by the Short Form-12 self-report questionnaire (SF-12) mental component summary score (MCS) (Ware, 1996). The German translation (Bullinger, 1998) will be used. Scores can range between zero and one hundred, with higher values indicating higher HRQOL.
Measured: Six months after ICU discharge
Activities of Daily Living (ADL)
ADL will be assessed by the Barthel-Index (Mahoney, 1965) in German translation (Lübke, 2004), which evaluates ten everyday functions. The degree of independence or care dependence can be assessed on a score ranging between zero (complete need for care) and one hundred points (independence).
Measured: Six months after ICU discharge
Chair Rise Test
The Chair Rise Test (Cooper, 2010 and Fuchs, 2013) will be used to assess participants' physical functioning. Anyone who cannot get up from a chair at normal height five times in a row in eleven seconds or less without supporting himself with his arms is considered to be at risk of falling.
Measured: Six months after ICU discharge
Hand Grip Strength
As an indicator for the general muscular strength (Beaton, 1995, Bobos, 2019), we will measure the hand grip strength with a dynamometer (Jamar Plus+ Digital Hand Dynamometer). Values can range fron zero to ninety kilogram, whereby higher values indicate a higher gripping force.
Measured: Six months after ICU discharge
Post-Traumatic Stress Syndrome 10-Questions Inventory (PTSS-10)
The PTSS-10 (Weisæth, 1989) will be used in the German translation (Maercker, 1998) to assess participants' risk of post traumatic stress disorders. Each symptom is rated from one (never) to seven (always). A total score of more than thirty-five predicts a likely diagnosis of post-traumatic stress disorder (PTSD).
Measured: Six months after ICU discharge
Short Form German Patient Health Questionnaire (PHQ-D)
The PRIME MD Brief Patient Health Questionnaire, PHQ (Spitzer, 1999) will be used in the German short form translation PHQ-D (Loewe, 2002) to assess psychopathological symptoms (anxiety, panic disorder or depression). Score values can range from zero to twenty-seven, with higher values being a good indicator for psychiatric diagnoses.
Measured: Six months after ICU discharge
Inpatient and outpatient health care utilization.
The extent of ambulatory and stationary health care use among the former ICU patients will be assessed by self-reported contacts with health services using a questionnaire as a proxy for morbidity. These contacts can range from zero to unlimited. A higher level of contacts indicates a weaker state of health.
Measured: Six months after ICU discharge
Health related quality of life (HRQOL) of next of kin
HRQOL of next of kin will be assessed also six months after discharge of the participant by the Short Form-12 self-report questionnaire (SF-12) PCS and MCS (Ware, 1996) after informed consent was obtained from the the respective relative. The German translation (Bullinger, 1998) will be used. Scores of both component scales can range between zero and one hundred, with higher values indicating higher HRQOL.
Measured: Six months after ICU discharge of the participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start11 Jun 2020
- Primary completion15 Mar 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The treatment group will supported by activities of an ICU follow-up clinic. The control group will receive usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto-von-Guericke University Magdeburg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Regensburg, University Hospital Regensburg
- Responsible party
- Principal investigator, Christian J. Apfelbacher, Otto-von-Guericke University Magdeburg
- Investigators
- Christian J Apfelbacher, Prof.Dr.PhD, Principal investigator, Otto-von-Guericke University Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186468
- Sponsor's protocol ID
- PINA-2019
- Other IDs
- VF_2016-076, 01VSF16056, 19-1522-101
- Acronym
- PINA
- Status last verified
- Nov 2022
- First submitted
- 2 Dec 2019
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PubMed 8628042MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950Fuchs J, Busch MA, Gosswald A, Holling H, Kuhnert R, Scheidt-Nave C. [Physical and cognitive capabilities among persons aged 65-79 years in Germany: results of the German Health Interview and Examination Survey for Adults (DEGS1)]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2013 May;56(5-6):723-32. doi: 10.1007/s00103-013-1684-7. German.
PubMed 23703491Cooper R, Kuh D, Cooper C, Gale CR, Lawlor DA, Matthews F, Hardy R; FALCon and HALCyon Study Teams. Objective measures of physical capability and subsequent health: a systematic review. Age Ageing. 2011 Jan;40(1):14-23. doi: 10.1093/ageing/afq117. Epub 2010 Sep 15.
PubMed 20843964Weisaeth L. Torture of a Norwegian ship's crew. The torture, stress reactions and psychiatric after-effects. Acta Psychiatr Scand Suppl. 1989;355:63-72.
PubMed 2624136Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
PubMed 10568646Beaton DE, O'Driscoll SW, Richards RR. Grip strength testing using the BTE work simulator and the Jamar dynamometer: a comparative study. Baltimore Therapeutic Equipment. J Hand Surg Am. 1995 Mar;20(2):293-8. doi: 10.1016/s0363-5023(05)80029-2.
PubMed 7775773Bobos P, Nazari G, Lu Z, MacDermid JC. Measurement Properties of the Hand Grip Strength Assessment: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2020 Mar;101(3):553-565. doi: 10.1016/j.apmr.2019.10.183. Epub 2019 Nov 13.
PubMed 31730754Bullinger M, Kirchberger I. Der SF-36 Fragebogen zum Gesundheitszustand (SF-36). Handbuch für die deutschsprachige Fragebogenversion Göttingen, Hogrefe, 1998.
Löwe B, Spitzer R, Zipfel S, Herzog W. PHQ-D Gesundheitsfragebogen für Patienten (German Version of the Patient Health Questionnaire). Karlsruhe: Pfizer, 2002.
Maercker, A. Posttraumatische Stress Skala-10 (PTSS-10) - deutsche Version modifiziert nach Schüffel u. Schade. Unveröffentlichtes Manuskript, Universität Zürich, Klinische Psychologie II, 1998.
Lubke N, Meinck M, Von Renteln-Kruse W. [The Barthel Index in geriatrics. A context analysis for the Hamburg Classification Manual]. Z Gerontol Geriatr. 2004 Aug;37(4):316-26. doi: 10.1007/s00391-004-0233-2. German.
PubMed 15338161Drewitz KP, Bernardi C, Pielmeier K, Brandstetter S, Rohr M, Brunnthaler V, Fisser C, Malfertheiner MV, Apfelbacher C. Piloting an ICU follow-up clinic - qualitative process evaluation alongside a feasibility study. Pilot Feasibility Stud. 2026 May 9;12(1):61. doi: 10.1186/s40814-026-01827-5.
PubMed 42104444Drewitz KP, Hasenpusch C, Bernardi C, Brandstetter S, Fisser C, Pielmeier K, Rohr M, Brunnthaler V, Schmidt K, Malfertheiner MV, Apfelbacher CJ. Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): feasibility of a pragmatic randomised controlled trial. BMC Anesthesiol. 2023 Oct 14;23(1):344. doi: 10.1186/s12871-023-02255-1.
PubMed 37838669Rohr M, Brandstetter S, Bernardi C, Fisser C, Drewitz KP, Brunnthaler V, Schmidt K, Malfertheiner MV, Apfelbacher CJ. Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): study protocol for a pilot randomised controlled trial. Pilot Feasibility Stud. 2021 Mar 30;7(1):90. doi: 10.1186/s40814-021-00796-1.
PubMed 33785064
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting an ICU Follow-up Clinic to Improve Health Related Quality of Life After a Prolonged Intensive Care Stay
- ClinicalTrials.gov ID
- NCT04186468
- Acronym / sponsor ID
- PINA / PINA-2019
- Conditions
- Critical Illness, PICS, Post Intensive Care Syndrome
- Keywords
- PICS, ICU, Intensive Care Unit, Post Intensive Care Syndrome, Follow-up clinic, Intensive care unit-acquired weakness, Critical illness polyneuropathy, Health-related quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Otto-von-Guericke University MagdeburgUniversity, hospital or other
- Collaborators
- University of Regensburg, University Hospital Regensburg
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 4 Dec 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.
Treatment in the intensive care unit (ICU) for more than five days often leads to chronic physical, cognitive and psychological complaints, such as post-traumatic stress disorders, muscle weakness, depression, anxiety and adjustment disorders. This is referred to as Post Intensive Care Syndrome (PICS). So far, there have been only a few studies investigating this syndrome.
The aim of this pilot study is to test the effectiveness and feasibility of an ICU follow-up clinic, which our study team developed in a participatory process involving patients, caregivers, health care providers and researcher.
For this purpose, the participants will be randomly assigned to a group with treatment in this follow-up clinic or to a group with usual care. Both groups will then be compared.
Detailed description
Intensive care unit (ICU) survivors often suffer from cognitive, physical and psychological impairments, known as Post Intensive Care Syndrome (PICS). In order to improve healthcare of these patients in general and medical follow-up in particular, various aftercare models have been developed in different countries, including ICU follow-up clinics. So far, there is no uniform concept for an ICU follow-up clinic. Therefore, there is insufficient evidence whether or which concept of an ICU follow-up clinic is effective in addressing the health needs of ICU survivors. Within our study "Piloting an ICU Follow-up Clinic to Improve Health Related Quality of Life After a Prolonged Intensive Care Stay" (German abbreviation PINA), a concept for an ICU follow-up clinic was developed and will be tested in a pilot randomized controlled trial (RCT).
The study design comprises a pilot RCT with intervention and control (usual care) arms and an additional qualitative and quantitative process evaluation. One hundred ICU patients (fifty per arm) of three ICUs at University Hospital Regensburg will be enrolled as participants. Potential participants have to be older than eighteen years with an ICU stay of at least five days, a SOFA (sequential organ failure assessment) score greater than five and a life expectancy of more than six months.
The intervention aims at improving health-related quality of life and will contain three components: information, consultation and networking. More information (e.g. about sequelae after ICU, treatment options) will be available for the participants from the intensive care stay onwards, e.g. an information brochure, and during the entire follow-up period, e.g. by contacting the ICU follow-up clinic via telephone. Participants will be invited to visit the ICU follow-up clinic at least once during the first six months after discharge from ICU. During the visits, participants will be screened for symptoms of PICS and, if required, referred to specialists for further treatment. The aim of the networking part is to improve the exchange between the health sectors and disciplines involved in the treatment of the patients, e.g. through a special referral letter from the ICU follow-up clinic, and thus to provide a network of outpatient care providers for the former ICU patients.
Efficacy Outcomes: Health-related quality of life (HRQOL) will be assessed as primary outcome by the Short-Form-12 Questionnaire (SF-12). As secondary outcomes patient-reported outcomes regarding physical, psychological and social functioning are assessed. Additionally, HRQOL of next of kin is assessed. All outcomes are assessed at six months after discharge from ICU. Feasibility Outcomes: Qualitative and quantitative evaluation will be used for exploring reasons for non-participation and the intervention's acceptability to patients, caregivers and health care providers The PINA study will determine feasibility and efficacy of a complex intervention in a pilot RCT to enhance follow-up care of ICU survivors. The pilot study is an important step for further studies in the field of ICU aftercare and especially for the implementation of a pragmatic multicenter RCT.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The treatment group will supported by activities of an ICU follow-up clinic. The control group will receive usual care.
| Arm | Type | Receives |
|---|---|---|
| ICU follow-up clinic | Experimental | Other: ICU follow-up clinicParticipants will be invited to visit the ICU follow-up clinic. |
| Usual care | No intervention | –Participants will solely receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- duration of ICU stay more than five days
- sequential organ failure assessment score (SOFA) greater than five
- expected survival time greater than six months
- written informed consent
Key exclusion criteria (4 listed)
- minor participants under the age of eighteen
- no written informed consent (unable or unwilling)
- unable to complete questionnaires
- insufficient German language skills
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 |
|---|---|---|
| ICU follow-up clinicThe intervention aims at improving health-related quality of life and will contain three components: information, consultation and networking. More information will be available for the participants from the intensive care stay onwards, e.g. an information brochure, and during the entire follow-up period, e.g. by contacting the outpatient clinic via telephone. Participants will be invited to visit the ICU follow-up clinic at least once during the first six months after discharge from ICU. During the visits, participants will be screened for symptoms of PICS and, if required, referred to specialists for further treatment. The aim of the networking part is to improve the exchange between the health sectors and disciplines, e.g. through a special referral letter from the ICU follow-up clinic, and thus to provide a network of outpatient care providers for the former ICU patients. | Other | ICU follow-up clinic |
Primary outcome
Health related quality of life, physical component summary score (HRQOL-PCS)
Time frame: Six months after ICU discharge
HRQOL will be assessed six months after discharge from the intensive care unit (ICU) by the Short Form-12 self-report questionnaire (SF-12) physical component summary score (PCS) (Ware, 1996). The German translation (Bullinger, 1998) will be used. Scores can range between zero and one hundred, with higher values indicating higher HRQOL.
8 secondary outcomes
Health related quality of life, mental component summary score (HRQOL-MCS)
Time frame: Six months after ICU discharge
Activities of Daily Living (ADL)
Time frame: Six months after ICU discharge
Chair Rise Test
Time frame: Six months after ICU discharge
Hand Grip Strength
Time frame: Six months after ICU discharge
Post-Traumatic Stress Syndrome 10-Questions Inventory (PTSS-10)
Time frame: Six months after ICU discharge
Short Form German Patient Health Questionnaire (PHQ-D)
Time frame: Six months after ICU discharge
Inpatient and outpatient health care utilization.
Time frame: Six months after ICU discharge
Health related quality of life (HRQOL) of next of kin
Time frame: Six months after ICU discharge of the participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Background: PubMed 8628042Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Background: PubMed 14258950MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
- Background: PubMed 23703491Fuchs J, Busch MA, Gosswald A, Holling H, Kuhnert R, Scheidt-Nave C. [Physical and cognitive capabilities among persons aged 65-79 years in Germany: results of the German Health Interview and Examination Survey for Adults (DEGS1)]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2013 May;56(5-6):723-32. doi: 10.1007/s00103-013-1684-7. German.
- Background: PubMed 20843964Cooper R, Kuh D, Cooper C, Gale CR, Lawlor DA, Matthews F, Hardy R; FALCon and HALCyon Study Teams. Objective measures of physical capability and subsequent health: a systematic review. Age Ageing. 2011 Jan;40(1):14-23. doi: 10.1093/ageing/afq117. Epub 2010 Sep 15.
- Background: PubMed 2624136Weisaeth L. Torture of a Norwegian ship's crew. The torture, stress reactions and psychiatric after-effects. Acta Psychiatr Scand Suppl. 1989;355:63-72.
- Background: PubMed 10568646Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.
- Background: PubMed 7775773Beaton DE, O'Driscoll SW, Richards RR. Grip strength testing using the BTE work simulator and the Jamar dynamometer: a comparative study. Baltimore Therapeutic Equipment. J Hand Surg Am. 1995 Mar;20(2):293-8. doi: 10.1016/s0363-5023(05)80029-2.
- Background: PubMed 31730754Bobos P, Nazari G, Lu Z, MacDermid JC. Measurement Properties of the Hand Grip Strength Assessment: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2020 Mar;101(3):553-565. doi: 10.1016/j.apmr.2019.10.183. Epub 2019 Nov 13.
- BackgroundBullinger M, Kirchberger I. Der SF-36 Fragebogen zum Gesundheitszustand (SF-36). Handbuch für die deutschsprachige Fragebogenversion Göttingen, Hogrefe, 1998.
- BackgroundLöwe B, Spitzer R, Zipfel S, Herzog W. PHQ-D Gesundheitsfragebogen für Patienten (German Version of the Patient Health Questionnaire). Karlsruhe: Pfizer, 2002.
- BackgroundMaercker, A. Posttraumatische Stress Skala-10 (PTSS-10) - deutsche Version modifiziert nach Schüffel u. Schade. Unveröffentlichtes Manuskript, Universität Zürich, Klinische Psychologie II, 1998.
- Background: PubMed 15338161Lubke N, Meinck M, Von Renteln-Kruse W. [The Barthel Index in geriatrics. A context analysis for the Hamburg Classification Manual]. Z Gerontol Geriatr. 2004 Aug;37(4):316-26. doi: 10.1007/s00391-004-0233-2. German.
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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.
Christian J Apfelbacher, Prof.Dr.PhD principal investigator
Otto-von-Guericke University Magdeburg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICU follow-up clinic in people with Critical Illness and PICS, run by Otto-von-Guericke University Magdeburg at 3 sites in Germany.
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 4 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: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life, physical component summary score (HRQOL-PCS) (time frame: Six months after ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04186468, which also lists 15 linked publications.
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 21 Nov 2022.