Intensive Care (ICU) PatientsRAPITNCT01721239
Recovery and Aftercare in Post Intensive Care Therapy Patients - RAPIT Study
A study testing Standardized Followup program in people with Intensive Care (ICU) Patients, run by Hillerod Hospital, Denmark at 1 site in Denmark.
Trial summary
In 2010 alone were admitted 33,361 patients for treatment in Danish intensive care units. There is evidence to former intensive care patients have a significant symptom burden that affect recovery, function and activity for up to several years after admission to the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care (ICU) Patients
- What is being tested?
- Standardized Followup program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2012to Oct 2016
- 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
- Age ≥ 18 years
- Non-invasive or invasive ventilation ≥ 48 hours (Non-invasive ventilation (NIV) from current guidelines).
- APACHE II score ≥ 12 ≤ 29
- Unrecognized dementia diagnosis
Who cannot join
- Delirium at randomization (Positive CAM-ICU score)
- Participation in scientific projects which include patient interviews
- Not Speak and understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recovery and Aftercare in Post Intensive Care Therapy Patients - The RAPIT Study. The Effectiveness and Experiences of a Follow-up Program for Danish Mechanically Ventilated ICU Patients: A Pragmatic Randomized Controlled Multicentre Trial.
In 2010 alone were admitted 33,361 patients for treatment in Danish intensive care units. There is evidence to former intensive care patients have a significant symptom burden that affect recovery, function and activity for up to several years after admission to the intensive care unit. For the individual patient involves the low quality of life, delayed recovery, prolonged illness and healing process, and increased mortality. It requires that health professionals should provide support so patients quicker return to their usual life. Follow-up interviews with the staff after hospitalization in ICU have been shown to support the patient and identify individual needs and symptoms that can lead to more realistic expectations and increased well-being after admission in ICU. Follow-up in Denmark is being inconsistent in both the number of hospitals that offer this service, and in the offered type of service. Follow-up interviews with and without diaries suggest to improve physical and mental well-being and health, with limited scientific evidence of the efficacy of these interventions. We will investigate the effect of a standardized follow-up program after admission to the intensive care unit, consisting of written information, patient photos taken during hospitalization and three follow-up calls compared with standard care (discharge without follow-up).
During a clinical study conducted in several intensive care units in Denmark examined whether follow-up calls can improve patients' well-being and health, as well as the meaning of the follow-up program has on the patient's everyday life in the first year after hospitalization in the ICU.
The investigation contribute knowledge to the international research by revealing symptom burden and efficacy of a follow-up program for up to 1 year after admission to the ICU in order to be able to target rehabilitation efforts and improved the quality of life. It will be innovative to use the results from a clinical study as a foundation for a database, and the method can serve as a precedent for evidence-based introduction of guidelines, database registration and create the groundwork for future research in intensive care. This study is expected to be profitable to society by preventing frequent readmissions, reduce medication costs and fewer referrals to specialists and have a positive effect on retention to the labor market. This will provide overall better use of society's expenses.
- Conditions
- Intensive Care (ICU) Patients
- Being tested
- Standardized Followup program
- Keywords
- ICU, Follow-up consultations, Quality of life, Sense Of Coherence, RCT multicenter study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Followup programOther
Standardized written information, patient photos and three followup consultations.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention |
| Standardized Followup program | Experimental | Standardized written information, patient photos and three follow-up consultations. Receives: Other: Standardized Followup program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to quality of life, on the mental component of the instrument, SF-36 Intension-to-treat analysis
Measured: 12 months
Secondary outcomes (5)
Symptom Scores
Changes in score regarding symptoms scores in control and intervention groups.
Measured: 12 months
Baseline data
baseline data concerning patient's demographic and clinical data
Measured: At randomization
Symptom score
Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to symptom scores.
Measured: 12 months
Depression
Changes in score regarding depression in control and intervention groups
Measured: 12 months
Sense of Coherence
Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to sense of coherence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2012 (estimated)
- Study start1 Dec 2012
- Primary completionFeb 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care (ICU) PatientsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillerod Hospital, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, Copenhagen University Hospital, Rigshospitalet, Nykøbing Falster County Hospital, Odense University Hospital, Sonderborg Hospital, Region of Southern Denmark, Regionshospitalet Horsens, Naestved Hospital
- Responsible party
- Principal investigator, Janet Froulund Jensen, Hillerod Hospital, Denmark
- Investigators
- Janet F Jensen, PhD-student, Principal investigator, Hillerod Hospital, department of Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721239
- Sponsor's protocol ID
- HIH-01863-2012-011
- Acronym
- RAPIT
- Status last verified
- Apr 2018
- First submitted
- 31 Oct 2012
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jensen JF, Egerod I, Bestle MH, Christensen DF, Elklit A, Hansen RL, Knudsen H, Grode LB, Overgaard D. A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study. Intensive Care Med. 2016 Nov;42(11):1733-1743. doi: 10.1007/s00134-016-4522-1. Epub 2016 Sep 30.
PubMed 27695894
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery and Aftercare in Post Intensive Care Therapy Patients - The RAPIT Study. The Effectiveness and Experiences of a Follow-up Program for Danish Mechanically Ventilated ICU Patients: A Pragmatic Randomized Controlled Multicentre Trial.
- ClinicalTrials.gov ID
- NCT01721239
- Acronym / sponsor ID
- RAPIT / HIH-01863-2012-011
- Conditions
- Intensive Care (ICU) Patients
- Keywords
- ICU, Follow-up consultations, Quality of life, Sense Of Coherence, RCT multicenter study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Hillerod Hospital, DenmarkUniversity, hospital or other
- Collaborators
- Herlev Hospital, Copenhagen University Hospital, Rigshospitalet, Nykøbing Falster County Hospital, Odense University Hospital, Sonderborg Hospital, Region of Southern Denmark, Regionshospitalet Horsens, Naestved Hospital
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Nov 2012 (estimated)
- 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.
In 2010 alone were admitted 33,361 patients for treatment in Danish intensive care units. There is evidence to former intensive care patients have a significant symptom burden that affect recovery, function and activity for up to several years after admission to the intensive care unit. For the individual patient involves the low quality of life, delayed recovery, prolonged illness and healing process, and increased mortality. It requires that health professionals should provide support so patients quicker return to their usual life. Follow-up interviews with the staff after hospitalization in ICU have been shown to support the patient and identify individual needs and symptoms that can lead to more realistic expectations and increased well-being after admission in ICU. Follow-up in Denmark is being inconsistent in both the number of hospitals that offer this service, and in the offered type of service. Follow-up interviews with and without diaries suggest to improve physical and mental well-being and health, with limited scientific evidence of the efficacy of these interventions. We will investigate the effect of a standardized follow-up program after admission to the intensive care unit, consisting of written information, patient photos taken during hospitalization and three follow-up calls compared with standard care (discharge without follow-up).
During a clinical study conducted in several intensive care units in Denmark examined whether follow-up calls can improve patients' well-being and health, as well as the meaning of the follow-up program has on the patient's everyday life in the first year after hospitalization in the ICU.
The investigation contribute knowledge to the international research by revealing symptom burden and efficacy of a follow-up program for up to 1 year after admission to the ICU in order to be able to target rehabilitation efforts and improved the quality of life. It will be innovative to use the results from a clinical study as a foundation for a database, and the method can serve as a precedent for evidence-based introduction of guidelines, database registration and create the groundwork for future research in intensive care. This study is expected to be profitable to society by preventing frequent readmissions, reduce medication costs and fewer referrals to specialists and have a positive effect on retention to the labor market. This will provide overall better use of society's expenses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention |
| Standardized Followup program | Experimental | Other: Standardized Followup programStandardized written information, patient photos and three follow-up consultations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Non-invasive or invasive ventilation ≥ 48 hours (Non-invasive ventilation (NIV) from current guidelines).
- APACHE II score ≥ 12 ≤ 29
- Unrecognized dementia diagnosis
Key exclusion criteria (3 listed)
- Delirium at randomization (Positive CAM-ICU score)
- Participation in scientific projects which include patient interviews
- Not Speak and understand Danish
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 |
|---|---|---|
| Standardized Followup programStandardized written information, patient photos and three followup consultations. | Other | Standardized Followup program |
Primary outcome
Quality of Life
Time frame: 12 months
Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to quality of life, on the mental component of the instrument, SF-36 Intension-to-treat analysis
5 secondary outcomes
Symptom Scores
Time frame: 12 months
Baseline data
Time frame: At randomization
Symptom score
Time frame: 12 months
Depression
Time frame: 12 months
Sense of Coherence
Time frame: 12 months
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 4 Apr 2018.
- Derived from this study: PubMed 27695894Jensen JF, Egerod I, Bestle MH, Christensen DF, Elklit A, Hansen RL, Knudsen H, Grode LB, Overgaard D. A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, the RAPIT study. Intensive Care Med. 2016 Nov;42(11):1733-1743. doi: 10.1007/s00134-016-4522-1. Epub 2016 Sep 30.
- Homepage for project collaborators, this requires departmental access and passwordLink provided by the sponsor.
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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.
Janet F Jensen, PhD-student principal investigator
Hillerod Hospital, department of Anaesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Followup program in people with Intensive Care (ICU) Patients, run by Hillerod Hospital, Denmark at 1 site in Denmark.
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 3 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 4 Apr 2018. 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 Denmark. 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?
Quality of Life (time frame: 12 months). 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 NCT01721239, which also lists 1 linked publication.
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 4 Apr 2018.