Intensive Care Unit SyndromeRAPIT-IINCT03264365
The Effectiveness of a Post-ICU Recovery Program on Relatives
A study testing Intervention in people with Intensive Care Unit Syndrome and Relatives, run by Holbaek Sygehus at 1 site in Denmark.
Trial summary
Relatives of intensive care patients are at risk of developing symptoms of anxiety, depression and post-traumatic stress disorder resulting in impaired health-related quality of life (HRQOL). Recovery programs have been tested, but its effectiveness is sparse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Syndrome, Relatives
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 181 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Dec 2012to 6 Mar 2018
- 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
- 18 years of age or older
- Defined by the patients
Who cannot join
- If the patients dropped out or died during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of a Post-ICU Recovery Program on Relatives to Patients Receiving Mechanically Ventilatory Support: Data Linked to RAPIT-I Investigation
Relatives of intensive care patients are at risk of developing symptoms of anxiety, depression and post-traumatic stress disorder resulting in impaired health-related quality of life (HRQOL). Recovery programs have been tested, but its effectiveness is sparse. The hypothesis is that relatives to former intensive care patients will improve their HRQOL one year after intensive care. We want to determine whether relatives to former intensive care patient's benefits from a recovery programme with improved HRQOL, Sense Of Coherence (SOC) and symptoms of anxiety, depression and PTSD compared to standard care one year after intensive care.
Read the detailed description
Relatives of intensive care patients are affected of critical illness with symptoms of anxiety, depression and post-traumatic stress disorder resulting in impaired mental health. Recovery programs aimed at patients after a stay at the intensive care unit (ICU) have been tested and implemented, but the effectiveness is inconclusive, and on relatives sparse. The aim is to determine whether relatives to former intensive care patients benefits from a recovery programme with improved health-related quality of life (HRQOL), Sense Of Coherence (SOC), and symptoms of anxiety, depression, and PTSD compared to standard care during the first year after ICU discharge.
This was a sub-study of the "Recovery and Aftercare in Post-Intensive care Therapy patients" (RAPIT) trial; a pragmatic, non-blinded, multicentre, parallel-group, randomized controlled trial. We recruited patients and relatives concurrently during the RAPIT-trial study-period, and now we are doing analysis on relatives. We wants to include adult relatives defined by the patients from 10 Danish ICUs.
The study was powered to detect an effect size of a 5-point increase in the Medical Health Survey Short-Form 36 (SF-36) on the mental component score (MCS) in the intervention group at 12 months post-ICU. Power calculation was based on an expected distribution of MCS from a matched population with a mean of 36.7 (SD 11.7) from a similar study. With a statistical power of 80% and significance level of 0.05, we estimated that 86 relatives were needed in each group to complete follow-up.
The statistical analysis plan was based on intention-to-treat (ITT) as was per protocol (PP) analysis and investigating difference between intervention and controls. Relatives were considered to have received the intervention if the patient attended at least one of the three consultations, which accounted for the PP analysis.
- Conditions
- Intensive Care Unit Syndrome, Relatives
- Being tested
- Intervention
- Keywords
- Health-related quality of life, Anxiety, Depression, Post-traumatic stress disorder, Recovery programme, Rehabilitation, Follow-up programme, Aftercare, Randomized controlled Trial, Multicentre
- Medical subject headings
- Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Also called Standard care
Intervention (plus standard care)
- Patients photographs during the ICU-stay,
- Written information about life after ICU
- First consultation face-to-face in hospital setting at three months after ICU
- Visit ICU and photographs given
- Consultations as needed
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Relatives participated actively in the one out of three consultation conducted by trained study nurses at two months after intensive care superimposed on standard care. Receives: Behavioral: Intervention |
| Standard care | No intervention | Relatives to former ICU patients, who had received standard care (SC) completed a questionnaire package at 3 and 12 months after the patient was discharged from intensive care. After enrollment were all contract handled by primary investigator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Component Score
Health-related Quality of life using Short-form-36 questionnaire
Measured: 12 months after ICU
Secondary outcomes (11)
Mental Component Score
Health-related Quality of life using Short-form-36 questionnaire
Measured: 3 months after ICU
Physical Component Score
Health-related Quality of life using Short-form-36 questionnaire
Measured: 3 months after ICU
Physical Component Score
Health-related Quality of life using Short-form-36 questionnaire
Measured: 12 months after ICU
Anxiety
Anxiety measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 3 months after ICU
Anxiety
Anxiety measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 12 months after ICU
Depression
Depression measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 3 months after ICU
Depression
Depression measured by Hospital Anxiety and Depression Scale (HADS)
Measured: 12 months after ICU
Post-traumatic stress Disorders
Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV
Measured: 3 months after ICU
Post-traumatic stress Disorders
Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV
Measured: 12 months after ICU
Sense of coherence
Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire
Measured: 3 months after ICU
Sense of coherence
Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire
Measured: 12 months after ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start15 Dec 2012
- Primary completion31 Dec 2015
- Study completion6 Mar 2018
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 Unit SyndromeStudies 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
- Model description
- Pragmatic, non-blinded, multicenter, parallel-group randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Nordsjaellands Hospital, Herlev Hospital, Horsens Hospital, Nykøbing Falster County Hospital, Naestved Hospital, Copenhagen University Hospital, Rigshospitalet, Aabenraa Hospital, Sonderborg Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Svendborg Hospital
- Responsible party
- Principal investigator, Janet Froulund Jensen, Holbaek Sygehus
- Investigators
- RAPIT Steering Committee, Study chair, Region of Copenhagen Capital and Region of Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264365
- Sponsor's protocol ID
- 01863 HIH-2012-011
- Other IDs
- NCT-01721239
- Acronym
- RAPIT-II
- Status last verified
- Mar 2018
- First submitted
- 22 Aug 2017
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Agreement of collaboration between sites have determinated that abstracts should be evaluated by the RAPIT-steering committee prior data are shared with other researchers.
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 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Post-ICU Recovery Program on Relatives to Patients Receiving Mechanically Ventilatory Support: Data Linked to RAPIT-I Investigation
- ClinicalTrials.gov ID
- NCT03264365
- Acronym / sponsor ID
- RAPIT-II / 01863 HIH-2012-011
- Conditions
- Intensive Care Unit Syndrome, Relatives
- Keywords
- Health-related quality of life, Anxiety, Depression, Post-traumatic stress disorder, Recovery programme, Rehabilitation, Follow-up programme, Aftercare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Collaborators
- Nordsjaellands Hospital, Herlev Hospital, Horsens Hospital, Nykøbing Falster County Hospital, Naestved Hospital, Copenhagen University Hospital, Rigshospitalet, Aabenraa Hospital, Sonderborg Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Svendborg Hospital
- Study start
- 15 Dec 2012 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 6 Mar 2018 (actual)
- First posted
- 29 Aug 2017 (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.
Relatives of intensive care patients are at risk of developing symptoms of anxiety, depression and post-traumatic stress disorder resulting in impaired health-related quality of life (HRQOL). Recovery programs have been tested, but its effectiveness is sparse. The hypothesis is that relatives to former intensive care patients will improve their HRQOL one year after intensive care. We want to determine whether relatives to former intensive care patient's benefits from a recovery programme with improved HRQOL, Sense Of Coherence (SOC) and symptoms of anxiety, depression and PTSD compared to standard care one year after intensive care.
Detailed description
Relatives of intensive care patients are affected of critical illness with symptoms of anxiety, depression and post-traumatic stress disorder resulting in impaired mental health. Recovery programs aimed at patients after a stay at the intensive care unit (ICU) have been tested and implemented, but the effectiveness is inconclusive, and on relatives sparse. The aim is to determine whether relatives to former intensive care patients benefits from a recovery programme with improved health-related quality of life (HRQOL), Sense Of Coherence (SOC), and symptoms of anxiety, depression, and PTSD compared to standard care during the first year after ICU discharge.
This was a sub-study of the "Recovery and Aftercare in Post-Intensive care Therapy patients" (RAPIT) trial; a pragmatic, non-blinded, multicentre, parallel-group, randomized controlled trial. We recruited patients and relatives concurrently during the RAPIT-trial study-period, and now we are doing analysis on relatives. We wants to include adult relatives defined by the patients from 10 Danish ICUs.
The study was powered to detect an effect size of a 5-point increase in the Medical Health Survey Short-Form 36 (SF-36) on the mental component score (MCS) in the intervention group at 12 months post-ICU. Power calculation was based on an expected distribution of MCS from a matched population with a mean of 36.7 (SD 11.7) from a similar study. With a statistical power of 80% and significance level of 0.05, we estimated that 86 relatives were needed in each group to complete follow-up.
The statistical analysis plan was based on intention-to-treat (ITT) as was per protocol (PP) analysis and investigating difference between intervention and controls. Relatives were considered to have received the intervention if the patient attended at least one of the three consultations, which accounted for the PP analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pragmatic, non-blinded, multicenter, parallel-group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionRelatives participated actively in the one out of three consultation conducted by trained study nurses at two months after intensive care superimposed on standard care. |
| Standard care | No intervention | –Relatives to former ICU patients, who had received standard care (SC) completed a questionnaire package at 3 and 12 months after the patient was discharged from intensive care. After enrollment were all contract handled by primary investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Defined by the patients
Key exclusion criteria (1 listed)
- If the patients dropped out or died during the study period
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 |
|---|---|---|
| InterventionAlso: Standard careIntervention (plus standard care) * Patients photographs during the ICU-stay, * Written information about life after ICU * First consultation face-to-face in hospital setting at three months after ICU * Visit ICU and photographs given * Consultations as needed | Behavioural | Intervention |
Primary outcome
Mental Component Score
Time frame: 12 months after ICU
Health-related Quality of life using Short-form-36 questionnaire
11 secondary outcomes
Mental Component Score
Time frame: 3 months after ICU
Physical Component Score
Time frame: 3 months after ICU
Physical Component Score
Time frame: 12 months after ICU
Anxiety
Time frame: 3 months after ICU
Anxiety
Time frame: 12 months after ICU
Depression
Time frame: 3 months after ICU
Depression
Time frame: 12 months after ICU
Post-traumatic stress Disorders
Time frame: 3 months after ICU
Post-traumatic stress Disorders
Time frame: 12 months after ICU
Sense of coherence
Time frame: 3 months after ICU
Sense of coherence
Time frame: 12 months after ICU
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 7 Mar 2018.
- Background: 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.
- Individual participant dataSharing planned: Undecided. Agreement of collaboration between sites have determinated that abstracts should be evaluated by the RAPIT-steering committee prior data are shared with other researchers.
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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.
RAPIT Steering Committee study chair
Region of Copenhagen Capital and Region of Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Intensive Care Unit Syndrome and Relatives, run by Holbaek Sygehus 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 2 inclusion and 1 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 7 Mar 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?
Mental Component Score (time frame: 12 months after ICU). 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 NCT03264365, 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 7 Mar 2018.