The Effectiveness of a Post-ICU Recovery Program on Relatives (RAPIT-II)

March 6, 2018 updated by: Janet Froulund Jensen, Holbaek Sygehus

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
181

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Sjælland
      • Holbæk, Sjælland, Denmark, 4300
        • Holbæk Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Defined by the patients

Exclusion Criteria:

  • If the patients dropped out or died during the study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
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.
Behavioral: Intervention

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
Other Names:
  • Standard care
No Intervention: Standard care
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mental Component Score
Time Frame: 12 months after ICU
Health-related Quality of life using Short-form-36 questionnaire
12 months after ICU

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mental Component Score
Time Frame: 3 months after ICU
Health-related Quality of life using Short-form-36 questionnaire
3 months after ICU
Physical Component Score
Time Frame: 3 months after ICU
Health-related Quality of life using Short-form-36 questionnaire
3 months after ICU
Physical Component Score
Time Frame: 12 months after ICU
Health-related Quality of life using Short-form-36 questionnaire
12 months after ICU
Anxiety
Time Frame: 3 months after ICU
Anxiety measured by Hospital Anxiety and Depression Scale (HADS)
3 months after ICU
Anxiety
Time Frame: 12 months after ICU
Anxiety measured by Hospital Anxiety and Depression Scale (HADS)
12 months after ICU
Depression
Time Frame: 3 months after ICU
Depression measured by Hospital Anxiety and Depression Scale (HADS)
3 months after ICU
Depression
Time Frame: 12 months after ICU
Depression measured by Hospital Anxiety and Depression Scale (HADS)
12 months after ICU
Post-traumatic stress Disorders
Time Frame: 3 months after ICU
Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV
3 months after ICU
Post-traumatic stress Disorders
Time Frame: 12 months after ICU
Post-traumatic stress measured by the Harvard trauma Quesionnaire, ver. IV
12 months after ICU
Sense of coherence
Time Frame: 3 months after ICU
Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire
3 months after ICU
Sense of coherence
Time Frame: 12 months after ICU
Sense Of Coherence measured by the 13-item Orientation to Life questionnaire Questionnaire
12 months after ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Holbaek Sygehus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rigshospitalet, Denmark
Herlev Hospital
Svendborg Hospital
Naestved Hospital
Nykøbing Falster County Hospital
Sonderborg Hospital
Hospital of South West Jutland
Horsens Hospital
Nordsjaellands Hospital
Aabenraa Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: RAPIT Steering Committee, Region of Copenhagen Capital and Region of Zealand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 01863 HIH-2012-011
  • NCT-01721239 (Other Identifier: Registry Identifier of RAPIT-I on ClinicalTrials.gov)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Agreement of collaboration between sites have determinated that abstracts should be evaluated by the RAPIT-steering committee prior data are shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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