Recovery of Post Intensive Care Patients - RAPIT Study

This study is currently recruiting participants.
Verified February 2014 by Hillerod Hospital, Denmark
Sponsor:
Collaborators:
Herlev Hospital
Rigshospitalet, Denmark
Nykøbing Falster County Hospital
Odense University Hospital
Sonderborg Hospital
Region Southern Denmark
Regionshospitalet Horsens
Naestved Hospital
Information provided by (Responsible Party):
Janet Froulund Jensen, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01721239
First received: October 31, 2012
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Intensive Care (ICU) Patients
Other: Standardized Followup program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Recovery of Post Intensive Care Patients - The RAPIT Study. A Randomized Controlled Multicenter Intervention Study.

Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Symptom Scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Changes in score regarding symptoms scores in control and intervention groups.

  • Baseline data [ Time Frame: At randomization ] [ Designated as safety issue: No ]
    baseline data concerning patient's demographic and clinical data

  • Symptom score [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to symptom scores.

  • Depression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Changes in score regarding depression in control and intervention groups

  • Sense of Coherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Changes over time in patients in the intervention and control group measured with instruments used and register data, corresponding to sense of coherence


Other Outcome Measures:
  • Post traumatic stress [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Changes in score regarding post traumatic stress in control and intervention groups.

  • Anxiety [ Time Frame: 12months ] [ Designated as safety issue: No ]
    Changes in score regarding anxiety in control and intervention groups.

  • Register data [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Changes in score regarding register data concerning:

    1. Mortality
    2. The number of readmissions
    3. Outpatient visits
    4. Checks at GP
    5. Home care
    6. Medication use
    7. Referrals to specialists, physical and occupational therapy, including
    8. Return to work in control and intervention groups

  • Non-respondent [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    A non-respondent analysis. The number of participants who dropout of the study will be separated, analyzed in control and intervention groups regarding demographic and clinical data collected during ICU stay. Investigate if there is difference in dropout in the interventiongroup versus the controlgruop.

    Intension-to-treat analysis of participants recieving the first consultation.



Estimated Enrollment: 340
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
No intervention
Experimental: Standardized Followup program
Standardized written information, patient photos and three follow-up consultations.
Other: Standardized Followup program
Standardized written information, patient photos and three followup consultations.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Delirium at randomization (Positive CAM-ICU score)
  • Participation in scientific projects which include patient interviews
  • Not Speak and understand Danish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721239

Contacts
Contact: Janet F. Jensen, PhD-student +45-48296089 ext +45-26813406 Janet.Froulund.Jensen@regionh.dk
Contact: Ingrid Egerod, Professor +45 3545 2896 Ingrid.Egerod@regionh.dk

Locations
Denmark
Department of Anaestesiology Recruiting
Hillerod, Denmark, 3400
Contact: Janet F Jensen, PhD-student    +45-2681 3406    janet.froulund.jensen@regionh.dk   
Contact: Ingrid Egerod, Professor    +45-3545 2896    ingrid.egerod@regionh.dk   
Principal Investigator: Janet F Jensen, PhD-student         
Sponsors and Collaborators
Hillerod Hospital, Denmark
Herlev Hospital
Rigshospitalet, Denmark
Nykøbing Falster County Hospital
Odense University Hospital
Sonderborg Hospital
Region Southern Denmark
Regionshospitalet Horsens
Naestved Hospital
Investigators
Principal Investigator: Janet F Jensen, PhD-student Hillerod Hospital, department of Anaesthesiology
  More Information

Additional Information:
No publications provided

Responsible Party: Janet Froulund Jensen, MSc Health Science, RN., Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01721239     History of Changes
Other Study ID Numbers: HIH-01863-2012-011
Study First Received: October 31, 2012
Last Updated: February 13, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by Hillerod Hospital, Denmark:
ICU
Follow-up consultations
Quality of life
Sense Of Coherence
RCT multicenter study

ClinicalTrials.gov processed this record on April 17, 2014