Recovery and Aftercare in Post Intensive Care Therapy Patients - RAPIT Study

NCT01721239 | Completed DMC

• 1 other identifier: HIH-01863-2012-011
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

ICU; Follow-up consultations; Quality of life; Sense Of Coherence; RCT multicenter study

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (5)

• Symptom Scores

  12 months

• Baseline data

  At randomization

• Symptom score

  12 months

• Depression

  12 months

• Sense of Coherence

  12 months

Other Outcomes (4)

• Post traumatic stress

  12 months

• Anxiety

  12months

• Register data

  12 months

Study Arms (2)

Control group

NO INTERVENTION

No intervention

Standardized Followup program

EXPERIMENTAL

Standardized written information, patient photos and three follow-up consultations.

Other: Standardized Followup program

Interventions

Standardized Followup program OTHER

Standardized written information, patient photos and three followup consultations.

Standardized Followup program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Delirium at randomization (Positive CAM-ICU score)
• Participation in scientific projects which include patient interviews
• Not Speak and understand Danish

Sponsors & Collaborators

• Hillerod Hospital, Denmark: lead
• Herlev Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Nykøbing Falster County Hospital: collaborator
• Odense University Hospital: collaborator
• Sonderborg Hospital: collaborator
• Region of Southern Denmark: collaborator
• Regionshospitalet Horsens: collaborator
• Naestved Hospital: collaborator

Study Sites (1)

Department of Anaestesiology

Hillerød, 3400, Denmark

Location

Related Publications (1)

• 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.

  PMID: 27695894 DERIVED

Related Links

• Homepage for project collaborators, this requires departmental access and password

Study Officials

• Janet F Jensen, PhD-student

  Hillerod Hospital, department of Anaesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD, MSc Health Science, RN.

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: November 5, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 4, 2018

Record last verified: 2018-04

Locations

DK (1)