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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01721239
Acronym
RAPIT
Enrollment
340
Registered
2012-11-05
Start date
2012-12-01
Completion date
2016-10-31
Last updated
2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care (ICU) Patients

Keywords

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

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.

Interventions

OTHERStandardized Followup program

Standardized written information, patient photos and three followup consultations.

Sponsors

Herlev Hospital
CollaboratorOTHER
Rigshospitalet, Denmark
CollaboratorOTHER
Nykøbing Falster County Hospital
CollaboratorOTHER
Odense University Hospital
CollaboratorOTHER
Sonderborg Hospital
CollaboratorOTHER_GOV
Region of Southern Denmark
CollaboratorOTHER
Regionshospitalet Horsens
CollaboratorOTHER
Naestved Hospital
CollaboratorOTHER
Hillerod Hospital, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of Life12 monthsChanges 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

MeasureTime frameDescription
Baseline dataAt randomizationbaseline data concerning patient's demographic and clinical data
Symptom Scores12 monthsChanges in score regarding symptoms scores in control and intervention groups.
Symptom score12 monthsChanges over time in patients in the intervention and control group measured with instruments used and register data, corresponding to symptom scores.
Depression12 monthsChanges in score regarding depression in control and intervention groups
Sense of Coherence12 monthsChanges over time in patients in the intervention and control group measured with instruments used and register data, corresponding to sense of coherence

Other

MeasureTime frameDescription
Register data12 monthsChanges in score regarding register data concerning: 1. Mortality 2. The number of readmissions 3. Outpatient visits 4. Referrals to specialists, physical and occupational therapy, including in control and intervention groups
Non-respondent12 monthsA 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.
Anxiety12monthsChanges in score regarding anxiety in control and intervention groups.
Post traumatic stress12 monthsChanges in score regarding post traumatic stress in control and intervention groups.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026