REhabilitation After Critical Illness Assisted Discharge Pack (RECAP)

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT02415634
• Date of registration: 06/04/2015
• Prospective Registration: No
• Primary sponsor: Maire Gilmartin
• Public title: REhabilitation After Critical Illness Assisted Discharge Pack (RECAP) RECAP
• Scientific title: Investigation of Physiotherapy Led ICU Discharge Facilitation Using the REhabilitation After Critical Illness Assisted Discharge Pack (RECAP) Model; a Pilot Randomized Controlled Trial.
• Date of first enrolment: November 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02415634
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Ireland

Contacts

• Name: Martina Fitzpatrick
• Affiliation: Physiotherapy Manager (Temporary), St. Vincent's University Hospital, Elm Park, Dublin 4, Ireland

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients admitted to ICU >4 days

- Indication for physiotherapy referral in ICU

- Indication for follow up physiotherapy on discharge from the ICU

- Age>18 years

- RASS score 0 at time of consent

Exclusion Criteria:

- ICU length of stay >14 days

- Patients with a multi-disciplinary team based work-up in advance of a planned ICU
admission (e.g. Liver transplant)

- Pregnant mothers

- Palliation

- Expected discharge to another hospital

- Unable to understand English

- Patients who have direct access to condition specific MDT follow up (e.g. Stroke,
Neurology)

- Psychiatric Disease

- Unstable Cardiac Disease

- Where physiotherapy treatment is limited or maximal functional capacity is capped for
duration of study (e.g. Non Weight Bearing status due to orthopaedic limitation x 12
weeks.

- Patients who are unable to give consent



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Critical Illness

Intervention(s)

Other: Control

Other: RECAP

Primary Outcome(s)

Change from baseline State Anxiety inventory (SAI), a subscale of State-Trait Anxiety Inventory [Time Frame: Assessed at week one to detect change from baseline in SAI score as a result of intervention]

Change from baseline in Functional Independence Measure (FIM) [Time Frame: Assessed at week three to detect change from baseline FIM score as a result of intervention]

Change from baseline State Anxiety inventory (SAI), a subscale of State-Trait Anxiety Inventory [Time Frame: Assessed at week three to detect change from baseline in SAI score as a result of intervention]

Secondary Outcome(s)

Chelsea Critical Care Physical Assessment Tool (CPAx) [Time Frame: Assessed at day one]

Patient Rehabilitation Satisfaction Questionnaire [Time Frame: 3 weeks post intensive care discharge]

Secondary ID(s)

GilmartinSept2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

St Vincent's University Hospital, Ireland

University of Ulster