NCT04186611

Brief Summary

The objective of the study is to assess the feasibility of early daily occupational therapy intervention within an interdisciplinary team in an intensive care unit of a Swiss university hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

November 8, 2019

Last Update Submit

February 23, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Early daily occupational therapy intervention feasability (case report form with questions to ask)

    Assess the feasibility of providing early daily occupational therapy interventions in the Adult Intensive Medicine Service of the Centre Hospitalier Universitaire Vaudois within the current interdisciplinary team. Every day, the occupational therapist complete a case report form which say if the intervention can be realise or not in order to find the feasability of a daily early occupationnal therapy intervention. The feasability is mesure every day for each participant until they leave the intensive care unit. the feasibility assessment contains several elements, including the possibility or not of carrying out the intervention, but also the safety aspect with the collection of possible adverse events.

    Up to intensive care unit discharge, estimated as an average of 6 days

Secondary Outcomes (1)

  • Daily occupational therapy intervention description by completion of case report form

    Up to intensive care unit discharge, estimated as an average of 6 days

Study Arms (1)

Early daily occupational therapy intervention

EXPERIMENTAL

A daily occupational therapy intervention is performed with the patients included. The intervention will consist of assessment as well as early positioning and/or rehabilitation in activities of daily living.

Other: early occupational therapy

Interventions

The intervention will be the one usually carried out but earlier and on a daily basis. It will consist of the initial assessment and then positioning and/or carrying out activities of daily living. The daily duration of the intervention will be about 45 minutes to 1 hour. The overall duration of the intervention will be determined according to the objectives and will be at most equal to the time of stay in the intensive care unit.

Early daily occupational therapy intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years old.
  • Hospitalized at SMIA for at least 48 hours.
  • Stable patient: hemodynamically stabilized patient (norepinephrine dose \< 15 mcg/min iv), respiratory (P/F ratio \> 150) and neurological (Glasgow Coma Scale \> 8).

You may not qualify if:

  • contraindication to occupational therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2019

First Posted

December 5, 2019

Study Start

October 14, 2019

Primary Completion

December 6, 2019

Study Completion

December 6, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations