Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202305860988637 Date of Approval: 22/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Functional outcomes of medical and trauma patients in a critical care unit using the Chelsea Critical Care Physical Assessment tool
Official scientific title Functional outcomes of medical and trauma patients in a critical care unit using the Chelsea Critical Care Physical Assessment tool
Brief summary describing the background and objectives of the trial Background: The use of outcome measures by healthcare providers in daily clinical practise assists to better follow a patient’s condition progress in order to provide effective quality of care. The role of physiotherapists in the intensive care unit promotes lung function and facilitates early patient mobilization to prevent complications. The implementation of the Chelsea Critical Care Physical Assessment (CPAx) tool in daily use will benefit both patients and clinicians as patient specific rehabilitation will be encouraged. Aim: To determine the functional outcomes using the Chelsea Critical Care Physical Assessment tool in critically ill patients admitted in the trauma and medical critical care units.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 16/01/2023
Actual trial start date 16/05/2023
Anticipated date of last follow up 30/06/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 64
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Chelsea Critical Care Physical Assessment tool 3 times a week From admission to the medical intensive care unit and high care until discharge from the critical care setting Assessment of physical functions 32
Control Group Chelsea Critical Care Physical Assessment tool 3 times a week From admission to discharge from the trauma ICU and high care units Assessing the physical functions 32 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients: • Patients with a negative covid PCR result on ICU admission. • Patients who are haemodynamically stable according to the normal values to measure the heart rate (from 60 bpm to 100 bpm) and blood pressure of a systolic pressure between 90mmHg and 120mmHg and diastolic pressure between 60mmHg and 80mmHg. Patients should not be on any vasopressors. Physiotherapists: • Qualified physiotherapists working in the medical and trauma ICU and HC units • Community service physiotherapists • Physiotherapists who sign consent forms Patients: • Patients who have peripheral neurological fallouts due to trauma or surgery. • Spinal cord injury patients as diagnosed by the doctor Physiotherapists: • Physiotherapy assistants • Physiotherapy students • Physiotherapists who refuse to participate 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/07/2022 Faculty of Health Sciences Research Ethics Committee of the University of Pretoria
Ethics Committee Address
Street address City Postal code Country
Room 4-60, Level 4, Tshwelopele Building, University of Pretoria, Gezina Pretoria 0031 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Functional outcomes of the patient in the critical care including the respiratory functions, cough effectiveness, mobility in and out of the bed, balance in sitting and in standing, taking steps and hand grip strength. Every second day while in the critical care setting
Secondary Outcome Physiotherapists perceptions of using the Chelsea Critical care Physical Assessment tool At the end of data collection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Steve Biko Academic Hospital Cnr Steve Biko and Malan Street, Capital Park Pretoria 0002 South Africa
Kalafong Hospital 10 Kalafong Rd, Atteridgeville Pretoria 0008 South Africa
Dr George Mukhari Hospital 3111 Setlogelo Drive, Ga-Rankuwa Unit 2 Pretoria 0208 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Miss LC Tjale 810 Breed Street, Montana Pretoria 0182 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor MIss LC Tjale 810 Breed Street, Montana Pretoria 0182 South Africa Self sponsored
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lebogang Tjale chresia22@gmail.com +27820596079 810 Breed Street, Montana
City Postal code Country Position/Affiliation
Pretoria 0182 South Africa Principal Investigator
Role Name Email Phone Street address
Public Enquiries Lebogang Tjale chresia22@gmail.com +27820596079 810 Breed Street, Montana
City Postal code Country Position/Affiliation
Pretoria 0182 South Africa Principal Investigator
Role Name Email Phone Street address
Scientific Enquiries Lebogang Tjale chresia22@gmail.com +27820596079 810 Breed Street, Montana
City Postal code Country Position/Affiliation
Pretoria 0182 South Africa Principal Investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected will be made available after de-identification, study protocol, Informed consent, Statistical analysis plan, clinical study report, analytical data immediately after publication and is open to anyone who wishes to access data. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately after publication Open to anyone who wishes to access data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information