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.: PACTR201903791483839 Date of Approval: 08/03/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effectiveness of the Model of Occupational Self Efficacy in improving the cognitive functioning of individuals with traumatic brain injury: A randomised control study.
Official scientific title The effectiveness of the Model of Occupational Self Efficacy in improving the cognitive functioning of individuals with traumatic brain injury: A randomised control study.
Brief summary describing the background and objectives of the trial The return to work rate of individuals diagnosed with a traumatic brain injury (TBI) is controversial. In South Africa there is a general void in the literature that focuses on how the cognitive and work related skills of individuals who was diagnosed with a mild to moderate TBI improves after they have participated in a randomised control trial using the Model of Occupational Self Efficacy as a rehabilitation framework. This study aims to determine whether the Model of Occupational Self Efficacy is an effective model in improving the quality of life, cognitive functioning and the rate of return to work for individuals with mild to moderate brain injury. The study will utilise a randomised control research design whereby 40 participants will be randomly allocated to a control group and 40 participants to an experimental group. The TBI participants will be selected from the statistical records from the occupational therapy department at Groote Schuur Hospital. The participants will be provided with self-administered questionnaires (i.e. Montreal Cognitive Assessment, Behavioural Assessment of Dysexecutive Functioning, WASP and Rivermead Questionnaire) to complete at the start of the programme and then at the end of the programme. The data will be analysed by means of descriptive and inferential statistics. The study will only be conducted once permission is obtained from the study participants, UWC research committee and from the Research Ethics Committee at Groote Schuur Hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) not applicable
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/03/2019
Actual trial start date
Anticipated date of last follow up 19/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Active, not 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
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard Therapy 3-4 times per week 6-8 weeks Standard cognitive intervention program for patient with traumatic brain injury 40 Active-Treatment of Control Group
Experimental Group MOOSE 3-4 times per week 6-8 weeks New cognitive rehabilitation as specified by the model of occupational self efficacy 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The participants should be diagnosed with either a mild to moderate brain injury according to the Glasgow Coma Scale and they must be 4- 6 months post TBI. The participants will be male or female, between the ages of 18-45 years and be able to communicate effectively in English or Afrikaans. The participants should be employed for at least 3 months before having sustained a TBI. The participants must have either completed in-patient and or out-patient rehabilitation such as physiotherapy, occupational therapy and or speech therapy at GSH (they are currently in the hospital system). Participants who suffered severe TBI’s as literature indicated that it is unlikely that these participants would be able to re-enter the open labour market. Participants who are displaying active acute psychiatric symptoms as well as those with co-morbidities that are not well controlled will be excluded from this study. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 25/09/2018 Biomedical Science Research Ethics Committee of the University of the Western Cape
Ethics Committee Address
Street address City Postal code Country
Private Bag X17, Bellville 7535 South Africa Cape Town 8000 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • To determine the association between descriptive variables such as age, education, work experience and the return to work rate of individuals who participated in the MOOSE programme in comparison to another participant group that received the usual vocational rehabilitation treatment. middle and end
Secondary Outcome To determine whether the return to work rate of TBI survivors improves after completing the MOOSE programme in comparison to another participant group that received the usual vocational rehabilitation treatment. middle and end
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Hospital Groote Schuur Hospital, Main Road, Observatory Cape Town 8000 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Fund Private Bag X17, Bellville 7535 South Africa Cape Town 8000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof Shaheed Soeker Private Bag X17, Bellville 7535 South Africa Cape Town 8000 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Shaheed Soeker Private Bag X17, Bellville 7535 South Africa Cape Town 8000 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tarryn Lee Dyers tarrynlee21@gmail.com 0727512878 119 Horak Street, Peerless Park East, Kraaifontein
City Postal code Country Position/Affiliation
Cape Town 7570 South Africa Occupational therapist
Role Name Email Phone Street address
Public Enquiries Shaheed Soeker msoeker@uwc.ac.za 0219599339 Private Bag X17, Bellville 7535 South Africa
City Postal code Country Position/Affiliation
Cape Town 7535 South Africa Supervisor
Role Name Email Phone Street address
Scientific Enquiries Shaheed Soeker msoeker@uwc.ac.za 0219599339 Private Bag X17, Bellville 7535 South Africa
City Postal code Country Position/Affiliation
Cape Town 7535 South Africa Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be available after the study however the participants anonymity will kept confidential Informed Consent Form within 12 months of completion of the study It will be available in journals for the profession
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