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.: PACTR201903469986111 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 as an intervention for individuals with Traumatic Brain injury: A Randomized Control Trial
Official scientific title The effectiveness of the Model of Occupational Self Efficacy as an intervention for individuals with Traumatic Brain injury: A Randomized Control Trial
Brief summary describing the background and objectives of the trial The functional ability of individuals diagnosed with a traumatic brain injury (TBI) to return to work is often limited after his or her injury. In South Africa there is a general void in the literature that focuses on how an individual with TBI’s symptoms of depression, anxiety, self efficacy, quality of life and work related skills 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 if the psychological symptoms, quality of life, self-efficacy and work skills of individuals with mild to moderate brain injury improves after participating in a vocational rehabilitation programme based on the stages of the MOOSE. 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. The Beck Depression Inventory, Beck Anxiety Inventory, the Work Rehabilitation Questionnaire, Generalised Self Efficacy Scale and World Health Organisation Quality of Life 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 relevant health authority (Provincial Administration Western Cape).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 20/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Not yet 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 to 4 times a week 6-8 weeks cognitive intervention strategies utilized for patients post TBI 45 Active-Treatment of Control Group
Experimental Group MoOSE 3 to 4 times a week 6-8 weeks the use of the Model of Occupational Self-Efficacy when providing intervention to patients that have sustained TBI 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
TBI according to the Glasgow coma scale. Participant between the ages of 18-45 Able to communicate in English and or Afrikaans 4- 6 months post TBI. Employed for at least 3 months before having sustained a TBI Must have had completed in-patient rehabilitation such as physiotherapy, occupational therapy and or speech therapy Severe TBI’s Participants who are displaying active acute psychiatric symptoms Co-morbidities that are not well controlled will be excluded from this study Adolescent: 13 Year-18 Year,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
Robert Sobukwe Drive, Bellville 7535 South Africa Belville 7535 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine whether the psychological symptoms, quality of life, self-efficacy and work skills of individuals with mild to moderate brain injury improves after participating in a vocational rehabilitation programme based on the stages of the MOOSE when compared to another participant group that is receiving the usual vocational rehabilitation treatment. at the start and end of the intervention program
Secondary Outcome To determine whether an individual with TBI’s self-efficacy improves after they have participated in the MOOSE in comparison to another participant group that received the usual vocational rehabilitation treatment at the start and end of the treatment program
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Hospital 1 Main Road Observatory 7925 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Research Fund Robert Sobukwe Drive Bellville 7535 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shaheed Soeker Robert Sobukwe Drive Bellville 7535 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof Shaheed Soeker Robert Sobukwe Drive Bellville 7535 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ayesha Noordien ayeshanoordien@yahoo.co.uk 0214046521 10 Devon road
City Postal code Country Position/Affiliation
lansdowne 7780 South Africa Chief Occupational Therapist
Role Name Email Phone Street address
Public Enquiries shaheed soeker msoeker@uwc.ac.za +27219599339 Private Bag X17
City Postal code Country Position/Affiliation
Bellville 7535 South Africa supervisor
Role Name Email Phone Street address
Scientific Enquiries shaheed soeker msoeker@uwc.ac.za +27219599339 Private Bag X17
City Postal code Country Position/Affiliation
Bellville 7535 South Africa supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data will made available after the study, however participant anonymity will be maintained as indicated in the research proposal regarding confidentiality and ethical considerations Informed Consent Form this will be made available within 6-12 months from conclusion of study 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