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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02582619
Other study ID # BE499/14
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2015
Est. completion date August 2021

Study information

Verified date October 2021
Source University of KwaZulu
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Spinal cord injury often results in complete or partial loss of functioning of the upper and or lower limbs, leading to the affected individual experiencing difficulties in performing activities of daily living. This in turn results in reduced participation in social, religious, recreational and economic activities (employment). Globally, there is a low employment rate (11-67%) amongst PLWSCI. In South Africa, according to Statistics South Africa, the unemployment rate of people with disabilities is estimated to be 25.2%. However, there is no information available on employment amongst PLWSCI in South Africa. Furthermore, there is insufficient knowledge related to SCI in South Africa to enable a model to be developed and implemented. Data on the current SCI rehabilitation practices (with specific reference to vocational rehabilitation); employment status and factors (both personal and environmental); barriers and facilitators of employment amongst PLWSCI is limited. This information is needed to develop a return to work model for individuals with SCI in South Africa. In South Africa, a legal framework exists that promotes the employment as well as assistance of people with disabilities in the workplace, such as: the Constitution of Republic of South Africa, 1996; the Employment Equity Act (EEA), 1998; the Promotion of Equality and Prevention of Unfair Discrimination Act (PEPUDA), 2000; Labour Relations Act (LRA), 1995; Skills Development Act (SDA), 1998; Public Service Act (PSA), 1994; Basic Conditions of Employment Act (BCEA), 1997 and the Integrated National Disability Strategy (2000). However, rehabilitation interventions provided in rehabilitation institutions are mainly medical, with limited attempts to prepare those with SCI to return to gainful employment. There is therefore a need for a well-coordinated, multi-sectorial, multi-disciplinary and multi-factorial rehabilitation intervention that will promote the employment of PLWSCI in South Africa.


Description:

This is a cross-sectional study in which mixed methods will be used in various phases of the study. Mixed methods involve the collection and analysis of both quantitative and qualitative data in a single study. Data are collected concurrently or sequentially and integrated at one or more stages during the research process. This study will be divided into 3 phases with stages to answer the objectives. Phase one of this study will attempt to answer objectives 1-3 of the study. Stage 1 will include a systematic review of literature to identify the most effective vocational rehabilitation interventions amongst PLWSCI. Stage 2 will determine rehabilitation services rendered to individual who sustain SCI in South Africa with an intention of identifying gaps in vocational rehabilitation practices by retrospectively analysing medical files. This phase will be concluded by a focus group to further explore current vocational rehabilitation practices rendered to PLWSCI (Stage3). Phase two will answer objectives 4-5. Stage 1 of this phase will determine the employment status as well as factors that influence employment amongst PLWSCI. Stage 2 will determine the barriers and facilitators of employment amongst PLWSCI. Results obtained from phase 1 to 2, will be utilised to by the researcher to develop the proposed model. The final phase will aim to develop, validate and refine the model. Stage 1 of this phase will include the researcher using the information gained in previous phases to develop the proposed model. The second stage will include a focus group to validate the content of the proposed model. The last stage will included obtaining consensus amongst the stakeholders regarding the structure and the content of the proposed model and subsequently refine it.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date August 2021
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years to 65 Years
Eligibility Phase One: Inclusion Criteria: • Rehabilitation professionals who are directly involved in the management of individuals who sustain SCI and have more than 1 year of working experience post community service. Exclusion Criteria: • Rehabilitation professionals who are not directly involved in the management of individuals who sustain SCI and have less than 1 year working experience post community service. Phase Two : Inclusion Criteria: • Person who sustained injury to the spine, resulting in permanent neurological damage (complete or incomplete) and must reside in a rural, peri-urban and urban. Exclusion Criteria • People living with spinal cord injuries who cannot verbally communicate Phase Three Inclusion Criteria - PLWSCI Injury to who resides in a rural, peri-urban and urban. - Rehabilitation professionals who are directly involved in the management of individuals who sustain SCI and have more than 2 years of experience post community service. - An individual who is full time employed in a supervisory and managerial capacity in both private and public sector, currently have subordinates who are PLWSCI. - A representative from the Disability Section of an insurance company that is the member of the LOA. Exclusion Criteria - PLWSCI who cannot verbally communicate. - Rehabilitation professionals who are not directly involved in the management of individuals who sustain SCI and have less than two years of experience post community service. - An individual who is employed on a part-time basis and not in supervisory or managerial positions and have no subordinates who are PLWSCI.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Focus groups, semistructured interviews and Delphi rounds


Locations

Country Name City State
South Africa King Dinizulu Hospital Durban KwaZulu-Natal
South Africa Phoenix Spinal Rehabilitation Centre Durban KwaZulu-Natal
South Africa Greys Hospital Pietermaritzburg KwaZulu-Natal

Sponsors (1)

Lead Sponsor Collaborator
University of KwaZulu

Country where clinical trial is conducted

South Africa, 

References & Publications (71)

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* Note: There are 71 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary A multidisciplinary model to guide employment amongst people living with spinal cord injuries The final model will be developed using all the information gained from the Phase one and two of the study. A validation process will be done through the delphi rounds. 18 months
Secondary Systematic Review of effective Vocational Rehabilitation interventions amongst People Living With Spinal Cord Injuries The review study will follow the Chocrane A journal article will be published in a peer reviewed journal. Five Months
Secondary Rehabilitation Practices that promote employability of People Living with Spinal Cord Injuries Stage 2 and Stage Three of Phase one will develop a matrix or guideline of vocational rehabilitation interventions throughout the phases of rehabilitation. Three months
Secondary Employment and Factors that affect employment amongst People living with Spinal Cord Injuries Employment rates and nature of employment will be quantified using the International Labour Organisation definition of employment. The Factors affecting employment will also be quantified using the modified Life Situation Questionnaire. Five months
Secondary Barriers and Facilitators of employment amongst people living with spinal cord injuries. Interviews and focus groups will be conducted to determine the barriers and facilitators of employment amongst PLWSCI. 8 months
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