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.: PACTR202205481965514 Date of Approval: 30/05/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Football nurse: A community based, task sharing approach to improve best sports and exercise medicine practice in women’s football in low income and middle income settings.
Official scientific title Football nurse: A community based, task sharing approach to improve best sports and exercise medicine practice in women’s football in Malawi.
Brief summary describing the background and objectives of the trial Football (soccer) is a very popular sport in Africa and player numbers continue to rise at all levels of the sport. This increase in participation is also directly associated with an increase in football related injuries. While participation in football and injuries arising thereof are increasing, there are not enough sports and exercise medicine (SEM)personnel (physiotherapists and doctors) to attend to these football players, which results in an enormous treatment gap in sports injuries and compromises their safe participation in football. This lack of medical care is even more pronounced in female teams: females tend to bear the brunt in any environment of scarcity. Africa may not currently have enough medical doctors and/or physiotherapists (PT); however, it has relatively higher numbers of other healthcare workers; namely, nurses. While access to a medical doctor or PT may be aspirational for most citizens of Africa, nurses provide healthcare from grassroots/community level and sometimes healthcare facilities are exclusively staffed by nurses. Perhaps, instead of having an SEM strategy that is heavily reliant on doctors and PTs as in high income settings, we ought to adapt current global standards to fit the human resources profile of low income settings such as in Africa and include the largest group of healthcare providers by numbers, nurses. Therefore, the aim of this pilot project is to develop a community and strength based, task sharing approach (Football Nurse) to actively recruit and train nurses as pitch side responders in grassroots women’s football.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Football Nurse Project
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 04/06/2022
Actual trial start date
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 720
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL https://www.footballnurse.com/
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 Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Football nurse Data collection by the nurses on injuries to be done during the team's training which is at least three times per week. Data will be collected throughout the women football season from June to December, 2022. Prior to the beginning of the season, a cohort of 12 nurses will receive seven day training in basic football medicine using the adapted versions of the latest FIFA Football Medicine training manuals. The training of nurses will cover common football injuries and medical emergencies with emphasis on recognition, assessment, diagnosis, and immediate care of on field injuries as well as specific considerations for the female football player. The training will also cover the referral pathways of serious cases such as head/ spinal injuries, and fractures. After training, at the beginning of the season, the nurses will be attached to 12 female football teams during one competitive season. 360
Control Group No Football nurse At least three times per week. For the whole period of the women's football season from June to December, 2022 Teams in the control group will not have a nurse. The group will continue their current sports and exercise medicine practice as is. 360 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women’s football clubs in the Women’s League in Malawi registered with the Football Association of Malawi (FAM). Nurses registered with the Nurses and Midwives Council of Malawi with at least 3 years post graduate experience. Physiotherapists with a recognised university qualification in physiotherapy (HPT), registered with the Medical council of Malawi and at least 3 years post graduate practice experience. Medical doctors with a recognised university qualification (MBChB) registered with the Medical and Dental Association of Malawi and at least 3 years post graduate practice experience. Willingness to and actual completion of the online FIFA Medical Diploma over a maximum period of 3-months prior to the commencement of the project. Women’s football clubs in the Women’s League in Malawi that already have medical personnel attached to their team. For potential supervisors, less than 3 years post qualification experience; incomplete FIFA Medical Diploma. For potential Football Nurses, less than 3 years of post-qualification experience. For potential Football Nurses and supervisors, current attachment to a Women’s Football club in Malawi’s Women’s League. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 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 11/04/2022 College of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mahatma Gandhi road Blantyre NA Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Low cost, sustainable and context relevant solution to manage the treatment gap of football injuries/illnesses in underserved communities developed. At the end of the research project
Secondary Outcome A flagship model which can inform implementation of similar task sharing approaches to sports and exercise medicine practice in other low and middle income countries in Africa and globally developed. At the end of the research project
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kamuzu University of Health Sciences Mahatma Gandhi road Blantyre NA Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
FIFA NA Zurich Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor FIFA NA Zuric Switzerland Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Rorschach Innovation Services 3 Bowden road CapeTown South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Enock Chisati echisati@kuhes.ac.mw +265997008034 Mahatma Gandhi road
City Postal code Country Position/Affiliation
Blantyre Malawi Senior Lecturer at Kamuzu University of Health Sciences
Role Name Email Phone Street address
Scientific Enquiries Nonhlanhla Mkumbuzi nsmkumbuzi@gmail.com +265793916969 NA
City Postal code Country Position/Affiliation
Johannesburg South Africa Researcher
Role Name Email Phone Street address
Public Enquiries Esther Jiya estherjiya96@gmail.com +265994276808 Mahatma Gandhi road
City Postal code Country Position/Affiliation
Blantyre Malawi Research Assistant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified IPD will be available upon request from COMREC, an Institution Review Board that approved the study. Clinical Study Report,Informed Consent Form,Study Protocol Data will be shared 5 months after completion of the trial IPD can be accessed by sending a request to COMREC through email at comrec@medcol.mw or through phone on +26588118993. Only deidentified IPD can be shared. Those requesting data for further analyses should clearly indicate in their request. Approval for data requests for further analyses will be done on case by case basis. A decision to by COMREC to share data will be done in collaboration with the Principal Investigators with consent from the funders. All requests will be evaluated based on purpose, quality and qualification.
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