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.: PACTR201705002285194 Date of Approval: 11/05/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Feasibility of training Community Health Workers in Ear and Hearing Care in Malawi: A cluster randomised controlled trial
Official scientific title Feasibility of training Community Health Workers in Ear and Hearing Care in Malawi: A cluster randomised controlled trial
Brief summary describing the background and objectives of the trial Hearing loss is the most common sensory disability and its prevalence is increasing globally with population ageing.1According to the World Health Organisation (WHO), an estimated 360 million people, or 5.3% of the world¿s population, are living with disabling hearing impairment. Data for Sub-Saharan Africa are sparse, but the prevalence of hearing impairment may be even higher in this region. The leading causes of hearing impairment in Sub-Saharan Africa are believed to be middle ear disease and impacted wax, and are therefore easily amenable to treatment and prevention. The aim of this study was to assess the feasibility and acceptability of training CHWs to provide primary level ear and hearing care, including: identification of patients with ear and hearing disorders, referral of patients to services, and treatment of simple ear conditions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear and hearing disorders,Ear, Nose and Throat
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 30/11/2015
Actual trial start date 30/11/2015
Anticipated date of last follow up 30/06/2016
Actual Last follow-up date 30/06/2016
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Stopped early/ terminated
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 we used a random number generator The number were generated by data officer who did not participate in field work Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Training Once off 3-day training using WHO manuals 3 days training using WHO manuals 30
Control Group No training at time of intervention Training was delayed for six months until after data collection at six months 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All Health surveillance assistants were eligible If they were from outside Thyolo district and not working in Thyolo district 29 Year(s) 55 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 26/03/2015 College of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mahtma Gandhi Road Blantyre Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome knowledge of ear and hearing care among CHWs after the training. Baseline and after training
Secondary Outcome number of patients with ear or hearing disorders identified by CHWs and number recorded at health centres during routine activities. six months after training
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Thyolo district Thyolo Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
College of Medicine NORHED project Mahtma Gandhi Road Blantyre Malawi
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor College of Medicine NORHED project Mahtma Gandhi Road Blantyre Malawi University
COLLABORATORS
Name Street address City Postal code Country
CIH, University of Bergen Haukelandsveien Bergen Norway
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Wakisa Mulwafu wmulwafu2@gmail.com +265999625734 Mahtma Gandhi Road
City Postal code Country Position/Affiliation
Blantyre Malawi Associate Professor
Role Name Email Phone Street address
Public Enquiries Wakisa Mulwafu wmulwafu2@gmail.com +265999625734 Mahtma Gandhi Road
City Postal code Country Position/Affiliation
Blantyre Malawi Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Charles Dzamalala comrec@medcol.mw +2651871911 Mahtma Gandhi Road
City Postal code Country Position/Affiliation
Blantyre Malawi
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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