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.: PACTR201610001834198 Date of Approval: 25/10/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Piloting a mental health training programme for community health workers in Cape Town, Western Cape
Official scientific title Piloting a mental health training programme for community health workers in Cape Town, Western Cape, an exploration of changes in knowledge, attitude and confidence
Brief summary describing the background and objectives of the trial Non-adherence to treatment in mental illness is a serious problem; with only half of mental health service users (MHSU) prescribed antipsychotic medication being compliant to treatment. Discontinuation of antipsychotic treatment results in high rates of relapse, which in turn leads to increased morbidity and decreased quality of life, with increased demand on hospital services. There is thus much interest in exploring interventions aimed at improving adherence and outcomes for MHSU. Little is known about whether community health worker (CHW) training programs focused on mental health result in improved knowledge, confidence and a change in attitudes towards mental illness. This study seeks to explore whether the training of CHW¿s with due consideration of these factors succeeds in up skilling them to effectively provide adherence and basic social support pertinent to mental illness
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Mental Illness
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/06/2016
Actual trial start date 21/06/2016
Anticipated date of last follow up 15/11/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Completed
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 Non-randomised No concealment. CHW groups to receive training were selected by the relevant sub-distrcits in the Western Cape Department of Health Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mental Health Training 8 Weekly Sessions 3 Hours per session An 8-session (1 session per week for 8 weeks) training program in mental health literacy and management in line with the South African national framework for community health worker training. 40
Control Group No mental health training Not applicable Not applicable This group consists of CHW's who have not yet received structured mental health training. 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
CHWs already employed and mandated by the Western Cape Department Of Health to provide home based care and adherence support under the supervision of various non-profit organizations within the Cape Town metropole. There no exclusion criteria. 17 Year(s) 65 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 15/01/2016 University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room E52-24 Old Main Building, Groote Schuur Hospital, Observatory Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knowledge Measured in 8th Training session through case vignettes. Measured 3 months after the end of the training through the use of case vignettes.
Primary Outcome Service impact Measured at the end of the second case vignettes, reviewing data on referral and service quality. This data will be reviewed historically from before the start of the training program to the date of review case vignettes.
Secondary Outcome Feasibility and acceptibility of the intervention. During the course of the intervention through daily evaluation questionnaires and observation. At the end of the training program by way of a program evaluation questionnaire.
Secondary Outcome Changes in attitude and confidence Attitudes and confidence measured at the start of the training through the use of a questionnaire. Same questionnaire administered at the end of the training to elicit any change.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Caring Network Khayelitsha 486b Section F, Luvuyo Crescent, Khayelitsha Cape Town 7784 South Africa
Arisen Women Foundation 4 Hugo Naude Street New Woodlands, Mitchells Plain Cape Town 7785 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Medical Research Council Unit on Anxiety and Stress Disorders J-Block Groote Schuur Hospital, Anzio Road, Observatory Cape Town 7925 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor South African Medical Research Council on Anxiety and Stress Disorders J-Block Groote Schuur Hospital, Anzio Road, Observatory Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Goodman Sibeko Education Centre, Valkenberg Hospital, Observatory Road, Observatory Cape Town 7925 South Africa
Peter Milligan Education Centre, Valkenberg Hospital, Observatory Road, Observatory Cape Town 7925 South Africa
Marinda Roelofse First floor, Norton Rose, Thibault Square, 8 Riebeeck Street Cape Town 8001 South Africa
Lezel Molefe 35 Plaza, Corma Street, Sirocco village, Bellville Cape Town 7530 South Africa
Crick Lund 46 Sawkins Road, Rondebosch Cape Town 7700 South Africa
Dan Stein J-Block Groote Schuur Hospital, Anzio Road, Observatory Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Goodman Sibeko goodmansibeko@gmail.com 0214403111 Education Centre, Valkenberg Hospital, Observatory Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa PhD Student, University of Cape Town
Role Name Email Phone Street address
Public Enquiries Goodman Sibeko goodmansibeko@gmail.com 0214403111 Education Centre, Valkenberg Hospital, Observatory Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa PhD Student, University of Cape Town
Role Name Email Phone Street address
Scientific Enquiries Goodman Sibeko goodmansibeko@gmail.com 0214403111 Education Centre, Valkenberg Hospital, Observatory Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa PhD Student, University of Cape Town
REPORTING
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