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.: PACTR201205000380384 Date of Approval: 07/05/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of a group diabetic education programme using motivational interviewing in underserved communities in South Africa
Official scientific title Effectiveness of a group diabetic education programme using motivational interviewing in underserved communities in South Africa: Pragmatic cluster randomized control trial
Brief summary describing the background and objectives of the trial In South Africa the quality of diabetes care is generally poor and education is performed in an ad hoc and unpredictable manner. This project intends to evaluate a structured group educational programme, supported by appropriate educational materials and delivered by health promoters who have been trained in better communication (motivational interviewing). This approach has never been evaluated in our context and if effective can be implemented widely.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Diabetes
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/09/2010
Actual trial start date 01/09/2010
Anticipated date of last follow up 30/11/2011
Actual Last follow-up date 30/11/2011
Anticipated target sample size (number of participants) 1360
Actual target sample size (number of participants) 1570
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
ST09-040 BRIDGES: International Diabetes Federation
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 Health centres were randomised (clusters) by means of a randomisation table in a computer software programme Clusters (health centres) and not individual participants were randomised Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Health centres were randomised (clusters) by means of a randomisation table in a computer software programme Clusters (health centres) and not individual participants were randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group diabetes education 4 sessions 4-6 months Group diabetes education delivered by a health promoter to 10-15 diabetic patients. Four sessions were planned with associated educational resources and using a guiding style (motivational interviewing) 710
Control Group Control/Standard of Care Standard Care standard standard care 850 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All type 2 diabetic patients who give consent, regardless of the type of medication (oral and/or insulin). Type 1 diabetic patients, those who refuse consent, those who are judged by the clinical nurse practitioner or medical officer as unable to participate in the intervention (for example due to acute illness, mental illness, dementia or another justifiable reason). 18 Year(s) 100 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 07/09/2009 Health Research Ethics Committee, Stellenbosch University
Ethics Committee Address
Street address City Postal code Country
Box 19063 Cape Town 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Diabetes self care activities Baseline and 12 months
Secondary Outcome Diabetes-specific self-efficacy Baseline and 12 months from baseline
Secondary Outcome Locus of control Baseline and 12 months from baseline
Secondary Outcome Mean blood pressure Baseline and 12 months from baseline
Secondary Outcome Mean weight loss Baseline and 12 months from baseline
Secondary Outcome Mean HbA1c Baseline and 12 months from baseline
Secondary Outcome Mean total cholesterol Baseline and 12 months from baseline
Secondary Outcome Quality of life Baseline and 12 months from baseline
Primary Outcome HbA1c reduction of 1 percentage point Baseline and 12 months
Primary Outcome 5 percent weight loss Baseline and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Guguletu CHC Cape Town, Gugulethu CHC
Delft CHC Cape Town, Delft CHC
Dirkie Uys CHC Cape Town, Dirkie Uys CHC
Scottsdene CHC Cape Town, Scottsdene CHC
Bellville Reid St. CHC Bellville, Cape Town, Reed St CHC
Bishop Lavis CHC Bishop Lavis, Cape Town
Ruyterwacht CHC Cape Town, Ruyterwacht CHC
Durbanville CHC Cape Town, Durbanville CHC
Vanguard CHC Cape Town, Vanguard CHC
Retreat CHC Cape Town, Retreat CHC
Lotus River CHC Cape Town, Lotus River
Albow Gardens CHC Milnerton, Cape Town
Hout Bay CHC Hout Bay, Cape Town
Michael Mapongwana CHC Khayalitsha, Cape Town
Khayelitsha CHC Khayelitsha, Cape Town
Kleinvlei CHC Cape Town
Mfuleni CHC Mfuleni, Cape Town
Macassar CHC Macassar, Cape Town
Nyanga CHC Nyanga, Cape Town
CrossRoads II CHC Khayelitsha, Cape Town
Heideveld CHC Heideveld, Cape Town
Mitchells Plain CHC Mitchells Plain, Cape Town
Elsies River CHC Elsies River, Cape Town
Kraaifontein CHC Kraaifontein, Cape Town
Ravensmead CHC Ravensmead, Cape Town
Bellville CHC Bellville, Cape Town
Lady Michaelis CHC Plumstead, Cape Town
Grassy Park CHC Grassy Park, Cape Town
Woodstock CHC Woodstock, Cape Town
Nolungile CHC Cape Town, Nolungile CHC
Nzamazabantu CHC Capet Town, Nzamazabantu
Hanover Park CHC Cape Town, Hanover Park CHC
Dr Abdurahman CHC Cape Town, Dr Abdurahman CHC
FUNDING SOURCES
Name of source Street address City Postal code Country
Stellenbosch University Box 19063 Tygerberg 7505 South Africa
BRIDGES: International Diabetes Federation Chaussée de la Hulpe 166 Brussels B- 1170 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Stellenbosch University Box 19063 Tygerberg 7505 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Department of Health 4 Dorp St Cape Town 8000 South Africa
Chronic Diseases Initiative in Africa Groote Schuur Hospital, Main Rd Cape Town 7925 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Robert Mash rm@sun.ac.za 0219389170 Box 19063
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa Head: Family Medicine and Primary Care, Stellenbosch University
Role Name Email Phone Street address
Public Enquiries Sister Hilary Rhode hrhode@sun.ac.za 0219389169 Box 19063
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa Lecturer and researcher: Division of family medicine and Primary Care, Stellenbosch University
Role Name Email Phone Street address
Scientific Enquiries Robert Mash rm@sun.ac.za 0219389170 Box 19063
City Postal code Country Position/Affiliation
Tygerberg 7505 South Africa Head: Family Medicine and Primary Care, Stellenbosch University
REPORTING
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