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.: PACTR201303000493351 Date of Approval: 05/02/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Diabetes and Hypertension CHC trial
Official scientific title Implimentation of national guidelines, incorporated within a structured diabetes and hypertension record, at primary level care in Cape Town. A RCT
Brief summary describing the background and objectives of the trial Diabetes and hypertension are poorly managed in the public health primary care sector. Clinical management guidelines for South Africa are available but are not implemented. A RCT will be conducted to evaluate an intervention for the implementation of guidelines at primary public sector clinics for hypertension and diabetes in order to improve control of these conditions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Diabetes, hypertension,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/01/1999
Actual trial start date 01/03/1999
Anticipated date of last follow up 30/09/2000
Actual Last follow-up date 30/11/2000
Anticipated target sample size (number of participants) 1080
Actual target sample size (number of participants) 1471
Recruitment status Completed
Publication URL http://dx.doi.org/10.3402/gha.v610.20796
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 randomisation Central randomistaion Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Multifaceted diabetes and hypertension clinical guideline implimentation 1 year A structured diabetes and hypertension records with prompts on guideline recommnedations was developed for patient's folder. It included 1) patient details, 2)educational topics 4) algorithm for diagnoses and management, 5) names and doses medication. Education programme for staff. Control clinics received usual care 18
Control Group Usual Care 1 year Usual care provied at community centres. Clinical guidelines passively distributed to clinics 18
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-15 years or older -Documented attendence of at least 4 vitits during the previous year for hypertension or diabetes -Having received treatment for these conditions -Patients who did not fulfil the inclusion critieria -Patients who were unable to answer the questions in the questionnaere -Patients who intended leaving the area during the coming year 15 Year(s) 70 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 Medical Research Council of South Africa
Ethics Committee Address
Street address City Postal code Country
PO Box 19070 Tygerberg 7505 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean glycate haemoglobin in diabetic patients and systolic and diasatolic BP in hypertensive patients At Baseline after 1 year of interventions
Secondary Outcome Proportion of patients with controlled glycaemia for patients with diabetes and controlled BP for patients with hypertension At baseline and after 1 year of interventions
Secondary Outcome Proportion of patients with complications of diabetes and hypertension in the relevant groups of patients Baseline and after 1 year of interventions
Secondary Outcome Number of patients folders that contained the structures record with prompts Baseline and after 1 year of interventions
Secondary Outcome Degree to which the structured record was completed Baseline and after1 year of interventions
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Guguletu Clinic NY3 Cape Town ---- South Africa
Lotus River Delia Road Cape Town ----- South Africa
Retreat 11th Ave Cape Twon ----- South Africa
Cross Roads Landsdown Rd Cape Town ---- South Africa
Dr Abdurahman Ebbenhout street Cape Town ----- South Africa
Bishop Lavis Lavis Drive Cape Town ------ South Africa
Bonteheuwel Street Cape Town ------ South Africa
Ocean View Carina Close Cape Town ----- South Africa
Hanover Park Street ----- South Africa
Macassar Hoepoe Street Cape Town --- South Africa
Grassy Park Victoria Road Cape Town ----- South Africa
Elsies River 26th Ave Cape Town ------ South Africa
Good Hope Justin Street Cape Town ----- South Africa
Woodstock Mountain Road Cape Town ----- South Africa
Ruyterwacht Vereniging Road Cape Town ----- South Africa
Belville South Kasselsvlei Road Cape Town ------ South Africa
Robbie Nurock Buitenkant Street Cape Town ------ South Africa
Guguletu Clinic many Cape Town many South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
South African Medical Research Council Fransie Van Zyl Drive Cape Town ------ South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Chronic Diseases of Lifestyle Unit, Medical Research Council South Africa Fransie Van Zyl Drive Cape Town ---- South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Dr Krisela Steyn MRC Fransie van Zyl Drive Cape Town ---- South Africa
Dr Naomi Levitt Old Groote Schuur Hospital Building Cape Town ---- South Africa
Ms Jean Fourie F
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator krisela steyn krisela.steyn@gmail.com -27-21-406 6802 Old Groote Schuur Hospital Building
City Postal code Country Position/Affiliation
Cape Town ------ South Africa Associate Director, Chronic Disease Initiative for Africa
Role Name Email Phone Street address
Public Enquiries Krisela Steyn krisela.steyn@uct.ac.za +27 21 406 6802 Old Groote Schuur Hospital building
City Postal code Country Position/Affiliation
Cape Town South Africa Associate Director, Chronic Disease Initiative for Africa
Role Name Email Phone Street address
Scientific Enquiries Krisela Steyn krisela.steyn@uct.ac.za +27 21 406 6802 Old Groote Schuur Hospital Building
City Postal code Country Position/Affiliation
Cape Town South Africa Associate Director, Chronic Disease Initiative for Africa
REPORTING
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