The Efficacy of Specialist Collaboration and Mobile Screening for Improving the Management of Diabetes (CCMSD)
A pragmatic cluster randomised controlled trial will be done where the intervention will be a mobile screening team visiting selected PHC facilities in Tshwane district. It will provide education and screening for diabetic complications (foot, kidney, cardiac and retinal complications). Six clinics will receive the intervention and six clinics will serve as controls. Six hundred patients will be recruited (2 x 300).
The screening results will be evaluated by an expert panel at tertiary care level and an individualised patient management plan will be compiled. This plan will be communicated to the family physician and integration team at the clinic for further management or referral of the patients. Laser therapy will be available on the mobile clinic for patients that require it (as assessed by an Ophthalmologist who will review the retinal photos).
A baseline evaluation (including HbA1c, serum creatinine, lipogram and urine albumin-creatinine ratio) will be done to determine current disease management at patient and health facility level, followed by the intervention and a follow-up visit a year later. The main outcome measures are glucose, lipid and blood pressure control as well as the percentage of patients screened and referred for diabetes complications.
A cost effectiveness analysis will be done to estimate the added cost per added complication prevented or referred.
The potential implications for improving diabetes care and preventing long term complications are extremely important. The study results will be used to help plan future health care services for people with diabetes mellitus in the region.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The Efficacy of Primary and Tertiary Specialist Care Collaboration and Mobile Complications Screening for Improving the Management of Diabetes at Primary Health Care Level in Tshwane District - A Cluster Randomized Trial|
- Change in HbA1c values between year 1 and year 2 [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- Descriptive demographics of participants [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- Between group differences in patients with detected neuropathy, nephropathy and retinopathy [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- Between group differences in HbA1c categories [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Between group differences in complications detected [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
- Between group differences in referred patients for complication assessment or care [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- Between group differences in blood pressure and lipid control [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- To cost the intervention and evaluate additional costs per complication detected [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- Collection of cross sectional data regarding complications and metabolic control from patients not enrolled in the trial but who are attending screening visits by the mobile team [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- Between group differences in patients where LDL cholestrol and creatinine was measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: Mobile screening team
The Primary Health Care clinics where the mobile screening team will visit and active screening for DM complications will take place.
Other: Mobile screening; Health Education
Active screening for diabetes complications - neuropathy screening, retinopathy screening, blood and urine tests. Health education for both patients and health workers on diabetes. Active collaboration between primary and tertiary care in the public health system.
Active Comparator: No mobile screening team
No mobile team will visit clinics and active screening for DM complications will not be done. Patients and Health Workers will receive Education, same as intervention arm but no enhanced care.
Other: Health education
Health education given to both patients and healthcare workers. No mobile screening team will visit facilities and no interaction between primary and tertiary care will be evaluated.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01275040
|School of Health Systems and Public Health, University of Pretoria|
|Pretoria, Gauteng, South Africa, 0001|
|Study Chair:||Paul Rheeder, PhD||School of Health Systems and Public Health, University of Pretoria, South Africa|