The Efficacy of Specialist Collaboration and Mobile Screening for Improving the Management of Diabetes
CCMSD
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
1 other identifier
interventional
600
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 7, 2010
CompletedFirst Posted
Study publicly available on registry
January 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMarch 24, 2011
March 1, 2011
1.8 years
June 7, 2010
March 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in HbA1c values between year 1 and year 2
2 Years
Descriptive demographics of participants
1 Year
Between group differences in patients with detected neuropathy, nephropathy and retinopathy
2 Years
Between group differences in HbA1c categories
1 year
Secondary Outcomes (6)
Between group differences in complications detected
2 Years
Between group differences in referred patients for complication assessment or care
1 Year
Between group differences in blood pressure and lipid control
1 Year
To cost the intervention and evaluate additional costs per complication detected
1 Year
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
1 Year
- +1 more secondary outcomes
Study Arms (2)
Mobile screening team
EXPERIMENTALThe Primary Health Care clinics where the mobile screening team will visit and active screening for DM complications will take place.
No mobile screening team
ACTIVE COMPARATORNo 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of diabetes
- All type 2 diabetics and type 1 diabetics with minimum of 5 years duration
- Above 18 years of age
You may not qualify if:
- Diabetics below 18 years of age
- Type 1 diabetics with duration of disease less than 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Health Systems and Public Health, University of Pretoria
Pretoria, Gauteng, 0001, South Africa
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Paul Rheeder, PhD
School of Health Systems and Public Health, University of Pretoria, South Africa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 7, 2010
First Posted
January 12, 2011
Study Start
June 1, 2010
Primary Completion
March 1, 2012
Study Completion
May 1, 2012
Last Updated
March 24, 2011
Record last verified: 2011-03