Diabetes Clinical Trial
— CCMSDOfficial 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
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.
Status | Enrolling by invitation |
Enrollment | 600 |
Est. completion date | May 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of diabetes - All type 2 diabetics and type 1 diabetics with minimum of 5 years duration - Above 18 years of age Exclusion Criteria: - Diabetics below 18 years of age - Type 1 diabetics with duration of disease less than 5 years |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
South Africa | School of Health Systems and Public Health, University of Pretoria | Pretoria | Gauteng |
Lead Sponsor | Collaborator |
---|---|
University of Pretoria |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HbA1c values between year 1 and year 2 | 2 Years | No | |
Primary | Descriptive demographics of participants | 1 Year | No | |
Primary | Between group differences in patients with detected neuropathy, nephropathy and retinopathy | 2 Years | No | |
Primary | Between group differences in HbA1c categories | 1 year | No | |
Secondary | Between group differences in complications detected | 2 Years | No | |
Secondary | Between group differences in referred patients for complication assessment or care | 1 Year | No | |
Secondary | Between group differences in blood pressure and lipid control | 1 Year | No | |
Secondary | To cost the intervention and evaluate additional costs per complication detected | 1 Year | No | |
Secondary | 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 | No | |
Secondary | Between group differences in patients where LDL cholestrol and creatinine was measures | 2 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05594446 -
Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
|
||
Completed |
NCT03975309 -
DHS MIND Metabolomics
|
||
Completed |
NCT01855399 -
Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes
|
N/A | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
Recruiting |
NCT05007990 -
Caregiving Networks Across Disease Context and the Life Course
|
||
Active, not recruiting |
NCT04420936 -
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program
|
N/A | |
Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
Completed |
NCT04903496 -
Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
|
||
Completed |
NCT01437592 -
Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT03390179 -
Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Recruiting |
NCT05294822 -
Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
|
N/A | |
Completed |
NCT04427982 -
Dance and Diabetes/Prediabetes Self-Management
|
N/A | |
Completed |
NCT02356848 -
STEP UP to Avert Amputation in Diabetes
|
N/A | |
Completed |
NCT03292185 -
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
|
Phase 1 | |
Active, not recruiting |
NCT05477368 -
Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes
|
N/A | |
Completed |
NCT04496401 -
PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus
|
Phase 4 |