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The Efficacy of Specialist Collaboration and Mobile Screening for Improving the Management of Diabetes (CCMSD)

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ClinicalTrials.gov Identifier: NCT01275040
Recruitment Status : Unknown
Verified March 2011 by University of Pretoria.
Recruitment status was:  Enrolling by invitation
First Posted : January 12, 2011
Last Update Posted : March 24, 2011
Sponsor:
Information provided by:
University of Pretoria

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.


Condition or disease Intervention/treatment Phase
Diabetes Other: Mobile screening; Health Education Other: Health education Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2010
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : May 2012

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in HbA1c values between year 1 and year 2 [ Time Frame: 2 Years ]
  2. Descriptive demographics of participants [ Time Frame: 1 Year ]
  3. Between group differences in patients with detected neuropathy, nephropathy and retinopathy [ Time Frame: 2 Years ]
  4. Between group differences in HbA1c categories [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Between group differences in complications detected [ Time Frame: 2 Years ]
  2. Between group differences in referred patients for complication assessment or care [ Time Frame: 1 Year ]
  3. Between group differences in blood pressure and lipid control [ Time Frame: 1 Year ]
  4. To cost the intervention and evaluate additional costs per complication detected [ Time Frame: 1 Year ]
  5. 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 ]
  6. Between group differences in patients where LDL cholestrol and creatinine was measures [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01275040


Locations
South Africa
School of Health Systems and Public Health, University of Pretoria
Pretoria, Gauteng, South Africa, 0001
Sponsors and Collaborators
University of Pretoria
Investigators
Study Chair: Paul Rheeder, PhD School of Health Systems and Public Health, University of Pretoria, South Africa

Additional Information:
Responsible Party: Elize Webb, School of Health Systems and Public Health, University of Pretoria
ClinicalTrials.gov Identifier: NCT01275040     History of Changes
Other Study ID Numbers: SA-UP-61B/2010
First Posted: January 12, 2011    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: March 2011

Keywords provided by University of Pretoria:
diabetes
mobile screening
complications
primary care
specialised care
quality of care

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases