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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Pretoria
ClinicalTrials.gov Identifier:
NCT01275040
First received: June 7, 2010
Last updated: March 23, 2011
Last verified: March 2011
  Purpose

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 Intervention
Diabetes
Other: Mobile screening; Health Education
Other: Health education

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Pretoria:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
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)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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
Study First Received: June 7, 2010
Last Updated: March 23, 2011
Health Authority: South Africa: Academic Advisory Committee of Faculty of Health Sciences, University of Pretoria
South Africa: Faculty of Health Sciences Research Ethics Committee, University of Pretoria

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

ClinicalTrials.gov processed this record on August 28, 2014