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Evaluation of Intermediate Care Clinics for Diabetes (ICCD)

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ClinicalTrials.gov Identifier: NCT00945204
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : August 8, 2012
Warwick Medical School
Information provided by (Responsible Party):
University Hospitals, Leicester

Brief Summary:
The aim of this trial is to assess the effectiveness of intermediate care clinics for diabetes, compared to usual care.

Condition or disease Intervention/treatment
Type 2 Diabetes Other: intermediate care clinics (ICCs)

Detailed Description:

Intermediate care clinics (ICC) are suggested as one method of improving care for people with type 2 diabetes, but their effectiveness and cost effectiveness is not known. Their aim is to provide a multidisciplinary community based service to support general practices in achieving good control of their patients. Two local PCTs (Leicester City and Warwickshire) have agreed to establish intermediate care clinics as part of a cluster randomised trial of their effectiveness.

Patients with type 2 diabetes in participating practices will be invited to take part. Those that agree will attend a baseline assessment by a study nurse. This will include measurement of HbA1C, body mass index, waist circumference, blood pressure, urine and lipids, as well as questionnaires about quality of life, satisfaction with current services and continuity of care. Practices will then be randomised to either usual care or intervention arms, the latter having access to the new clinics. Participating patients will be asked to attend a follow up assessment 18-24 months after the baseline assessments, when the same measurements will be repeated. We expect about 30% of patients in the intervention arm will have been referred to the ICC.

The primary outcome will be the percentage of patients achieving adequate control of HbA1, blood pressure and cholesterol, comparing all participants in the intervention and control arms, whether or not those in the intervention arm attended ICC. The study is powered to detect a 10% difference in this outcome, and will include 51 practices and 5100 patients. We will also examine the effect of the intervention on process measures, such as the number of contacts in hospital and general practice. In the intervention arm we will document in detail the inputs provided by ICC, so that if successful the model can be adopted elsewhere.

The economic evaluation will be undertaken from a societal perspective. A costing study will measure intervention and treatment costs in both groups. A comparative assessment of the marginal costs and outcomes of the intervention will be undertaken, to include cost-effectiveness ratios and cost-utility analysis. All findings will be subject to sensitivity analysis.

Additionally we will explore the views of patients in the intervention arm who attended ICC using semi-structures interviews to identify positive and negative aspects of the patients' experiences. We will also hold focus groups to explore views of professional stakeholders.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1997 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of Intermediate Care Clinics for Diabetes
Study Start Date : May 2007
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: access to intermediate care clinics Other: intermediate care clinics (ICCs)
The ICCs will be community based. Their aim is to support primary care, particularly smaller practices that have the most difficulty achieving good control. They will comprise a multidisciplinary team, and be led by specialist nurses who will place an emphasis on education and self management. Medical care will be provided by a diabetologist. The ICC will work closely with hospital based specialist teams and community services including podiatry and dietetics. Team members will work to local guidelines, adapted from national evidence based guidelines. Guidelines for referral to the ICCs will be common across all sites, and will include people with poorly controlled type 2 diabetes and those with poorly controlled cardiovascular risk factors.
No Intervention: usual care

Primary Outcome Measures :
  1. The percentage of participants reaching target control of HbA1c (7.0), and blood pressure (<140/80) and cholesterol (<4 mmol/l), [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Percentage of participants reaching target for individual risk factors (blood pressure, HbA1c or cholesterol) [ Time Frame: 18 months ]
  2. 10 year risk for CHD and stroke assessed by the UKPDS risk engine [ Time Frame: 18 months ]
  3. Control of risk factors in all patients with type 2 diabetes in participating practices using anonymised routine data [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with type 2 diabetes from participating practices across NHS Leicester, Warwickshire and Coventry.

Exclusion Criteria:

  • Patients unable to give informed consent,
  • Terminal cancer, OR
  • Pregnant.

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): NCT00945204

United Kingdom
University of Leicester
:Leicester, Leicestershire, United Kingdom, LE1 6TP
Sponsors and Collaborators
University Hospitals, Leicester
Warwick Medical School
Principal Investigator: Andrew D Wilson, MD University of Leicester

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT00945204     History of Changes
Other Study ID Numbers: ICCD/NIHR SDO
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012

Keywords provided by University Hospitals, Leicester:
type 2 diabetes
intermediate care
primary care
randomised controlled trial

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases