NCT00945204

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,997

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

4.4 years

First QC Date

July 23, 2009

Last Update Submit

August 7, 2012

Conditions

Type 2 Diabetes

Keywords

type 2 diabetesintermediate careprimary carerandomised controlled trial

Outcome Measures

Primary Outcomes (1)

  • The percentage of participants reaching target control of HbA1c (7.0), and blood pressure (<140/80) and cholesterol (<4 mmol/l),

    18 months

Secondary Outcomes (3)

  • Percentage of participants reaching target for individual risk factors (blood pressure, HbA1c or cholesterol)

    18 months

  • 10 year risk for CHD and stroke assessed by the UKPDS risk engine

    18 months

  • Control of risk factors in all patients with type 2 diabetes in participating practices using anonymised routine data

    18 months

Study Arms (2)

access to intermediate care clinics

EXPERIMENTAL
Other: intermediate care clinics (ICCs)

usual care

NO INTERVENTION

Interventions

intermediate care clinics (ICCs)OTHER

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.

access to intermediate care clinics

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leicester

Leicester, Leicestershire, LE1 6TP, United Kingdom

Location

Related Publications (2)

  • Wilson A, O'Hare JP, Hardy A, Raymond N, Szczepura A, Crossman R, Baines D, Khunti K, Kumar S, Saravanan P; ICCD trial group. Evaluation of the clinical and cost effectiveness of intermediate care clinics for diabetes (ICCD): a multicentre cluster randomised controlled trial. PLoS One. 2014 Apr 15;9(4):e93964. doi: 10.1371/journal.pone.0093964. eCollection 2014.

    PMID: 24736243DERIVED

  • Armstrong N, Baines D, Baker R, Crossman R, Davies M, Hardy A, Khunti K, Kumar S, O'Hare JP, Raymond N, Saravanan P, Stallard N, Szczepura A, Wilson A; ICCD Study Group. A cluster randomized controlled trial of the effectiveness and cost-effectiveness of intermediate care clinics for diabetes (ICCD): study protocol for a randomized controlled trial. Trials. 2012 Sep 12;13:164. doi: 10.1186/1745-6215-13-164.

    PMID: 22971356DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Andrew D Wilson, MD

    University of Leicester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

May 1, 2007

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

GB(1)