Type 2 DiabetesICCDNCT00945204
Evaluation of Intermediate Care Clinics for Diabetes
A study testing intermediate care clinics (ICCs) in people with Type 2 Diabetes, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
The aim of this trial is to assess the effectiveness of intermediate care clinics for diabetes, compared to usual care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- intermediate care clinics (ICCs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,997 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2007to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes from participating practices across NHS Leicester, Warwickshire and Coventry.
Who cannot join
- Patients unable to give informed consent,
- Terminal cancer, OR
- Pregnant.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Leicester
Leicester, Leicestershire, LE1 6TP
About this study
The aim of this trial is to assess the effectiveness of intermediate care clinics for diabetes, compared to usual care.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- intermediate care clinics (ICCs)
- Keywords
- type 2 diabetes, intermediate care, primary care, randomised controlled trial
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| access to intermediate care clinics | Experimental | Not described Receives: Other: intermediate care clinics (ICCs) |
| usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of participants reaching target control of HbA1c (7.0), and blood pressure (<140/80) and cholesterol (<4 mmol/l),
Measured: 18 months
Secondary outcomes (3)
Percentage of participants reaching target for individual risk factors (blood pressure, HbA1c or cholesterol)
Measured: 18 months
10 year risk for CHD and stroke assessed by the UKPDS risk engine
Measured: 18 months
Control of risk factors in all patients with type 2 diabetes in participating practices using anonymised routine data
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startMay 2007
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,997 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Medical School
- Responsible party
- Sponsor
- Investigators
- Andrew D Wilson, MD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945204
- Sponsor's protocol ID
- ICCD/NIHR SDO
- Acronym
- ICCD
- Status last verified
- Aug 2012
- First submitted
- 23 Jul 2009
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24736243Armstrong 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.
PubMed 22971356
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intermediate Care Clinics for Diabetes
- ClinicalTrials.gov ID
- NCT00945204
- Acronym / sponsor ID
- ICCD / ICCD/NIHR SDO
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, intermediate care, primary care, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,997 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- Warwick Medical School
- Study start
- May 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is to assess the effectiveness of intermediate care clinics for diabetes, compared to usual care.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| access to intermediate care clinics | Experimental | Other: intermediate care clinics (ICCs) |
| usual care | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with type 2 diabetes from participating practices across NHS Leicester, Warwickshire and Coventry.
Key exclusion criteria (3 listed)
- Patients unable to give informed consent,
- Terminal cancer, OR
- Pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | access to intermediate care clinics |
Primary outcome
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
3 secondary outcomes
Percentage of participants reaching target for individual risk factors (blood pressure, HbA1c or cholesterol)
Time frame: 18 months
10 year risk for CHD and stroke assessed by the UKPDS risk engine
Time frame: 18 months
Control of risk factors in all patients with type 2 diabetes in participating practices using anonymised routine data
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
- Derived from this study: PubMed 24736243Wilson 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.
- Derived from this study: PubMed 22971356Armstrong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew D Wilson, MD principal investigator
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermediate care clinics (ICCs) in people with Type 2 Diabetes, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00945204, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2012.