Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/02/2010
Date assigned
03/03/2010
Last edited
15/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.hausarztmedizin.uzh.ch

Contact information

Type

Scientific

Primary contact

Dr Anja Frei

ORCID ID

Contact details

Institut für Hausarztmedizin der Universität Zürich
Universitätsspital Zürich
Sonneggstrasse 6
Zürich
8091
Switzerland
+41 (0)44 255 87 11
anja.frei@usz.ch

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The chronic care for diabetes study (CARAT): A cluster randomised controlled trial

Acronym

CARAT

Study hypothesis

The implementation of several elements of the Chronic Care Model (CCM) via a specially trained practice nurse improves the HbA1c level of diabetes type II patients in small, single handed practices in Switzerland significantly after one year (estimated change: 0.5% in HbA1c) and increases the proportion of patients who achieve the recommended targets regarding blood pressure (<130/80), HbA1c (=<6.5) and LDL-cholesterol (<1.8 mmol/l) significantly. Furthermore, this implementation improves patients’ quality of life, and several evidence based quality indicators for diabetes care. Finally, these improvements in care, aiming at a better accordance with the CCM, will be experienced by the patients as well as by the practice team.

Ethics approval

The ethics board of the Kanton Zurich (Kantonale Ethik-Kommission Zürich) approved on the 25th of January 2010 (KEK-ZH-NR: 2009-0094/1)

Study design

Single centre cluster-randomised open label two-armed interventional study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Diabetes type II; primary care

Intervention

1. Practices in the control group:
Treatment as usual (patients will be treated by the GP as usual)

2. Practices in the intervention group:
2.1. Intervention on the practice nurse:
Participation in a 6-day educational course “Treatment of long term patients - module diabetes” (“Betreuung von Langzeitpatienten - Modul Diabetes“) organised by the “Schweizerischer Verband medizinischer Praxisassistentinnen” (18 - 24/04/2010): Content: treatment of diabetes patients (medical basics, diet, practical tips, communication etc.), role of the practice nurse in a team providing structured care for chronically ills, how to perform a follow-up with the CARAT-monitoring-tool
2.2. Intervention on the GPs:
Two interactive workshops of 4 hours (second 2 hours together with the practice nurses):
2.2.1. Evidenced based treatment of diabetes in a primary care setting, implementing structured and proactive care according to the Chronic Care model in practice (29/04/2010)
2.2.2. Exchange of experience and cardiovascular risk management (autumn 2010)
3. Intervention on the team:
One outreach visit will be performed by a study nurse of the study centre after completing the courses for GPs and practice nurses. The aims are to assess if the structures in the practices are appropriate to perform care according to this study protocol, to reveal possible problems which might have occurred, to discuss and implement appropriate solutions, and to check that the CARAT-tool is used as intended.
4. Intervention on the patient:
Patients will be treated by the special trained practice nurse in conjunction with the GP, treatment will be structured according to the Chronic Care Model.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Glycated Haemoglobin (HbA1c) level, measured at baseline (T0) and 1 year (T1)

Secondary outcome measures

All measures will be assessed at baseline (T0) and 1 year (T1):

1. Guideline adherence (recommended treatment goals): Proportion of patients who achieve the recommended targets regarding:
1.1. HbA1c (=<6.5)
1.2. Blood pressure (<130/80)
1.3. Low-density lipoprotein-cholesterol (LDL-cholesterol) (<1.8 mmol/l)
2. Quality of Life, assessed by SF-36 questionnaire
3. Process quality:
3.1. Proportion of patients receiving at least one eye examination per year
3.2. Proportion of patients receiving at least one food examination per year
3.3. Proportion of patients receiving at least one nephropathy screening per year
3.4. Proportion of patients receiving at least one neurological testing per year
4. Accordance to the Chronic Care Model:
4.1. Patient Assessment of Chronic Illness Care questionnaire (PACIC-5A)
4.2. Assessment of Chronic Illness Care questionnaire (ACIC)

Overall trial start date

01/01/2010

Overall trial end date

01/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diabetes type II patients (Glucose in blood plasma > 7,0 mmol /l)
2. At least one measure of HbA1c > 7.0% within the last year
3. Aged older than 18 years
4. Male and female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12 patients and 14 practices are recruited in each arm (target total recruitment number 336). Randomisation at GP level.

Participant exclusion criteria

1. Insufficient German language skills
2. Patients who contacted the practice for emergencies only or as a substitute practice
3. Patients with oncological diseases and/or an estimated life expectancy of less than six months due to severe diseases

Recruitment start date

01/01/2010

Recruitment end date

01/05/2011

Locations

Countries of recruitment

Switzerland

Trial participating centre

Institut für Hausarztmedizin der Universität Zürich
Zürich
8091
Switzerland

Sponsor information

Organisation

Institute of General Practice Medicine - University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switerland)

Sponsor details

University Hospital of Zurich
Sonneggstrasse 6
Zürich
8091
Switzerland
+41 (0)44 255 98 55
thomas.rosemann@usz.ch

Sponsor type

University/education

Website

http://www.hausarztmedizin.uzh.ch

Funders

Funder type

University/education

Funder name

Institute of General Practice Medicine - University of Zurich (Institut für Hausarztmedizin der Universität Zürich) (Switerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swiss Academy for Medical Sciences (SAMW) (Switzerland) (grant number RRMA 8-09)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Menarini AG (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20550650
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22704274

Publication citations

  1. Protocol

    Frei A, Chmiel C, Schläpfer H, Birnbaum B, Held U, Steurer J, Rosemann T, The Chronic CARe for diAbeTes study (CARAT): a cluster randomized controlled trial., Cardiovasc Diabetol, 2010, 9, 23, doi: 10.1186/1475-2840-9-23.

  2. Results

    Frei A, Herzog S, Woitzek K, Held U, Senn O, Rosemann T, Chmiel C, Characteristics of poorly controlled Type 2 diabetes patients in Swiss primary care., Cardiovasc Diabetol, 2012, 11, 70, doi: 10.1186/1475-2840-11-70.

Additional files

Editorial Notes