Plain English Summary
Not provided at time of registration
Trial website
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
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
-
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.
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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.