Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Sponsor University of Lausanne Hospitals
Collaborator Service de la santé publique, Canton de Vaud
Start date September 2011
End date December 2015
Trial size 519 participants
Trial identifier NCT01902043, CoDiab-VD-151/11

Summary

Chronic disease care requires good collaboration between healthcare providers, teamwork, self-management education and use of evidence-based medicine. However, such care process is complex and often suboptimal. Diabetes, a prevalent chronic disease (~ 9% worldwide) which represents a major public health burden in terms of morbidity, disability and mortality, is not an exception. Individuals with diabetes, require more health care resources than people without diabetes. Improving quality of diabetes care is especially needed to reduce the health and societal burden of this disease.

In the canton of Vaud, Switzerland, a state with more than 700,000 inhabitants, a recent population-based study has shown that the prevalence of diabetes was around 7%. Data on the quality of diabetes care is scarce and quality of care data are still infrequently and unsystematically collected in Switzerland. In addition, when they are available, they rather focus on intermediate outcomes as well as clinical and biological cardiovascular risk factors. Also, they are not population-based and do not consider patient-reported outcomes.

In 2010, the Public Health Department of the canton of Vaud initiated the development of a regional diabetes program entitled "Programme cantonal Diabète" (PcD). It aimed both at decreasing the incidence of diabetes and at improving care for patients with diabetes.

To better tailor the program to the healthcare needs of patients and healthcare professionals involved in diabetes care, an exploratory study using qualitative methods was conducted in 2010. This was followed by a population-based survey conducted in fall 2011 and summer 2012. The objectives of this survey were to characterize patients with diabetes and assess the quality of the care they received. In addition, to help targeting unmet needs and possible areas of improvements, the results of this survey also constituted the baseline patients' measurement of the evaluation of the PcD.

The CoDiab-VD cohort emerged from that initial project. Its specific objectives are 1) to follow over time quality of diabetes care, 2) to assess the impact of the PcD on care of patients with diabetes, and 3) to evaluate the coverage of the PcD within the canton of Vaud.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Process of care indicators and outcomes of care: HbA1C, quality of life (QoL), Patient Assessment of Chronic Illness Care (PACIC)
time frame: Baseline and follow up once a year up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of diabetes mellitus - Disease > 12 months - Age > 18 years - Residing in the canton of Vaud, Switzerland, non-institutionalized - Informed consent Exclusion Criteria: - Gestational diabetes mellitus - Obvious cognitive impairment - Not speaking or understanding French well enough

Additional Information

Official title CoDiab-VD: a Population-based Cohort on Quality of Care of Patients With Diabetes in the Canton of Vaud (Switzerland)
Principal investigator Isabelle Peytremann Bridevaux, Professor
Description Chronic disease care requires good collaboration between healthcare providers, teamwork, self-management education and use of evidence-based medicine. However, such care process is complex and often suboptimal. Diabetes, a prevalent chronic disease (~ 9% worldwide) which represents a major public health burden in terms of morbidity, disability and mortality, is not an exception. Individuals with diabetes, require more health care resources than people without diabetes. Improving quality of diabetes care is especially needed to reduce the health and societal burden of this disease. In the canton of Vaud, Switzerland, a state with more than 700,000 inhabitants, a recent population-based study has shown that the prevalence of diabetes was around 7%. Data on the quality of diabetes care is scarce and quality of care data are still infrequently and unsystematically collected in Switzerland. In addition, when they are available, they rather focus on intermediate outcomes as well as clinical and biological cardiovascular risk factors. Also, they are not population-based and do not consider patient-reported outcomes. In 2010, the Public Health Department of the canton of Vaud initiated the development of a regional diabetes program entitled "Programme cantonal Diabète" (PcD). It aimed both at decreasing the incidence of diabetes and at improving care for patients with diabetes. To better tailor the program to the healthcare needs of patients and healthcare professionals involved in diabetes care, an exploratory study using qualitative methods was conducted in 2010. This was followed by a population-based survey conducted in fall 2011 and summer 2012. The objectives of this survey were to characterize patients with diabetes and assess the quality of the care they received. In addition, to help targeting unmet needs and possible areas of improvements, the results of this survey also constituted the baseline patients' measurement of the evaluation of the PcD. The CoDiab-VD cohort emerged from that initial project; its specific objectives are 1) to follow over time quality of diabetes care, 2) to assess the impact of the PcD on care of patients with diabetes, and 3) to evaluate the coverage of the PcD within the canton of Vaud. Patients with diabetes were recruited by community-based pharmacies in the fall of 2011 and the summer of 2012. Participating community-based pharmacies, randomly contacted among those registered in the canton of Vaud, were asked to recruit non-institutionalized adult patients with diabetes (disease duration of at least 12 months), who were visiting the pharmacy with a prescription for oral antidiabetic drugs, insulin, glycemic strips or glucose meter. At baseline, patients filled in a self-reported paper questionnaire that targeted the following areas: - diabetes (type, disease duration, treatment, complications) - current diabetes care: recommended process of care indicators, such as annual eye examination by ophthalmologist, foot examination, microalbuminuria, …, and specific outcomes of cares such as HbA1C levels, quality of life (SF-12 and ADDQoL) - patient assessment of care (PACIC) - healthcare utilization - health behaviors (smoking and drinking habits, physical activity) and health status (comorbidities) - self-management support (for example glycemic self-monitoring, self-efficacy, information level about diabetes) - sociodemographic characteristics (age, gender, nationality, place of residence, education, employment, marital status, family size, family income, insurance status). Participants were also asked to give the contact details of their family doctor and/or diabetologist. With the consent of the patients, treating physicians were contacted. Those accepting to participate filled in a brief paper questionnaire asking for few clinical and laboratory data. A follow-up, using paper questionnaires, will be organized. While patients will be contacted every year, physicians will be contacted every two years. Patients' follow-up paper questionnaires will be constituted of a core set of questions identical to the baseline questionnaire. New questions will be added and developed according to the development and needs of PcD.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Lausanne Hospitals.