AzTrials
AzTrials

Diabetes MellitusCoDiab-VDNCT01902043

CoDiab-VD: a Population-based Cohort on Quality of Care of Patients With Diabetes in the Canton of Vaud (Switzerland)

An observational study of Diabetes Mellitus, run by University of Lausanne Hospitals at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Diabetes, one of the most prevalent chronic disease (~ 9% worldwide), represents a major public health burden in terms of morbidity, disability and mortality. Caring for patients with diabetes requires effective collaboration between healthcare providers, teamwork, self-management education and use of evidence-based… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus
How many people
1,033 participants
Where
1 siteSwitzerland
Study dates
Sep 2011to Dec 2022
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Non-institutionalized adult patients with diabetes (≥18 years, type 1 or 2 diabetes, disease duration ≥12 months) who were visiting the pharmacy with a prescription for oral antidiabetic drugs, insulin, glycemic strips or glucose meter, at the time of the recruitment, are eligible for this study.

Who may be able to join

  • Diagnosis of diabetes mellitus
  • Disease ≥ 12 months
  • Age ≥ 18 years
  • Residing in the canton of Vaud, Switzerland, non-institutionalized
  • Informed consent

Who cannot join

  • Gestational diabetes mellitus
  • Obvious cognitive impairment
  • Not speaking or understanding French well enough

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

    Lausanne

Other trials in Switzerland

About this study

Diabetes, one of the most prevalent chronic disease (~ 9% worldwide), represents a major public health burden in terms of morbidity, disability and mortality. Caring for patients with diabetes requires effective collaboration between healthcare providers, teamwork, self-management education and use of evidence-based medicine. However, these processes of care are complex and often suboptimal. Improving quality of diabetes care is thus needed to reduce the health and societal burden of this disease.

In the canton of Vaud, a state in Switzerland 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 data are available, they focus on intermediate outcomes as well as clinical and biological cardiovascular risk factors. Population-based data on patient-reported outcomes are not considered.

Read more

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 improving care for patients with diabetes.

To 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 the survey were to characterize patients with diabetes and assess the quality of the care they received. In addition, the results of the survey were used to help targeting unmet needs and possible areas of improvements, and constituted the patients' baseline measurement for the evaluation of the PcD.

The CoDiab-VD cohort emerged from that initial project; its specific objectives were 1) to follow over time the quality of diabetes care, 2) to explore topics that the PcD needed for its development, 3) to assess the impact of the PcD on the care of patients with diabetes, and 4) to evaluate the coverage of the PcD in the canton of Vaud.

Read the detailed description

Diabetes, one of the most prevalent chronic disease (~ 9% worldwide), represents a major public health burden in terms of morbidity, disability and mortality. Caring for patients with diabetes requires effective collaboration between healthcare providers, teamwork, self-management education and use of evidence-based medicine. However, these processes of care are complex and often suboptimal. Improving quality of diabetes care is thus needed to reduce the health and societal burden of this disease.

In the canton of Vaud, a state in Switzerland 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 data are available, they focus on intermediate outcomes as well as clinical and biological cardiovascular risk factors. Population-based data on patient-reported outcomes are not considered.

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 improving care for patients with diabetes.

To 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 the survey were to characterize patients with diabetes and assess the quality of the care they received. In addition, the results of the survey were used to help targeting unmet needs and possible areas of improvements, and constituted the patients' baseline measurement for the evaluation of the PcD.

The CoDiab-VD cohort emerged from that initial project; its specific objectives were 1) to follow over time the quality of diabetes care, 2) to explore topics that the PcD needed for its development, 3) to assess the impact of the PcD on the care of patients with diabetes, and 4) to evaluate the coverage of the PcD in 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 characteristics (type, disease duration, treatment, complications)
  • receipt of diabetes care: recommended process of care indicators (such as annual eye examination by ophthalmologist, foot examination, microalbuminuria…) , and specific outcomes of care (such as HbA1C levels, generic and specific (health-related) quality of life (SF-12 and ADDQoL))
  • congruence of care with the chronic care model (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 and were asked to fill a brief paper questionnaire requesting some clinical and laboratory data. Physicians were contacted in 2011, 2012 and 2014; physicians' follow-up was not repeated thereafter due to financial and logistic constraints.

Patients were contacted annually using paper follow-up questionnaires, consisting in a core set of questions similar to the baseline questionnaire. New questions were added and developed yearly according to the development and needs of the PcD. This allowed us to investigate these specific topics: diabetic foot in 2013; psychosocial outcomes related to diabetes and diabetes care in 2014; eyes and diabetes, as well as coordination and continuity of care in 2015; multimorbidity and needs for patient education in 2016; and pharmacy care in 2017.

A second recruitment, requested and financed by the funders, has been organized in 2017, in order to obtain a new population-based picture of diabetes in the canton of Vaud. It will allow 1) to compare data obtained at both recruitments, 2) to compare data obtained in 2017 from the second recruitment and from the annual follow-up of the first recruitment, and 3) to increase the number of patients with diabetes included in the CoDiab-VD cohort.

If requested by the PcD, additional follow-ups will take place in 2019 and in 2021.

Keywords
diabetes mellitus, cohort study, quality of care, quality indicators, Health care, quality of Health Care, outcome and process assessment, health services research, chronic diseases prevention and management
Medical subject headings
Diabetes Mellitus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Process of care indicators and the following outcomes of care: HbA1C, quality of life (QoL), Patient Assessment of Chronic Illness Care (PACIC)

    Measured: Baseline and follow up once a year up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2013 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2016
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,033 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01902043
Sponsor's protocol ID
CoDiab-VD-151/11
Acronym
CoDiab-VD
Status last verified
Feb 2022
First submitted
9 Jul 2013
Last updated
14 Mar 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Hagon-Traub I, Hirsiger P, Bovet P, Ruiz J, Peytremann-Bridevaux I, Noth C, Hauschild M. Programme cantonal Diabète, présentation du programme. Lausanne: Service de la Santé Publique du canton de Vaud; 2010. [http://www.vd.ch/fileadmin/user_upload/themes/sante_social/services_soins/Diabete/fichiers_pdf/Programme_cantonal.pdf]

  • Casillas A, Iglesias K, Flatz A, Burnand B, Peytremann-Bridevaux I. No consistent association between processes-of-care and health-related quality of life among patients with diabetes: a missing link? BMJ Open Diabetes Res Care. 2015 Jan 10;3(1):e000042. doi: 10.1136/bmjdrc-2014-000042. eCollection 2015.

    PubMed 25621176
  • Collet TH, Taffe P, Bordet J, Burnand B, Peytremann-Bridevaux I. Reproducibility of diabetes quality of care indicators as reported by patients and physicians. Eur J Public Health. 2014 Dec;24(6):1004-9. doi: 10.1093/eurpub/cku011. Epub 2014 Feb 17.

    PubMed 24534326
  • Flatz A, Casillas A, Stringhini S, Zuercher E, Burnand B, Peytremann-Bridevaux I. Association between education and quality of diabetes care in Switzerland. Int J Gen Med. 2015 Feb 25;8:87-92. doi: 10.2147/IJGM.S77139. eCollection 2015.

    PubMed 25759596
  • Gijs E, Zuercher E, Henry V, Morin D, Bize R, Peytremann-Bridevaux I. Diabetes care: Comparison of patients' and healthcare professionals' assessment using the PACIC instrument. J Eval Clin Pract. 2017 Aug;23(4):803-811. doi: 10.1111/jep.12720. Epub 2017 Mar 2.

    PubMed 28251768
  • Iglesias K, Burnand B, Peytremann-Bridevaux I. PACIC Instrument: disentangling dimensions using published validation models. Int J Qual Health Care. 2014 Jun;26(3):250-60. doi: 10.1093/intqhc/mzu042. Epub 2014 Apr 15.

    PubMed 24737833
  • Rosselet PC, Zuercher E, Pasquier J, Burnand B, Peytremann-Bridevaux I. Impact of forgoing care because of costs on the quality of diabetes care: A three-year cohort study. Eur J Intern Med. 2017 Jun;41:e35-e37. doi: 10.1016/j.ejim.2017.03.007. Epub 2017 Mar 11. No abstract available.

    PubMed 28292557
  • Zuercher E, Diatta ID, Burnand B, Peytremann-Bridevaux I. Health literacy and quality of care of patients with diabetes: A cross-sectional analysis. Prim Care Diabetes. 2017 Jun;11(3):233-240. doi: 10.1016/j.pcd.2017.02.003. Epub 2017 Mar 11.

    PubMed 28292571
  • Konstantinidis L, Carron T, de Ancos E, Chinet L, Hagon-Traub I, Zuercher E, Peytremann-Bridevaux I. Awareness and practices regarding eye diseases among patients with diabetes: a cross sectional analysis of the CoDiab-VD cohort. BMC Endocr Disord. 2017 Sep 7;17(1):56. doi: 10.1186/s12902-017-0206-2.

    PubMed 28882117
  • Bawab N, Zuercher E, Carron T, Chinet L, Bugnon O, Berger J, Peytremann-Bridevaux I. Interest in and use of person-centred pharmacy services - a Swiss study of people with diabetes. BMC Health Serv Res. 2021 Mar 10;21(1):216. doi: 10.1186/s12913-021-06217-6.

    PubMed 33691691
  • Peytremann-Bridevaux I, Bordet J, Zuercher E, Burnand B. Caractéristiques des patients diabétiques vaudois et évaluation de leur prise en charge : Rapport final (Recrutements 2011 et 2012). Lausanne : Institut universitaire de médecine sociale et préventive, 2013. (Raisons de santé, 211). [http://www.iumsp.ch/Publications/pdf/rds211_fr.pdf]

  • Peytremann-Bridevaux I, Bordet J, Burnand B. Diabetes care in Switzerland: good, but perfectible: a population-based cross-sectional survey. BMC Health Serv Res. 2013 Jun 25;13:232. doi: 10.1186/1472-6963-13-232.

    PubMed 23800376
  • Peytremann-Bridevaux I, Bordet J, Santschi V, Collet TH, Eggli M, Burnand B. Community-based pharmacies: an opportunity to recruit patients? Int J Public Health. 2013 Apr;58(2):319-22. doi: 10.1007/s00038-012-0383-8. Epub 2012 Jul 1. No abstract available.

    PubMed 22752242
  • Zuercher E, Bordet J, Burnand B, Peytremann-Bridevaux I. CoDiab-VD: protocol of a prospective population-based cohort study on diabetes care in Switzerland. BMC Health Serv Res. 2015 Aug 14;15:329. doi: 10.1186/s12913-015-0991-0.

    PubMed 26272346
  • Zuercher E, Casillas A, Hagon-Traub I, Bordet J, Burnand B, Peytremann-Bridevaux I. Baseline data of a population-based cohort of patients with diabetes in Switzerland (CoDiab-VD). Swiss Med Wkly. 2014 May 26;144:w13951. doi: 10.4414/smw.2014.13951. eCollection 2014.

    PubMed 24863132

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, run by University of Lausanne Hospitals at 1 site in Switzerland.

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 5 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: status not confirmed, as of the sponsor's last update on 14 Mar 2022. 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 Switzerland. 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?

Results are not available in the source record.

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?

Process of care indicators and the following 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 10 years). 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 NCT01902043, which also lists 16 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 14 Mar 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in