NCT01902043

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,033

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 14, 2022

Status Verified

February 1, 2022

Enrollment Period

5.3 years

First QC Date

July 9, 2013

Last Update Submit

February 24, 2022

Conditions

Keywords

diabetes mellituscohort studyquality of carequality indicators, Health carequality of Health Careoutcome and process assessmenthealth services researchchronic diseases prevention and management

Outcome Measures

Primary Outcomes (1)

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

    Baseline and follow up once a year up to 10 years

Other Outcomes (2)

  • "Self-management support" measures (glycemic self-monitoring, participation in education classes/groups, self-efficacy, use of the diabetes passport)

    Baseline and follow up once a year up to 10 years

  • Knowledge of and participation in the activities/projects of the Programme cantonal Diabète (PcD)

    Baseline and follow up once a year up to 10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lausanne, Switzerland

Location

Related Publications (16)

  • 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]

    BACKGROUND
  • 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.

    PMID: 25621176BACKGROUND
  • 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.

    PMID: 24534326BACKGROUND
  • 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.

    PMID: 25759596BACKGROUND
  • 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.

    PMID: 28251768BACKGROUND
  • 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.

    PMID: 24737833BACKGROUND
  • 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.

    PMID: 28292557BACKGROUND
  • 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.

    PMID: 28292571BACKGROUND
  • 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.

    PMID: 28882117BACKGROUND
  • 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.

    PMID: 33691691BACKGROUND
  • 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]

    RESULT
  • 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.

  • 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.

  • 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.

  • 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.

  • Kosinski C, Zuercher E, Carron T, Chevallereau J, Le Pogam MA, Storari C, Wojtusciszyn A, Peytremann-Bridevaux I. Self-reported perceptions of adults with diabetes regarding their care and health in the time of COVID-19 pandemic in a Swiss region: a cross-sectional study. Swiss Med Wkly. 2024 Dec 5;154:3578. doi: 10.57187/s.3578.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Isabelle Peytremann Bridevaux, Professor

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 17, 2013

Study Start

September 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2022

Last Updated

March 14, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Locations