VOIES-D-ql - Qualitative Study on Experiences of Diabetes Care Delivery and Planning (VOIES-D-ql)

March 3, 2022 updated by: Hospices Civils de Lyon

VOIES-D-ql (Visualization for the Optimization of Interactions and Experiences in Healthcare Services in Diabetes Care)

Population aging and the increase in incidence and prevalence of potentially disabling chronic conditions make health care more and more complex and costly. In this context, timelines are longer and adherence to care provision and health status are more variable - both within and between patients - and care is provided by different health care professionals, as well as services outside the health system, which may work at various levels of service integration. For diabetes, this is especially the case: patients at high risk for multimorbidity interact with multiple health care professionals, such as primary care physicians, diabetes specialists, nurses, nutritionists and therapeutic educators, with different perspectives to treatment. The patient is frequently the only link between the different health care professionals, and very often the main source of information regarding performed procedures, diagnoses and treatment decisions.

A current challenge facing all health care stakeholders, including policy makers, practitioners, businesses, and patients, is to coordinate the available services and integrate care ensuring safety, effectiveness, and comprehensiveness in relation to the needs of individual users across the lifespan. Routine collected data can provide key information to completely assess a patient's health status and thus help evaluating and deciding adapted steps in treatment to stabilize or improve clinical outcomes.

In France, the Dossier Medical Partagé (Shared Medical Record) represents an effort to centralize and improve accessibility, to patients and professionals alike, of medical information. This system is yet little adopted and there is the need for added value initiatives to exploit the tool's potential. In other countries, like the UK, the governmental unit NHSX develops public policies and good practices for the digital transformation of the NHS. In the United States, working groups like the Health Information Technology Working Group, in the National Institute of Diabetes and Digestive and Kidney Diseases, develop electronic care plans using Electronic Health Record data for chronic kidney disease patients. These initiatives, among others, show the necessity of simple, visual communication in order to build a comprehensive care delivery pathway to inform decision and further care planning, according to health goals set by shared decision-making.

This study aims to describe individual experiences of chronic care delivery of people living with diabetes and also from healthcare professionals working in diabetes care from 3 different domains: clinical (relevant clinical criteria necessary for the decision-making process, goal setting and planning), technological (tools used in routine practice and in patients' daily lives), and behavioural (behaviours and interactions that build the patient's pathway and strategies implemented by patients and professionals to help the decision-making process).

Locations of the study : Primary and secondary healthcare facilities and patient associations in Lyon and Grenoble areas

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Laboratory HESPER EA 7425, University Claude Bernard Lyon 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People living with type 1 or type 2 diabetes recruited from Hospices Civils de Lyon or Centre Hospitalier Universitare Grenoble-Alpes, patient associations or online patient groups & HCPs

Description

Inclusion Criteria:

Patient

  • At least 18 years old
  • Diagnosed with type 1 or type 2 diabetes according to HAS criteria and confirmed by and endocrinologist since at least one year
  • Having had at least one consultation with a health care professional in the last 12 months
  • Able to communicate in French
  • Able to participate in an interview and not opposing to participate in the study

Professional

  • Having at least one year of professional experience in diabetes care
  • General practitioner, endocrinologist, diabetologist, intern, nurse, nutritionist or professional specialized in therapeutic education

Exclusion Criteria:

Patient

  • Inability to communicate in French
  • Institutionalized person

Professional

  • Professional not having had at least one consultation with a person living with diabetes in the last 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
People living with diabetes in Grenoble and Lyon areas
Eligible patients with type 1 or type 2 diabetes 1) during or after hospitalization for decompensation, ketoacidosis, or other emergency or elective interventions such as insulin pump installation, 2) followed in routine care in specialized diabetes services, 3) participating in patient associations.
Other: Description of patients' experiences of diabetes care delivery and planning
Semi-directed interviews will be conducted with people living with type 1 or type 2 diabetes in person or by phone to assess and describe the care delivery pathway they have been through. Information on 3 domains will be assessed: clinical (information they consider essential for health care professionals to systematically have access to during consultations and other health-related interventions such as therapeutic education sessions), technological (what kind of digital services and technologies they use or are willing to use), and behavioural (the decision-making process and the key interactions that build the care delivery pathway).
Health care professionals working in diabetes care in Grenoble
Health care professionals working with diabetes care in specialized services or ambulatory care.
Other: Description of health care professionals needs and experiences in diabetes care delivery and planning
Semi-directed interviews will be conducted with health care professionals working in diabetes care in person or by phone to assess and describe their needs and experiences in diabetes care. Information on 3 domains will be assessed: clinical (the information they consider to be essential to inform decisions in diabetes care, where and if they currently find that information and problems they might encounter), technological (which software they currently use and how data is input into clinical information systems), and behavioural (how care coordination is currently managed, how interactions with patients and other professionals are undertaken).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Description of individual experiences of patients and health care professionals in diabetes care.
Time Frame: The moment of the interview (Day 0)
Socioeconomic status will be assessed, health literacy using the Brief Health Literacy Screening (BHLS), and a semi-directed interview will be undertaken with people living with type 1 or type 2 diabetes. The latter aims t obtain a description of their experiences concerning how their care delivery pathways were built over time, how health-related decisions are made individually and what data they consider health care professionals they interact with should systematically have access to (considering the 3 domains previously described). Health care professionals will also be interviewed regarding their experiences and needs in diabetes care, in the shared decision-making process and in establishing care coordination.
The moment of the interview (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL19_0897

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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