Diabete Type 1VOIES-D-qlNCT04217902
VOIES-D-ql - Qualitative Study on Experiences of Diabetes Care Delivery and Planning
An observational study of Diabete Type 1 and Diabete Type 2, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Diabete Type 1, Diabete Type 2
- What is being tested?
- Description of patients' experiences of diabetes care delivery and planning and Description of health care professionals needs and experiences in diabetes care delivery and planning
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 30 Jul 2021
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Laboratory HESPER EA 7425, University Claude Bernard Lyon 1
Lyon, 69003
About this study
Official title: 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.
Read more
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
- Conditions
- Diabete Type 1, Diabete Type 2
- Being tested
- Description of patients' experiences of diabetes care delivery and planning, Description of health care professionals needs and experiences in diabetes care delivery and planning
- Keywords
- Diabete Type 1, Diabete Type 2, Diabete Care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Description of patients' experiences of diabetes care delivery and planningOther
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).
Description of health care professionals needs and experiences in diabetes care delivery and planningOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Description of patients' experiences of diabetes care delivery and planning | |
| Health care professionals working in diabetes care in Grenoble | Health care professionals working with diabetes care in specialized services or ambulatory care. Receives: Other: Description of health care professionals needs and experiences in diabetes care delivery and planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of individual experiences of patients and health care professionals in diabetes care.
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.
Measured: The moment of the interview (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Jan 2021
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 1Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Other
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217902
- Sponsor's protocol ID
- 69HCL19_0897
- Acronym
- VOIES-D-ql
- Status last verified
- Mar 2022
- First submitted
- 2 Jan 2020
- Last updated
- 4 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VOIES-D-ql (Visualization for the Optimization of Interactions and Experiences in Healthcare Services in Diabetes Care)
- ClinicalTrials.gov ID
- NCT04217902
- Acronym / sponsor ID
- VOIES-D-ql / 69HCL19_0897
- Conditions
- Diabete Type 1, Diabete Type 2
- Keywords
- Diabete Type 1, Diabete Type 2, Diabete Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People living with diabetes in Grenoble and Lyon areas | – | Other: Description of patients' experiences of diabetes care delivery and planningEligible 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. |
| Health care professionals working in diabetes care in Grenoble | – | Other: Description of health care professionals needs and experiences in diabetes care delivery and planningHealth care professionals working with diabetes care in specialized services or ambulatory care. |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Description of patients' experiences of diabetes care delivery and planningSemi-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). | Other | People living with diabetes in Grenoble and Lyon areas |
| Description of health care professionals needs and experiences in diabetes care delivery and planningSemi-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). | Other | Health care professionals working in diabetes care in Grenoble |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 1 and Diabete Type 2, run by Hospices Civils de Lyon at 1 site in France.
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 4 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Description of individual experiences of patients and health care professionals in diabetes care. (time frame: The moment of the interview (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2022.