Type 2 DiabetesNCT05226182
Visualisation of a Digital Care Pathway.
A study testing visualisation of a digital care path in people with Type 2 Diabetes and Multidisciplinary Communication, run by Jessa Hospital at 1 site in Belgium.
Trial summary
As part of the EFRO (Europees Fonds Regionale Ontwikkeling) 1302 project "Digital Care Support in Practice with Limburg as a Stepping Stone for Flanders", this study aims to evaluate the concept and added value of visualising a personal digital care pathway for patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Multidisciplinary Communication, Empowerment
- What is being tested?
- visualisation of a digital care path
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2021to 30 Jun 2022
- Phase
- Interventional
- 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
Who may be able to join
- patients with type 2 diabetes (voortraject and zorgtraject)
- independent and mentally competent
- digitally literate and in possession of an email address
- mastered the Dutch language
- able to visit the GP (no house calls)
- Additional inclusion criteria for cohort 2 :
- presence of a home nurse in the context of the Diabetes care
- presence of a home care service
Who cannot join
- patients type 2 Diabetes enrolled in the Diabetes convention
- pregnant patients
- illiterate people
- patients living in a residential care center
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Jessa Hospital
Hasselt, Limburg, 3500
Emilie Weyens, emilie.weyens@jessazh.be
Jolien Nelissen, Dr., jolien.nelissen@jessazh.be
About this study
Official title: Visualisation of a Digital Care Pathway in Limburg, in Context of Digital Care Support as a Stepping Stone for Flanders.
As part of the EFRO (Europees Fonds Regionale Ontwikkeling) 1302 project "Digital Care Support in Practice with Limburg as a Stepping Stone for Flanders", this study aims to evaluate the concept and added value of visualising a personal digital care pathway for patients with type 2 diabetes. Firstly, this chronological visualisation of data strives to improve patient experience and empowerment by offering educational articles and personal medical data relevant to their care path in one place. This way, patients will have more insight in the pathogenesis, treatments, complications and goals, allowing the patients to optimize their selfcare and become confident in dealing with their chronic condition. From time to time, patients will also be asked to complete questionnaires concerning their experiences (PREM) to aid healthcare professionals in personalizing treatment goals. Secondly, the healthcare providers and caregivers surrounding the patient will also have access to the same data, allowing for a more personal approach as well as means to communicate with other members of the care team.
Read the detailed description
Good quality of care requires a multidisciplinary approach, especially with chronic illnesses. Therefore, all members of the care team should be adequately informed and communicate well with each other. Additionally, patients should have a key role in their treatment plan. To successfully optimize self care, patients have to be well-informed about pathogenesis, treatments and complications so that expectations are realistic and attainable goals can be set. Currently, access to this relevant data is fragmented and often unavailable.
The newly developed application creates a central platform where all relevant data, educational material, medication scheme... are available for both the patient and healthcare professionals. The targeted study population are patients with type 2 diabetes who will be recruited by their general practitioner (GP) over a period of 3 months. When patients are interested in partaking, they will be contacted by a healthcare professional who will function as a Single Point of Contact (SPOC) for the patient during the entirety of the study with a maximum duration of 6 months. The SPOC helps with the start up of the application, collects administrative data and contacts the participants at regular intervals to help with difficulties in using the application. Furthermore, the SPOC will administer a questionnaire determining patient involvement and experience at the start and end of the study, as well as conduct an in-depth interview when the study is completed. Throughout the study, other questionnaires will be digitally available for the patient as part of the care path. These patient reported outcome and experience measures (PROM/PREM) will support healthcare professionals in providing a more integral care.
Consequently, involved healthcare professionals will also be contacted, informed and asked to complete a questionnaire once healthcare professionals agree to participate in the study. This questionnaire will focus on the information and communication needs between members of the care team and will also be repeated at the end, followed by an in-depth interview.
- Conditions
- Type 2 Diabetes, Multidisciplinary Communication, Empowerment, Patient Empowerment, Patient Acceptance of Health Care
- Being tested
- visualisation of a digital care path
- Keywords
- digital, care, pathway, type 2, Diabetes, visualization, E-health, pilot study, visualisation
- Medical subject headings
- Diabetes Mellitus, Type 2, Empowerment, Patient Participation, Patient Acceptance of Health Care, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visualisation of a digital care pathOther
The implementation and visualisation of a digital care path, specifically designed for patients with type 2 diabetes and their care team. The digital care path wil include: 1) a timeline with appointments, messages and questionnaires 2) Diabetes related articles 3) a page for monitoring clinical parameters and goals 4) a section displaying information on their care team and personal health records. The aim of this intervention is to evaluate whether providing a central platform for all data will increase patient empowerment and involvement. Secondly it will also evaluate whether the communication between healthcare professionals improves when selected data is readily available for the entire care team.
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Implementation and visualisation of digital care path. Pre measurement: questionnaire quantifying patient involvement and experience on a 5-p Likert scale.
Post measurement: questionnaire quantifying patient involvement and experience on a 5-p Likert scale, questionnaire quantifying usability of the tool and in-depth interview. Receives: Other: visualisation of a digital care path |
| healthcare professionals | Experimental | Implementation and visualisation of digital care path. Pre measurement: questionnaire quantifying communication needs and experiences on a 5-p Likert scale.
Post measurement: questionnaire quantifying communication needs and experiences on a 5-p Likert scale, questionnaire quantifying usability of the tool and in-depth interview. Receives: Other: visualisation of a digital care path |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient empowerment and involvement
Primary outcome measures will be determined with the aid of a questionnaire scoring answers on a 5p-Likert scale. Due to limited availability of validated questionnaires in Dutch, a custom set of questions was generated. Starting from validated English questionnaires on each topic, the Delphi method was used to reach consensus in selecting the final questions.
At the end of the study, an in-depth interview will take place with a predefined topic list.
Measured: For a minimum of 12 weeks
Change in care team communication and sharing of data
Primary outcome measures will be determined with the aid of a questionnaire scoring answers on a 5p-Likert scale. Due to limited availability of validated questionnaires in Dutch, a custom set of questions was generated. Starting from validated English questionnaires on each topic, the Delphi method was used to reach consensus in selecting the final questions.
At the end of the study, an in-depth interview will take place with a predefined topic list.
Measured: For a minimum of 12 weeks
Usability and acceptance of the application in patients and healthcare professionals
Primary outcome measures will be determined with the aid of a questionnaire scoring answers on a 5p-Likert scale. Due to limited availability of validated questionnaires in Dutch, a custom set of questions was generated. Starting from validated English questionnaires on each topic, the Delphi method was used to reach consensus in selecting the final questions.
At the end of the study, an in-depth interview will take place with a predefined topic list.
Measured: For a minimum of 12 weeks
Secondary outcomes (6)
User characteristics of the application.
Data will be collected from logs, available in the back office of the application
Measured: for a minimum of 12 weeks
Possible change,impact on personal clinical parameters: HbA1c
HbA1c will be expressed in %
Measured: for a minimum of 12 weeks
Possible change,impact on personal clinical parameters: blood pressure
Both systolic and diastolic blood pressure will be measured, expressed in mmHg.
Measured: For a minimum of 12 weeks
Possible change,impact on personal clinical parameters: glycemia
Glycemia will be expressed in mg/dl.
Measured: For a minimum of 12 weeks
Possible change,impact on personal clinical parameters: girth
Girth will be expressed in cm.
Measured: For a minimum of 12 weeks
Possible change,impact on personal clinical parameters: bodyweight
Weight will be expressed in kg.
Measured: For a minimum of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start1 Oct 2021
- Primary completion28 Feb 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The patient population in this pilot study consists of two cohorts. All inclusions start from the GP, based on well-defined inclusion criteria. The reason for working with two parallel cohorts is based on the premise that different patient characteristics will confound the results and provide a distorted conclusion if not separated. One group is anticipated to consist of patients capable of using the application independently, while the other group is expected to have patients that will likely be more dependent on others for help with digital applications. This discrepancy could impact the usability and evaluation of the application. Literature shows that in similar pilot studies numbers of participants can vary a lot. Taking into regard the inclusion criteria, labor intensity and limited resources of this study investigators aim to include 15-30 patients for cohort 1 and 5-15 patients for cohort 2.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wit-Gele Kruis Limburg, KLAV, Ferm Thuiszorg, I-mens, Vlaams Patiëntenplatform, Wit-Gele Kruis Vlaanderen, POM Limburg
- Responsible party
- Sponsor
- Investigators
- Yves Breysem, Dr, Principal investigator, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226182
- Sponsor's protocol ID
- 2021/036
- Status last verified
- Jan 2022
- First submitted
- 27 Oct 2021
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualisation of a Digital Care Pathway in Limburg, in Context of Digital Care Support as a Stepping Stone for Flanders.
- ClinicalTrials.gov ID
- NCT05226182
- Acronym / sponsor ID
- 2021/036
- Conditions
- Type 2 Diabetes, Multidisciplinary Communication, Empowerment, Patient Empowerment, Patient Acceptance of Health Care
- Keywords
- digital, care, pathway, type 2, Diabetes, visualization, E-health, pilot study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Collaborators
- Wit-Gele Kruis Limburg, KLAV, Ferm Thuiszorg, I-mens, Vlaams Patiëntenplatform, Wit-Gele Kruis Vlaanderen, POM Limburg
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 7 Feb 2022 (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.
As part of the EFRO (Europees Fonds Regionale Ontwikkeling) 1302 project "Digital Care Support in Practice with Limburg as a Stepping Stone for Flanders", this study aims to evaluate the concept and added value of visualising a personal digital care pathway for patients with type 2 diabetes. Firstly, this chronological visualisation of data strives to improve patient experience and empowerment by offering educational articles and personal medical data relevant to their care path in one place. This way, patients will have more insight in the pathogenesis, treatments, complications and goals, allowing the patients to optimize their selfcare and become confident in dealing with their chronic condition. From time to time, patients will also be asked to complete questionnaires concerning their experiences (PREM) to aid healthcare professionals in personalizing treatment goals. Secondly, the healthcare providers and caregivers surrounding the patient will also have access to the same data, allowing for a more personal approach as well as means to communicate with other members of the care team.
Detailed description
Good quality of care requires a multidisciplinary approach, especially with chronic illnesses. Therefore, all members of the care team should be adequately informed and communicate well with each other. Additionally, patients should have a key role in their treatment plan. To successfully optimize self care, patients have to be well-informed about pathogenesis, treatments and complications so that expectations are realistic and attainable goals can be set. Currently, access to this relevant data is fragmented and often unavailable.
The newly developed application creates a central platform where all relevant data, educational material, medication scheme... are available for both the patient and healthcare professionals. The targeted study population are patients with type 2 diabetes who will be recruited by their general practitioner (GP) over a period of 3 months. When patients are interested in partaking, they will be contacted by a healthcare professional who will function as a Single Point of Contact (SPOC) for the patient during the entirety of the study with a maximum duration of 6 months. The SPOC helps with the start up of the application, collects administrative data and contacts the participants at regular intervals to help with difficulties in using the application. Furthermore, the SPOC will administer a questionnaire determining patient involvement and experience at the start and end of the study, as well as conduct an in-depth interview when the study is completed. Throughout the study, other questionnaires will be digitally available for the patient as part of the care path. These patient reported outcome and experience measures (PROM/PREM) will support healthcare professionals in providing a more integral care.
Consequently, involved healthcare professionals will also be contacted, informed and asked to complete a questionnaire once healthcare professionals agree to participate in the study. This questionnaire will focus on the information and communication needs between members of the care team and will also be repeated at the end, followed by an in-depth interview.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patient population in this pilot study consists of two cohorts. All inclusions start from the GP, based on well-defined inclusion criteria. The reason for working with two parallel cohorts is based on the premise that different patient characteristics will confound the results and provide a distorted conclusion if not separated. One group is anticipated to consist of patients capable of using the application independently, while the other group is expected to have patients that will likely be more dependent on others for help with digital applications. This discrepancy could impact the usability and evaluation of the application. Literature shows that in similar pilot studies numbers of participants can vary a lot. Taking into regard the inclusion criteria, labor intensity and limited resources of this study investigators aim to include 15-30 patients for cohort 1 and 5-15 patients for cohort 2.
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Other: visualisation of a digital care pathImplementation and visualisation of digital care path. Pre measurement: questionnaire quantifying patient involvement and experience on a 5-p Likert scale. Post measurement: questionnaire quantifying patient involvement and experience on a 5-p Likert scale, questionnaire quantifying usability of the tool and in-depth interview. |
| healthcare professionals | Experimental | Other: visualisation of a digital care pathImplementation and visualisation of digital care path. Pre measurement: questionnaire quantifying communication needs and experiences on a 5-p Likert scale. Post measurement: questionnaire quantifying communication needs and experiences on a 5-p Likert scale, questionnaire quantifying usability of the tool and in-depth interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patients with type 2 diabetes (voortraject and zorgtraject)
- independent and mentally competent
- digitally literate and in possession of an email address
- mastered the Dutch language
- able to visit the GP (no house calls)
Key exclusion criteria (4 listed)
- patients type 2 Diabetes enrolled in the Diabetes convention
- pregnant patients
- illiterate people
- patients living in a residential care center
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 |
|---|---|---|
| visualisation of a digital care pathThe implementation and visualisation of a digital care path, specifically designed for patients with type 2 diabetes and their care team. The digital care path wil include: 1) a timeline with appointments, messages and questionnaires 2) Diabetes related articles 3) a page for monitoring clinical parameters and goals 4) a section displaying information on their care team and personal health records. The aim of this intervention is to evaluate whether providing a central platform for all data will increase patient empowerment and involvement. Secondly it will also evaluate whether the communication between healthcare professionals improves when selected data is readily available for the entire care team. | Other | healthcare professionals, patients |
Primary outcome
Change in patient empowerment and involvement
Time frame: For a minimum of 12 weeks
Primary outcome measures will be determined with the aid of a questionnaire scoring answers on a 5p-Likert scale. Due to limited availability of validated questionnaires in Dutch, a custom set of questions was generated. Starting from validated English questionnaires on each topic, the Delphi method was used to reach consensus in selecting the final questions. At the end of the study, an in-depth interview will take place with a predefined topic list.
Change in care team communication and sharing of data
Time frame: For a minimum of 12 weeks
Primary outcome measures will be determined with the aid of a questionnaire scoring answers on a 5p-Likert scale. Due to limited availability of validated questionnaires in Dutch, a custom set of questions was generated. Starting from validated English questionnaires on each topic, the Delphi method was used to reach consensus in selecting the final questions. At the end of the study, an in-depth interview will take place with a predefined topic list.
Usability and acceptance of the application in patients and healthcare professionals
Time frame: For a minimum of 12 weeks
Primary outcome measures will be determined with the aid of a questionnaire scoring answers on a 5p-Likert scale. Due to limited availability of validated questionnaires in Dutch, a custom set of questions was generated. Starting from validated English questionnaires on each topic, the Delphi method was used to reach consensus in selecting the final questions. At the end of the study, an in-depth interview will take place with a predefined topic list.
6 secondary outcomes
User characteristics of the application.
Time frame: for a minimum of 12 weeks
Possible change,impact on personal clinical parameters: HbA1c
Time frame: for a minimum of 12 weeks
Possible change,impact on personal clinical parameters: blood pressure
Time frame: For a minimum of 12 weeks
Possible change,impact on personal clinical parameters: glycemia
Time frame: For a minimum of 12 weeks
Possible change,impact on personal clinical parameters: girth
Time frame: For a minimum of 12 weeks
Possible change,impact on personal clinical parameters: bodyweight
Time frame: For a minimum of 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Yves Breysem, Dr principal investigator
Jessa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visualisation of a digital care path in people with Type 2 Diabetes and Multidisciplinary Communication, run by Jessa Hospital at 1 site in Belgium.
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 8 inclusion and 4 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 24 Feb 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 Belgium. 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?
Contact Emilie Weyens (+32 11 33 51 17, emilie.weyens@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient empowerment and involvement (time frame: For a minimum of 12 weeks). The study lists 3 primary outcomes in all. 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 24 Feb 2022.