Visualisation of a Digital Care Pathway.
Visualisation of a Digital Care Pathway in Limburg, in Context of Digital Care Support as a Stepping Stone for Flanders.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Emilie Weyens
- Telefoonnummer: +32 11 33 51 17
- E-mail: emilie.weyens@jessazh.be
Studie Contact Back-up
- Naam: Jolien Nelissen, Dr
- Telefoonnummer: +32 11 33 51 18
- E-mail: jolien.nelissen@jessazh.be
Studie Locaties
-
-
Limburg
-
Hasselt, Limburg, België, 3500
- Werving
- Jessa Hospital
-
Contact:
- Emilie Weyens
- E-mail: emilie.weyens@jessazh.be
-
Contact:
- Jolien Nelissen, Dr.
- E-mail: jolien.nelissen@jessazh.be
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria for cohort 1 and 2:
- 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
Exclusion Criteria:
- patients type 2 Diabetes enrolled in the Diabetes convention
- pregnant patients
- illiterate people
- patients living in a residential care center
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: patients
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. |
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.
|
|
Experimenteel: healthcare professionals
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. |
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in patient empowerment and involvement
Tijdsspanne: 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. |
For a minimum of 12 weeks
|
|
Change in care team communication and sharing of data
Tijdsspanne: 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. |
For a minimum of 12 weeks
|
|
Usability and acceptance of the application in patients and healthcare professionals
Tijdsspanne: 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. |
For a minimum of 12 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
User characteristics of the application.
Tijdsspanne: for a minimum of 12 weeks
|
Data will be collected from logs, available in the back office of the application
|
for a minimum of 12 weeks
|
|
Possible change,impact on personal clinical parameters: HbA1c
Tijdsspanne: for a minimum of 12 weeks
|
HbA1c will be expressed in %
|
for a minimum of 12 weeks
|
|
Possible change,impact on personal clinical parameters: blood pressure
Tijdsspanne: For a minimum of 12 weeks
|
Both systolic and diastolic blood pressure will be measured, expressed in mmHg.
|
For a minimum of 12 weeks
|
|
Possible change,impact on personal clinical parameters: glycemia
Tijdsspanne: For a minimum of 12 weeks
|
Glycemia will be expressed in mg/dl.
|
For a minimum of 12 weeks
|
|
Possible change,impact on personal clinical parameters: girth
Tijdsspanne: For a minimum of 12 weeks
|
Girth will be expressed in cm.
|
For a minimum of 12 weeks
|
|
Possible change,impact on personal clinical parameters: bodyweight
Tijdsspanne: For a minimum of 12 weeks
|
Weight will be expressed in kg.
|
For a minimum of 12 weeks
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Yves Breysem, Dr, Jessa Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 2021/036
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .