- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05226182
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Emilie Weyens
- Telefonní číslo: +32 11 33 51 17
- E-mail: emilie.weyens@jessazh.be
Studijní záloha kontaktů
- Jméno: Jolien Nelissen, Dr
- Telefonní číslo: +32 11 33 51 18
- E-mail: jolien.nelissen@jessazh.be
Studijní místa
-
-
Limburg
-
Hasselt, Limburg, Belgie, 3500
- Nábor
- Jessa Hospital
-
Kontakt:
- Emilie Weyens
- E-mail: emilie.weyens@jessazh.be
-
Kontakt:
- Jolien Nelissen, Dr.
- E-mail: jolien.nelissen@jessazh.be
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Nerandomizované
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in patient empowerment and involvement
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
User characteristics of the application.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: For a minimum of 12 weeks
|
Weight will be expressed in kg.
|
For a minimum of 12 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Yves Breysem, Dr, Jessa Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2021/036
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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