- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Emilie Weyens
- Numéro de téléphone: +32 11 33 51 17
- E-mail: emilie.weyens@jessazh.be
Sauvegarde des contacts de l'étude
- Nom: Jolien Nelissen, Dr
- Numéro de téléphone: +32 11 33 51 18
- E-mail: jolien.nelissen@jessazh.be
Lieux d'étude
-
-
Limburg
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Hasselt, Limburg, Belgique, 3500
- Recrutement
- Jessa Hospital
-
Contact:
- Emilie Weyens
- E-mail: emilie.weyens@jessazh.be
-
Contact:
- Jolien Nelissen, Dr.
- E-mail: jolien.nelissen@jessazh.be
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in patient empowerment and involvement
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
User characteristics of the application.
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: For a minimum of 12 weeks
|
Weight will be expressed in kg.
|
For a minimum of 12 weeks
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Yves Breysem, Dr, Jessa Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2021/036
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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