Visualisation of a Digital Care Pathway.

Type 2 Diabetes Clinical Trial

Official title:

Visualisation of a Digital Care Pathway in Limburg, in Context of Digital Care Support as a Stepping Stone for Flanders.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05226182
• Other study ID #: 2021/036
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: January 2022
• Source: Jessa Hospital
• Contact: Emilie Weyens
• Phone: +32 11 33 51 17
• Email: emilie.weyens[@]jessazh.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 30, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Empowerment
• Multidisciplinary Communication
• Patient Acceptance of Health Care
• Patient Empowerment
• Type 2 Diabetes

Intervention

Other:
• visualisation of a digital care path
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.

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (8)

Lead Sponsor	Collaborator
Jessa Hospital	Ferm Thuiszorg, I-mens, KLAV, POM Limburg, Vlaams Patiëntenplatform, Wit-Gele Kruis Limburg, Wit-Gele Kruis Vlaanderen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	For a minimum of 12 weeks
Primary	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.	For a minimum of 12 weeks
Primary	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.	For a minimum of 12 weeks
Secondary	User characteristics of the application.	Data will be collected from logs, available in the back office of the application	for a minimum of 12 weeks
Secondary	Possible change,impact on personal clinical parameters: HbA1c	HbA1c will be expressed in %	for a minimum of 12 weeks
Secondary	Possible change,impact on personal clinical parameters: blood pressure	Both systolic and diastolic blood pressure will be measured, expressed in mmHg.	For a minimum of 12 weeks
Secondary	Possible change,impact on personal clinical parameters: glycemia	Glycemia will be expressed in mg/dl.	For a minimum of 12 weeks
Secondary	Possible change,impact on personal clinical parameters: girth	Girth will be expressed in cm.	For a minimum of 12 weeks
Secondary	Possible change,impact on personal clinical parameters: bodyweight	Weight will be expressed in kg.	For a minimum of 12 weeks