Visualisation of a Digital Care Pathway.

Not Applicable

• Conditions: Patient Acceptance of Health Care; Multidisciplinary Communication; Type 2 Diabetes; Patient Empowerment; Empowerment
• Interventions: Other: visualisation of a digital care path

• Registration Number: NCT05226182
• Lead Sponsor: Jessa Hospital

Brief 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.

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 Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2021-10-27
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-02-07
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-24
• Primary Completion: 2022-02-28
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

• patients type 2 Diabetes enrolled in the Diabetes convention
• pregnant patients
• illiterate people
• patients living in a residential care center

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients	visualisation of a digital care path	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.
healthcare professionals	visualisation of a digital care path	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.

Primary Outcome Measures

Name	Time	Method
Change in patient empowerment and involvement	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	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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium