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.

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Patient Empowerment; Patient Acceptance of Health Care; Multidisciplinary Communication; Empowerment
• Intervention / Treatment: Other: visualisation of a digital care path

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emilie Weyens; Phone Number: +32 11 33 51 17; Email: emilie.weyens@jessazh.be
• Study Contact Backup: Name: Jolien Nelissen, Dr; Phone Number: +32 11 33 51 18; Email: jolien.nelissen@jessazh.be

Study Locations

• Belgium
  • Limburg
    • Hasselt, Limburg, Belgium, 3500
      • Recruiting
      • Jessa Hospital
      • Contact: Emilie Weyens; Email: emilie.weyens@jessazh.be
      • Contact: Jolien Nelissen, Dr.; Email: jolien.nelissen@jessazh.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Possible change,impact on personal clinical parameters: HbA1c	HbA1c will be expressed in %	for a minimum of 12 weeks
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
Possible change,impact on personal clinical parameters: glycemia	Glycemia will be expressed in mg/dl.	For a minimum of 12 weeks
Possible change,impact on personal clinical parameters: girth	Girth will be expressed in cm.	For a minimum of 12 weeks
Possible change,impact on personal clinical parameters: bodyweight	Weight will be expressed in kg.	For a minimum of 12 weeks

Collaborators and Investigators

• Sponsor: Jessa Hospital
• Collaborators: Wit-Gele Kruis Limburg; KLAV; Ferm Thuiszorg; I-mens; Vlaams Patiëntenplatform; Wit-Gele Kruis Vlaanderen; POM Limburg
• Investigators: Principal Investigator: Yves Breysem, Dr, Jessa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes; pilot study; E-health; care; type 2; digital; pathway; visualization; visualisation
• Other Study ID Numbers: 2021/036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No