Clinical trial NCT05226182: Visualisation of a Digital Care Pathway.
Official title: Visualisation of a Digital Care Pathway in Limburg, in Context of Digital Care Support as a Stepping Stone for Flanders.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Multidisciplinary Communication
Empowerment
Patient Empowerment
Patient Acceptance of Health Care
Keywords: digital
care
pathway
type 2
Diabetes
visualization
E-health
pilot study
visualisation
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
Collaborators: name: Wit-Gele Kruis Limburg
name: KLAV
name: Ferm Thuiszorg
name: I-mens
name: Vlaams Patiëntenplatform
name: Wit-Gele Kruis Vlaanderen
name: POM Limburg
First posted: 2022-02-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The patient population in this pilot study consists of two cohorts. All inclusions start from the GP, based on well-defined inclusion criteria. The reason for working with two parallel cohorts is based on the premise that different patient characteristics will confound the results and provide a distorted conclusion if not separated. One group is anticipated to consist of patients capable of using the application independently, while the other group is expected to have patients that will likely be more dependent on others for help with digital applications. This discrepancy could impact the usability and evaluation of the application.

Literature shows that in similar pilot studies numbers of participants can vary a lot. Taking into regard the inclusion criteria, labor intensity and limited resources of this study investigators aim to include 15-30 patients for cohort 1 and 5-15 patients for cohort 2.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in patient empowerment and involvement
timeFrame: For a minimum of 12 weeks
measure: Change in care team communication and sharing of data
timeFrame: For a minimum of 12 weeks
measure: Usability and acceptance of the application in patients and healthcare professionals
timeFrame: For a minimum of 12 weeks
Secondary outcomes:
measure: User characteristics of the application.
timeFrame: for a minimum of 12 weeks
measure: Possible change,impact on personal clinical parameters: HbA1c
timeFrame: for a minimum of 12 weeks
measure: Possible change,impact on personal clinical parameters: blood pressure
timeFrame: For a minimum of 12 weeks
measure: Possible change,impact on personal clinical parameters: glycemia
timeFrame: For a minimum of 12 weeks
measure: Possible change,impact on personal clinical parameters: girth
timeFrame: For a minimum of 12 weeks
measure: Possible change,impact on personal clinical parameters: bodyweight
timeFrame: For a minimum of 12 weeks
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Jessa Hospital
name: Yves Breysem, Dr
role: PRINCIPAL_INVESTIGATOR
References: