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.
NCT number | NCT05226182 |
Other study ID # | 2021/036 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 1, 2021 |
Est. completion date | June 30, 2022 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Jessa Hospital | Hasselt | Limburg |
Lead Sponsor | Collaborator |
---|---|
Jessa Hospital | Ferm Thuiszorg, I-mens, KLAV, POM Limburg, Vlaams Patiëntenplatform, Wit-Gele Kruis Limburg, Wit-Gele Kruis Vlaanderen |
Belgium,
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 |
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