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Visualisation of a Digital Care Pathway.

7. februar 2022 oppdatert av: Jessa Hospital

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

45

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Eksperimentell: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in patient empowerment and involvement
Tidsramme: 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.
For a minimum of 12 weeks
Change in care team communication and sharing of data
Tidsramme: 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.
For a minimum of 12 weeks
Usability and acceptance of the application in patients and healthcare professionals
Tidsramme: 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.
For a minimum of 12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
User characteristics of the application.
Tidsramme: for a minimum of 12 weeks
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
Tidsramme: for a minimum of 12 weeks
HbA1c will be expressed in %
for a minimum of 12 weeks
Possible change,impact on personal clinical parameters: blood pressure
Tidsramme: For a minimum of 12 weeks
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
Tidsramme: For a minimum of 12 weeks
Glycemia will be expressed in mg/dl.
For a minimum of 12 weeks
Possible change,impact on personal clinical parameters: girth
Tidsramme: For a minimum of 12 weeks
Girth will be expressed in cm.
For a minimum of 12 weeks
Possible change,impact on personal clinical parameters: bodyweight
Tidsramme: For a minimum of 12 weeks
Weight will be expressed in kg.
For a minimum of 12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Jessa Hospital

Samarbeidspartnere

Wit-Gele Kruis Limburg
KLAV
Ferm Thuiszorg
I-mens
Vlaams Patiëntenplatform
Wit-Gele Kruis Vlaanderen
POM Limburg

Etterforskere

  • Hovedetterforsker: Yves Breysem, Dr, Jessa Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. oktober 2021

Primær fullføring (Forventet)

28. februar 2022

Studiet fullført (Forventet)

30. juni 2022

Datoer for studieregistrering

Først innsendt

27. oktober 2021

Først innsendt som oppfylte QC-kriteriene

25. januar 2022

Først lagt ut (Faktiske)

7. februar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. februar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. februar 2022

Sist bekreftet

1. januar 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 2021/036

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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