Visualisation of a Digital Care Pathway.

NCT05226182 | Unknown

• 1 other identifier: 2021/036
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• User characteristics of the application.

  for a minimum of 12 weeks

• Possible change,impact on personal clinical parameters: HbA1c

  for a minimum of 12 weeks

• Possible change,impact on personal clinical parameters: blood pressure

  For a minimum of 12 weeks

• Possible change,impact on personal clinical parameters: glycemia

  For a minimum of 12 weeks

• Possible change,impact on personal clinical parameters: girth

  For a minimum of 12 weeks

Study Arms (2)

patients

EXPERIMENTAL

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

healthcare professionals

EXPERIMENTAL

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

Interventions

visualisation of a digital care path OTHER

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.

healthcare professionals; patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• presence of a home nurse in the context of the Diabetes care
• presence of a home care service

You may not qualify if:

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

Sponsors & Collaborators

• Jessa Hospital: lead
• Wit-Gele Kruis Limburg: collaborator
• KLAV: collaborator
• Ferm Thuiszorg: collaborator
• I-mens: collaborator
• Vlaams Patiëntenplatform: collaborator
• Wit-Gele Kruis Vlaanderen: collaborator
• POM Limburg: collaborator

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Empowerment; Patient Participation; Patient Acceptance of Health Care; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Social Behavior; Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Yves Breysem, Dr

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Weyens

CONTACT

+32 11 33 51 17; emilie.weyens@jessazh.be

Jolien Nelissen, Dr

CONTACT

+32 11 33 51 18; jolien.nelissen@jessazh.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: February 7, 2022
• Study Start: October 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: June 30, 2022
• Last Updated: February 24, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)