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Completed

NCT Number: NCT04244110

Pilot for the Analysis of Usability in the Use of the Diacare Platform for People With Type 2 DM and Their Professionals

The objective of this study is to evaluate the usability, utility and feasibility of the Diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CAP Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

About this study

Type 2 diabetes mellitus is a chronic disease that increases the risk of patients suffering from heart disease, embolisms and microvascular complications such as blindness, kidney failure and peripheral neuropathies. In order to achieve an optimum level of independence in their self care, it is essential that type 2 DM patients take responsibility for the situation and be actively involved in the control of their health. Technology can solve some of the current challenges of chronic diseases such as type 2 DM, and in fact there are studies that suggest that chronic diseases can be more manageable with the support of mHealth. In this context, the Diacare platform has been designed with the idea of improving the self-management and self-care of patients with type 2 DM in a more personalized and individual way. The Diacare platform consists of an application, a fitbit wristband for activity monitoring and a web platform for professionals. This research project wants to evaluate the usability, utility and feasibility of the Diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment. For this, a total of 35 patients and their respective health professionals will be recruited for the study and will use the DIACARE platform for 3 months. The results of this pilot will be collected through qualitative and quantitative data through the DIACARE platform and from questionnaires that will be administered to patients and professionals and will allow the evaluation of the technology developed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People diagnosed with type 2 DM based on clinical criteria
  • People who own a Smartphone and have competences in the use of technology

Exclusion criteria

  • People that cannot go to the primary care center
  • People with cognitive deterioration
  • People with limitations in the practice of physical exercise
  • People with a life expectancy lower than 6 months

Treatment and study plan

Primary outcomes

  1. Usability of the Diacare platform

    Time frame: 3 months

    System Usability Scale (SUS) is a self-administered questionnaire to evaluate the usability of the developed tool.

Sponsors and collaborators

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Other

Collaborators

  • Fundació TicSalut

Registry information

Official study title

Diacare Project: Pilot for the Analysis of Usability in the Use of the Diacare Project for People With DM2 and Their Professionals

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2020
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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