Optimized Care of People With Diabetes and Foot Complication in Primary Care

NCT05692778 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2024-04-17

No results posted yet for this study

Summary

The goal of this observational study is to create and evaluate and new management, by using eHealth tools, to prevent diabetic foot ulcers. The main questions it aims to answer are:

1. Validation

a. Is a method for foot assessment, that uses eHealth tools, valid regarding its usefulness? b. Is a method for foot assessment, that uses eHealth tools, reliable regarding the generated risk stratification?
2. Mapping

1. How do health care professionals and patients with diabetes experience that the future foot examination should be designed?
2. What experiences have health care professionals and patients with diabetes to use an eHealth tool supporting the annual foot examination?
3. Interviews - to use a paper format supporting a structured foot assessment

a. How do health care professionals experience to use a structured foot form, in paper form?
4. Interviews - footwear

a. What factors that influence how patients with diabetes choose their footwear?
5. Interviews - usability test of using an eHealth tool

a. How could a digital eHealth tool be designed? b. How could a digital eHealth solution be implemented, managed and spread in public health care setting? i. Participants will:

1\. fill in questionnaires 2. be interviewed 3. test eHealth solutions supporting the foot examination

6\. Experiences of using an eHealth tool supporting the foot assessment

a. How could a digital eHealth tool be designed?

7\. Questionnaires regarding self-perceived quality of life, the experiences of the visit at the care unit, transportation to the care unit.

a. Patients that visits care fills in a questionnaire regarding self-perceived quality of life (EQ-5D), a modified version of National Patient Survey, the diabetes questionnaire and a questionnaire regarding their travels and time for travels to and from the visit to the care unit.

8\. Critical evaluation of complexity

1. Exists complexity in the development, test, management, spread and sustain of an eHealth tool supporting foot examination and self-care of the feet in diabetes.
2. How could a digital eHealth solution be implemented, managed and spread in public health care setting?

9\. Long term effect

a. What is the long-term effect of using an eHealth tools supporting a structured foot examination?

Conditions

Interventions

OTHER

Patients being foot examined by using an eHealth tool

Patients being foot examined by using an eHealth tool that has been developed, will be tested with the intention to implement the eHealth tool

OTHER

Patients being foot examined in traditional manner

Patient are being foot examined in the way as health care professionals usually make the foot examination in patients with diabetes

Sponsors & Collaborators

  • Vastra Gotaland Region

    collaborator OTHER_GOV
  • Sahlgrenska University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2024-12-31
Completion
2026-12-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05692778 on ClinicalTrials.gov