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RECRUITING
NCT05692778

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

Sponsor: Sahlgrenska University Hospital

View on ClinicalTrials.gov

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?

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

140

Start Date

2020-01-01

Completion Date

2026-12-31

Last Updated

2024-04-17

Healthy Volunteers

No

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

Locations (1)

Departmetn of Prosthetics & Orthotics, Sahlgrenska University Hospital

Gothenburg, Sweden