NCT05692778Recruiting
Optimized Care of People With Diabetes and Foot Complication in Primary Care
Source: ClinicalTrials.gov · Last updated 17 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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?
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 140 (estimated)
- First submitted
- 7 Jan 2023
- Start date
- 1 Jan 2020
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Sahlgrenska University Hospital
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05692778
What you commit to
- Study type: Observational
- Planned participants: 140
- From 1 Jan 2020 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Not understand spoken and written Swedish
Who the study is looking for
- Persons with diabetes being treated in Region Västra Götaland
- Understand spoken and written Swedish
- Professionals working with patients with diabetes having foot complications.
- Working in Region Västra Götaland
- Understand spoken and written Swedish
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Departmetn of Prosthetics & Orthotics, Sahlgrenska University Hospital Coordinator of this site? Confirm its status | Gothenburg | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.