NCT05692778 Optimized Care of People With Diabetes and Foot Complication in Primary Care
| NCT ID | NCT05692778 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sahlgrenska University Hospital |
| Condition | Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2020-01-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2020-01-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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?
Eligibility Criteria
Inclusion Criteria patients: * Persons with diabetes being treated in Region Västra Götaland * Understand spoken and written Swedish Exclusion Criteria: • Not understand spoken and written Swedish Inclusion Criteria healthcare professionals: * Professionals working with patients with diabetes having foot complications. * Working in Region Västra Götaland * Understand spoken and written Swedish
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05692778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05692778 currently recruiting?
Yes, NCT05692778 is actively recruiting participants. Contact the research team at ulla.tang@vgregion.se for enrollment information.
Where is the NCT05692778 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT05692778 clinical trial?
NCT05692778 is sponsored by Sahlgrenska University Hospital. The trial plans to enroll 140 participants.
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