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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

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?

Eligibility

Primary outcome measure(s)

• Validation — 2020-2021
  A valid foot examination routine is developed and presented in paper format.
• Mapping — 2020-2023
  A variety of points of views are gathered regarding how the future foot care process should be managed. The method used Concept Mapping, is a methodology for mapping ideas that integrates input from multiple sources with differing expertise or interest, creates maps with multivariate data analyses that depict the composite thinking of the group, and yields data that allows for comparisons across rating criteria, stakeholder groups, different points in time, etc. to aid in targeted planning, implementation strategies, and evaluation. Group concept mapping is related to the growing interest in the role that theory plays in planning and evaluation.
• Interviews - to use a paper format supporting a structured foot assessment — 2020-2023
  Experiences regarding how do health care professionals experienced it to use a structured foot form, in paper form will be gathered using qualitative content analysis, as described by Graneheim and Lundman, is considered appropriate in order inductively to focus on and describe experiences and variations on an individual level and to identify differences and similarities on a manifest and latent level. The analysis will be conducted in several steps. First, all the data will be read several times to ensure immersion in the data. All interview text will be regarded as a unit of analysis. The text will then be divided into "meaning units" that corresponded to the aim of the study. Each meaning unit will be condensed and labelled with a code. Codes are described as concrete and as close to the text as possible. Semi-structured interviews will be held with two focus groups and individual interviews.
• Interviews - footwear — 2023-2025
  Factors are summarized regarding how patients with diabetes choose their footwear will be gathered using qualitative content analysis, as described by Graneheim and Lundman, is considered appropriate in order inductively to focus on and describe experiences and variations on an individual level and to identify differences and similarities on a manifest and latent level. The analysis will be conducted in several steps. First, all the data will be read several times to ensure immersion in the data. All interview text will be regarded as a unit of analysis. The text will then be divided into "meaning units" that corresponded to the aim of the study. Each meaning unit will be condensed and labelled with a code. Codes are described as concrete and as close to the text as possible. Semi-structured interviews will be held with two focus groups or individual interviews.
• Interviews - usability test of using an eHealth tool — 2020-2024
  The usability lab test is usually performed in three stages: preparation/planning, actual test and follow-up . After preparation the test will be performed, in three phases: the pre-test phase, the actual test and the post-test phase. The participants will follow the tasks assigned to the test and will be encouraged to think aloud while performing the test to gather more substantial and qualitative data. After the test, the users will be debriefed, preferably using both questionnaires and interviews. In the follow-up stage, the recordings are coded and collected data are analyzed. Specific problems found are analyzed in detail and results will be reported. System Usability Scale, a test used to gather test participants' expectations/experiences when the usability test will be used (0-100 scale).
• Experiences of using an eHealth tool supporting the foot assessment — 2020-2024
  Users, will reported how they expected and perceived it to use an eHealth tool supporting the foot examination evaluated with System Usability Scale (SUS). SUS is a test used to gather test participants' expectations/experiences when the usability test will be used (0-100 scale

Trial sites (1)

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