Clinical trial NCT05692778: Optimized Care of People With Diabetes and Foot Complication in Primary Care
Official title: Optimized Care of People With Diabetes and Foot Complication in Primary Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Diabetic Foot
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetes Complications
Keywords: diabetes
diabetic foot
eHealth
foot deformities
prevention
co-design
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2023-01-20
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Patients living in Region Västra Götaland being treated in a care unit in the same region.

Professionals Professionalsm working in Region Västra Götaland being treating patientes in a care unit in the same region.

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?

Detailed description: 1. Method - Validation

   Below is a description of the method used to answer the research questions:

   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? An interdisciplinary expert group will validate, in a series of meetings, what items to include in a structured foot assessment, called "D-Foot CARE" aimed to assess the risk to develop diabetic foot ulcers. Procedures, how to make the specific foot assessments in "D-Foot CARE" will be developed. The content in "D-Foot CARE" will be based on scientific literature, clinical guidelines and recommendation. The validation process is documented by the principal investigator.
2. Method - Mapping

Below is a description of the method used to answer the research questions:

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?

   Patients with diabetes and healthcare professionals' answers questionnaires, digital or in paper format, according to the method called Concept Mapping, a method used in action research. By using Concept mapping a variety of points of views are gathered when respondents answers an open question. Following the instructions in the survey the respondents complete a sentence. An example: "The national board of health and welfare recommends that persons with diabetes should have their feet foot checked annually. The aim is to promote good foot health. Persons with diabetes, at risk, should be treated with podiatry and be referred to the department of prosthetics \& orthotics. Here, below, is an open question that you complete with your own words To improve care and self-care of the feet for persons with diabetes I suggest that....

   Information about the study is available for persons with diabetes in different ways:
   1. Through advertisement; information by the patient's organization; through primary care centers in Skaraborg and by the department of prosthetics \& orthotics.
   2. At meetings arranged by the patient's organization
   3. At the primary care center Information about the study for health care professionals working with patients with diabetes having foot complications is given from the research team.

   3. Method - interview how it is to use a paper format supporting a structured foot assessment By semi-structured interviews with healthcare professionals,, that have used a structured paper format as support when they made foot examination in patients with diabetes, their experiences of working with the paper format was evaluated.

   4. Interviews - footwear By telephone semi- structured interviews with persons with diabetes factors that influence their choice of footwear is investigated.

   5. Interviews - usability test of using an eHealth tool In usability tests the use of eHealth tools supporting care and self-care of the feet is evaluated.

   6. Experiences of using an eHealth tool supporting the foot assessment Patients with diabetes and healthcare professionals report their experiences of using eHealth tool by filling in survey, e.g. the System Usability Scale.

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

a. Patients that visits care fills in 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 By using the NASSS CAT framework: Non-adoption, Abandonment, Scale-up, Spread, and Sustainability of health technology; CAT: complexity assessment tool) complexities are explored and managed in the development, test, management, spread and sustain of the eHealth tool.

9. Long term effect

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

The Researchers will compare long-term outcomes from the intervention group with a comparison group consisting of medical record data of patients from a couple of primary care centers for following parameters:

2. number of patients that have had an annual foot examination 3. number of patient that had had a digital annual foot examination 4. number of patients that have a diabetic foot ulcer 5. number of patients that hat an amputation in the lower extremities 6. risk grad 7. have had podiatry 8. location for foot care (at home, mobile team)

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

Primary outcomes:
measure: Validation
timeFrame: 2020-2021
measure: Mapping
timeFrame: 2020-2023
measure: Interviews - to use a paper format supporting a structured foot assessment
timeFrame: 2020-2023
measure: Interviews - footwear
timeFrame: 2023-2025
measure: Interviews - usability test of using an eHealth tool
timeFrame: 2020-2024
measure: Experiences of using an eHealth tool supporting the foot assessment
timeFrame: 2020-2024
Secondary outcomes:
measure: Questionnaires regarding self-perceived quality of life, the experiences of the visit at the care unit, transportation to the care unit.
timeFrame: 2020-2025
measure: Critical evaluation of complexity
timeFrame: 2020-2025
measure: Long term effect
timeFrame: 2023-2028
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Departmetn of Prosthetics & Orthotics, Sahlgrenska University Hospital
Study officials:
References: