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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Persons with diabetes being treated in Region Västra Götaland

Understand spoken and written Swedish

Disqualifiers

Professionals working with patients with diabetes having foot complications.

Working in Region Västra Götaland

Understand spoken and written Swedish

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Patients being foot examined by using an eHealth tool

    Other intervention

    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

    Other intervention

    Patient are being foot examined in the way as health care professionals usually make the foot examination in patients with diabetes

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: 1: Patients being foot examined by using an eHealth tool1 intervention
Group B: 2: Patients being foot examined in traditional manner1 intervention

Trial outcomes

Primary outcomes

1

Validation

A valid foot examination routine is developed and presented in paper format.

Time frame
2020-2021
2

Mapping

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.

Time frame
2020-2023
3

Interviews - to use a paper format supporting a structured foot assessment

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.

Time frame
2020-2023
4

Interviews - footwear

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.

Time frame
2023-2025

Secondary outcomes

1

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

Summaries regarding self-perceived quality of life, the experiences of the visit at the care unit, transportation to the care unit are made. Self-perceived quality of life is measured with EQ-5D, a standardised, reliable and valid measurement of health status developed by the EuroQol Group in order to provide a simple, generic measurement of health for clinical and economic appraisal. The answers kan be levelled in: 1) I have no problems…, level 2) I have slight problems…, 3) I have moderate problems…,4) I have severe problems…,5) I am unable to… Experiences of the visit at the care unit will be measured with a modified version of the national Swedish patient survey. Transportation to the care unit will be registered in km and hour/minutes

Time frame
2020-2025
2

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.

Time frame
2020-2025
3

Long term effect

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, measured in numbers of patients that: 2\. had an annual foot examination 3. had a digital annual foot examination 4. have a diabetic foot ulcer 5. had an amputation in the lower extremities 6. risk grad (1-4) 7. recieved podiatry and 8. location for foot care (at home, mobile team)

Time frame
2023-2028

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sahlgrenska University Hospital

Lead sponsor

Vastra Gotaland Region

Collaborator