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

NCT05692778 | Recruiting

• 1 other identifier: Dnr 2020-02175
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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. 1.Validation
2. 2.Mapping
3. 3.How do health care professionals and patients with diabetes experience that the future foot examination should be designed?
4. 4.What experiences have health care professionals and patients with diabetes to use an eHealth tool supporting the annual foot examination?
5. 5.Interviews - to use a paper format supporting a structured foot assessment
6. 6.Interviews - footwear
7. 7.Interviews - usability test of using an eHealth tool
8. 8.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.
9. 9.How could a digital eHealth solution be implemented, managed and spread in public health care setting?

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

Outcome Measures

Primary Outcomes (6)

• Validation

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

  2020-2021

• 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.

  2020-2023

• 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.

  2020-2023

• 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.

  2023-2025

• Interviews - usability test of using an eHealth tool

  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).

  2020-2024

• Experiences of using an eHealth tool supporting the foot assessment

  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

  2020-2024

Secondary Outcomes (3)

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

  2020-2025

• Critical evaluation of complexity

  2020-2025

• Long term effect

  2023-2028

Study Arms (2)

1: Patients being foot examined by using an eHealth tool

Patients being foot examined by using an eHealth tool

Other: Patients being foot examined by using an eHealth tool

2: Patients being foot examined in traditional manner

Patients being foot examined in traditional manner

Other: Patients being foot examined in traditional manner

Interventions

Patients being foot examined by using an eHealth tool OTHER

Patients being foot examined by using an eHealth tool that has been developed, will be tested with the intention to implement the eHealth tool

1: Patients being foot examined by using an eHealth tool

Patients being foot examined in traditional manner OTHER

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

2: Patients being foot examined in traditional manner

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Persons with diabetes being treated in Region Västra Götaland
• Understand spoken and written Swedish

You may not qualify if:

• Not understand spoken and written Swedish
• Professionals working with patients with diabetes having foot complications.
• Working in Region Västra Götaland
• Understand spoken and written Swedish

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

Departmetn of Prosthetics & Orthotics, Sahlgrenska University Hospital

Gothenburg, 41285, Sweden

RECRUITING

Related Publications (2)

• Hellstrand Tang U, Scandurra I, Sundberg L, Annersten Gershater M, Zugner R. Patients' Expectations of Evidence-Based Service at the Pharmacy Regarding Information on Self-Care of the Feet for Persons with Diabetes at Risk of Developing Foot Ulcers - A Cross-Sectional Observational Study in Sweden. Patient Prefer Adherence. 2023 Dec 27;17:3557-3576. doi: 10.2147/PPA.S435632. eCollection 2023.

  PMID: 38169667 DERIVED

• Andersson S, Scandurra I, Nystrom U, Varemo M, Hellstrand Tang U. Experiences of a Novel Structured Foot Examination Form for Patients With Diabetes From the Perspective of Health Care Professionals: Qualitative Study. JMIR Nurs. 2023 Jul 18;6:e45501. doi: 10.2196/45501.

  PMID: 37463012 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Foot; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Diabetes Complications; Foot Deformities

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Neuropathies; Autoimmune Diseases; Immune System Diseases; Musculoskeletal Diseases

Central Study Contacts

Ulla Hellstrand Tang, PhD

CONTACT

0046706397913; ulla.tang@vgregion.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2023
• First Posted: January 20, 2023
• Study Start: January 1, 2020
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

SE (1)