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DiabetesNCT05692778

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

An observational study of Diabetes and Diabetic Foot, run by Sahlgrenska University Hospital at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Diabetic Foot, Diabetes Mellitus
What is being tested?
Patients being foot examined by using an eHealth tool and Patients being foot examined in traditional manner
How many people
140 participants
Where
1 siteSweden
Study dates
1 Jan 2020to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Persons with diabetes being treated in Region Västra Götaland
  • Understand spoken and written Swedish
  • Professionals working with patients with diabetes having foot complications.
  • Working in Region Västra Götaland
  • Understand spoken and written Swedish

Who cannot join

  • Not understand spoken and written Swedish

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ulla Hellstrand Tang, PhD contact

0046706397913

ulla.tang@vgregion.se

Sweden1 site, 1 recruiting

  • Departmetn of Prosthetics & Orthotics, Sahlgrenska University Hospital

    Gothenburg, 41285

    Ulla Hellstrand Tang, PhD, 0046706397913, ulla.tang@vgregion.se

    Recruiting

Other trials in Sweden

About this study

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
  2. 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?
  3. Mapping
  4. How do health care professionals and patients with diabetes experience that the future foot examination should be designed?
  5. What experiences have health care professionals and patients with diabetes to use an eHealth tool supporting the annual foot examination?
  6. Interviews - to use a paper format supporting a structured foot assessment
  7. How do health care professionals experience to use a structured foot form, in paper form?
  8. Interviews - footwear
  9. What factors that influence how patients with diabetes choose their footwear?
  10. Interviews - usability test of using an eHealth tool
  11. 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:
  12. fill in questionnaires 2. be interviewed 3. test eHealth solutions supporting the foot examination
  13. Experiences of using an eHealth tool supporting the foot assessment
  14. How could a digital eHealth tool be designed?
  15. Questionnaires regarding self-perceived quality of life, the experiences of the visit at the care unit, transportation to the care unit.
  16. 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.
  17. Critical evaluation of complexity
  18. 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.
  19. How could a digital eHealth solution be implemented, managed and spread in public health care setting?
  20. Long term effect
  21. What is the long-term effect of using an eHealth tools supporting a structured foot examination?
Read the detailed description
  1. Method - Validation Below is a description of the method used to answer the research questions:
  2. 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.
  3. 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:
  3. Through advertisement; information by the patient's organization; through primary care centers in Skaraborg and by the department of prosthetics \& orthotics.
  4. At meetings arranged by the patient's organization
  5. 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.
  6. 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.
  7. Interviews - footwear By telephone semi- structured interviews with persons with diabetes factors that influence their choice of footwear is investigated.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. Long term effect
  14. 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:

  1. 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)
Being tested
Patients being foot examined by using an eHealth tool, Patients being foot examined in traditional manner
Keywords
diabetes, diabetic foot, eHealth, foot deformities, prevention, co-design
Medical subject headings
Diabetes Mellitus, Diabetic Foot, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Diabetes Complications, Foot Deformities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patients being foot examined by using an eHealth toolOther

    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 mannerOther

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

Study groups in NCT05692778
Study groupRoleWhat they receive
1: Patients being foot examined by using an eHealth toolPatients being foot examined by using an eHealth tool
Receives: Other: Patients being foot examined by using an eHealth tool
2: Patients being foot examined in traditional mannerPatients being foot examined in traditional manner
Receives: Other: Patients being foot examined in traditional manner

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validation

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 2023-2025

  5. 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).

    Measured: 2020-2024

  6. 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

    Measured: 2020-2024

Secondary outcomes (3)

  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

    Measured: 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.

    Measured: 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:

    1. 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)

    Measured: 2023-2028

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2023
  2. Study start1 Jan 2020
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05692778
Sponsor's protocol ID
Dnr 2020-02175
Status last verified
Apr 2024
First submitted
7 Jan 2023
Last updated
17 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38169667

  • 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.

    PubMed 37463012

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes and Diabetic Foot, run by Sahlgrenska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ulla Hellstrand Tang, PhD (0046706397913, ulla.tang@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validation (time frame: 2020-2021). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05692778, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.

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