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Completed

NCT Number: NCT03591081

Induce (Intellin Diabetic Foot) Feasibility Study

This is a novel feasibility study to test the participant acceptance and usability of a specifically designed smart phone app. It will also explore the effects of smart phone technology in improving self-referrals into the diabetic foot ulcer (DFU) service. Furthermore, it will be explored if this increase in self-referrals will influence the outcome of people with diabetes who have recently had a healed foot ulceration.

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Key information

Conditions

Healed Ulcer Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Podiatry Department Salford Royal NHS Foundation Trust

Salford, M6 8HD, United Kingdom

About this study

The rationale behind this study is if the investigators can introduce a new technology (a smart phone app) which is acceptable to patients, engages them and prompts people to take preventative health behaviours then the investigators may be able to influence the low rates of appropriate self-referral. There is evidence that links poor glycaemic control and hypertension to DFUs, so engagement in these areas of wider diabetes management needs to be reviewed, the latest National Diabetes Audit (NDA) shows only 20% of people with Type 1 and 42% of people with Type 2 diabetes achieve the 3 NICE standards for HbA1c, BP and cholesterol. In addition, healthcare providers are being asked to investigate new systems that may increase patient engagement with and the uptake of the NICE 8 annual care processes. The latest NDA shows only 40% of patients with type 1 and 60% of patients with type 2 diabetes currently have all 8 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 18 years of age will be screened to meet the eligibility criteria:
  • Consultant or GP diagnosis of diabetes mellitus (Type I or II) , documented on the electronic patient record with HbA1C greater than 48mmol/mol
  • History of a recent diabetes foot ulcer defined as being eligible for the national diabetes foot audit and classified as healed for at least 4 weeks and no more than 12 weeks
  • Able to provide informed consent
  • Has no reasons that they could not be part of the study for 12 months such as moving out the area for attending appointments or short life expectancy from a diagnosed illness
  • Owns a smart phone

Exclusion criteria

  • No smart phone
  • Comorbidity such as poor eyesight which limits the use of smart phone
  • Participation in an interventional study within the last 30 days
  • Critical illness that prevents participating for a period of time

Treatment and study plan

Intellin smart phone application

Other

This feasibility study will explore if creating an electronic platform Intellin smart phone application can promote and support timely self-referral for individuals with a recently healed DFU. It will explore the software applications acceptance and ease of use for patients.

Primary outcomes

  1. 1 Acceptability, suitability and usability of the INTELLIN platform

    Time frame: 12 months

    A 5-point rating scale as assessed by the participants and the clinical team. The 5 point rating is a likert scale where respondants are offered a choice of 5 pre coded responses 1 being strongly disagree 2 disagree 3 (neutral point) niether disagree or agree 4 agree and 5 strongly agree so the individual can express how much they agree or disagree with the experience of using the application

  2. The proportion of patients who self-refer for recurrence of diabetic foot-ulcer over a twelve-month period, compared with the current National diabetes foot audit average of 33.3%

    Time frame: 12 months

    Proportion of participants self-referring using the Intellin platform SOS button over 12 months compared with the current National diabetes foot audit average of 33.3%

Secondary outcomes

  1. Proportion of patients who would recommend Intellin platform to others

    Time frame: 12 months

    A 5-point rating scale as assessed by the participants and the clinical team A 5-point rating scale as assessed by the participants and the clinical team. The 5 point rating is a likert scale where respondants are offered a choice of 5 pre coded responses 1 being strongly disagree 2 disagree 3 (neutral point) niether disagree or agree 4 agree and 5 strongly agree so the individual can express how much they agree or disagree with the experience of using the application.

  2. Proportion of patients who access the Intellin app every day

    Time frame: 12 months

    Case report form and the app electronic database

  3. Proportion of patients who discontinue the study because they are unable to use the app

    Time frame: 12 months

    Case report form

  4. The proportion of patients who report that the INTELLIN app has improved their understanding of the need for the 8 annual checks

    Time frame: 12 months

    Case report form and the app electronic database

  5. The proportion of patients who report that the INTELLIN app has improved their understanding of the management of their diabetes

    Time frame: 12 months

    Case report form and the app electronic database

  6. Proportion of patients completing NICE 8 point annual checks over 12 months compared with the current national diabetes foot audit average of 60%

    Time frame: 12 months

    Case report form and the app electronic database

  7. Proportion of self-referrals that are deemed by the Clinician to be appropriate according to NICE guidelines

    Time frame: 12 months

    Case report form

  8. Time to recurrence of ulcer over 12 months.

    Time frame: 12 months

    Data will be compared to published rates

  9. The impact of using INTELLIN on healthcare utilisation and costs associated with Diabetic Foot Ulcers

    Time frame: 12 months

    Drivers of cost utilisation to include, number of GP visits, outpatient visits, hospital bed medication and type of medication, procedures for patients that develop an ulcer

  10. The effect of using INTELLIN on quality of life

    Time frame: 12 months

    EQ-5D-5L questionnaire

  11. The proportion of patients with recurrence of foot ulcer over 12 months

    Time frame: 12 months

    As compared to published data

  12. The proportion of patients with lower limb amputations

    Time frame: 12 months

    As compared to published data

  13. Changes in cardiovascular markers

    Time frame: 12 months

    Blood pressure measurements, blood test results and medication

Sponsors and collaborators

Lead sponsor

Natalie Garratt

Other

Collaborators

  • Gendius Ltd
  • Innovate UK

Registry information

Official study title

A Feasibility Study to Explore the Implementation and Acceptance of INTELLIN, a Novel mHealth Application on the Management of People With Diabetes Who Have Recently Healed Foot Ulceration.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 18, 2018
Registry last updated
Aug 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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