Induce (Intellin Diabetic Foot) Feasibility Study

• ClinicalTrials.gov Identifier: NCT03591081
• Recruitment Status: Enrolling by invitation
• First Posted: July 18, 2018
• Last Update Posted: February 7, 2020
• Sponsor: Natalie Garratt
• Collaborators: Innovate UK; Gendius Limited
• Information provided by (Responsible Party): Natalie Garratt, Salford Royal NHS Foundation Trust

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healed Ulcer	Other: Intellin smart phone application	Not Applicable

Detailed Description:

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 .

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official 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.
• Actual Study Start Date: June 22, 2018
• Estimated Primary Completion Date: September 30, 2020
• Estimated Study Completion Date: September 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Intellin smart phone application; Participants will download a smart phone app, the platform will give the patients daily hints and tips on how to look after their feet.	Other: Intellin smart phone application; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United Kingdom

Podiatry Department Salford Royal NHS Foundation Trust

Salford, United Kingdom, M6 8HD

Sponsors and Collaborators

Natalie Garratt

Innovate UK

Gendius Limited

Investigators

• Principal Investigator: Joanne McCardle; Salford Royal NHS Foundation Trust

More Information

• Responsible Party: Natalie Garratt, Research & Development Lead, Salford Royal NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT03591081
• Other Study ID Numbers: S18DIAB04-S
• First Posted: July 18, 2018
• Last Update Posted: February 7, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Natalie Garratt, Salford Royal NHS Foundation Trust:

Diabetic foot

Additional relevant MeSH terms:

Diabetes Complications; Diabetes Mellitus; Diabetic Foot; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Endocrine System Diseases; Diabetic Neuropathies