Induce (Intellin Diabetic Foot) Feasibility Study

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.

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.

Study Overview

• Status: Completed
• Conditions: Healed Ulcer
• Intervention / Treatment: Other: Intellin smart phone application

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Salford, United Kingdom, M6 8HD
    • Podiatry Department Salford Royal NHS Foundation Trust

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 Acceptability, suitability and usability of the INTELLIN platform	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	12 months
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%	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%	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who would recommend Intellin platform to others	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.	12 months
Proportion of patients who access the Intellin app every day	Case report form and the app electronic database	12 months
Proportion of patients who discontinue the study because they are unable to use the app	Case report form	12 months
The proportion of patients who report that the INTELLIN app has improved their understanding of the need for the 8 annual checks	Case report form and the app electronic database	12 months
The proportion of patients who report that the INTELLIN app has improved their understanding of the management of their diabetes	Case report form and the app electronic database	12 months
Proportion of patients completing NICE 8 point annual checks over 12 months compared with the current national diabetes foot audit average of 60%	Case report form and the app electronic database	12 months
Proportion of self-referrals that are deemed by the Clinician to be appropriate according to NICE guidelines	Case report form	12 months
Time to recurrence of ulcer over 12 months.	Data will be compared to published rates	12 months
The impact of using INTELLIN on healthcare utilisation and costs associated with Diabetic Foot Ulcers	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	12 months
The effect of using INTELLIN on quality of life	EQ-5D-5L questionnaire	12 months
The proportion of patients with recurrence of foot ulcer over 12 months	As compared to published data	12 months
The proportion of patients with lower limb amputations	As compared to published data	12 months
Changes in cardiovascular markers	Blood pressure measurements, blood test results and medication	12 months

Collaborators and Investigators

• Sponsor: Natalie Garratt
• Collaborators: Innovate UK; Gendius Ltd
• Investigators: Principal Investigator: Joanne McCardle, Northern Care Alliance NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2018
• Primary Completion (Actual): March 20, 2020
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Diabetic foot
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: S18DIAB04-S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No