Induce (Intellin Diabetic Foot) Feasibility Study

Natalie Garratt19 enrolled

Overview

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.

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

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Healed Ulcer

Interventions

Intellin smart phone applicationOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Podiatry Department Salford Royal NHS Foundation Trust

Salford, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 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%

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 12 months

Proportion of patients who access the Intellin app every day

Case report form and the app electronic database

Time frame: 12 months

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

Case report form

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.