Induce (Intellin Diabetic Foot) Feasibility Study

NCT03591081 | Completed

• 1 other identifier: S18DIAB04-S
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Healed Ulcer

Keywords

Diabetic foot

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Proportion of patients who would recommend Intellin platform to others

  12 months

• Proportion of patients who access the Intellin app every day

  12 months

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

  12 months

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

  12 months

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

  12 months

Study Arms (1)

Intellin smart phone application

OTHER

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

Interventions

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.

Intellin smart phone application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Natalie Garratt: lead
• Innovate UK: collaborator
• Gendius Ltd: collaborator

Study Sites (1)

Podiatry Department Salford Royal NHS Foundation Trust

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

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

Study Officials

• Joanne McCardle

  Northern Care Alliance NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research & Development Lead

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: July 18, 2018
• Study Start: June 22, 2018
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)