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Induce (Intellin Diabetic Foot) Feasibility Study

Primary Purpose

Healed Ulcer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intellin smart phone application
Sponsored by
Natalie Garratt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healed Ulcer focused on measuring Diabetic foot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Podiatry Department Salford Royal NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intellin smart phone application

Arm Description

Participants will download a smart phone app, the platform will give the patients daily hints and tips on how to look after their feet.

Outcomes

Primary Outcome Measures

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
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%

Secondary Outcome Measures

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.
Proportion of patients who access the Intellin app every day
Case report form and the app electronic database
Proportion of patients who discontinue the study because they are unable to use the app
Case report form
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
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
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
Proportion of self-referrals that are deemed by the Clinician to be appropriate according to NICE guidelines
Case report form
Time to recurrence of ulcer over 12 months.
Data will be compared to published rates
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
The effect of using INTELLIN on quality of life
EQ-5D-5L questionnaire
The proportion of patients with recurrence of foot ulcer over 12 months
As compared to published data
The proportion of patients with lower limb amputations
As compared to published data
Changes in cardiovascular markers
Blood pressure measurements, blood test results and medication

Full Information

First Posted
May 31, 2018
Last Updated
August 19, 2020
Sponsor
Natalie Garratt
Collaborators
Innovate UK, Gendius Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03591081
Brief Title
Induce (Intellin Diabetic Foot) Feasibility Study
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 22, 2018 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Natalie Garratt
Collaborators
Innovate UK, Gendius Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healed Ulcer
Keywords
Diabetic foot

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intellin smart phone application
Arm Type
Other
Arm Description
Participants will download a smart phone app, the platform will give the patients daily hints and tips on how to look after their feet.
Intervention Type
Other
Intervention Name(s)
Intellin smart phone application
Intervention Description
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 Outcome Measure Information:
Title
1 Acceptability, suitability and usability of the INTELLIN platform
Description
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
Title
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%
Description
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 Outcome Measure Information:
Title
Proportion of patients who would recommend Intellin platform to others
Description
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
Title
Proportion of patients who access the Intellin app every day
Description
Case report form and the app electronic database
Time Frame
12 months
Title
Proportion of patients who discontinue the study because they are unable to use the app
Description
Case report form
Time Frame
12 months
Title
The proportion of patients who report that the INTELLIN app has improved their understanding of the need for the 8 annual checks
Description
Case report form and the app electronic database
Time Frame
12 months
Title
The proportion of patients who report that the INTELLIN app has improved their understanding of the management of their diabetes
Description
Case report form and the app electronic database
Time Frame
12 months
Title
Proportion of patients completing NICE 8 point annual checks over 12 months compared with the current national diabetes foot audit average of 60%
Description
Case report form and the app electronic database
Time Frame
12 months
Title
Proportion of self-referrals that are deemed by the Clinician to be appropriate according to NICE guidelines
Description
Case report form
Time Frame
12 months
Title
Time to recurrence of ulcer over 12 months.
Description
Data will be compared to published rates
Time Frame
12 months
Title
The impact of using INTELLIN on healthcare utilisation and costs associated with Diabetic Foot Ulcers
Description
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
Time Frame
12 months
Title
The effect of using INTELLIN on quality of life
Description
EQ-5D-5L questionnaire
Time Frame
12 months
Title
The proportion of patients with recurrence of foot ulcer over 12 months
Description
As compared to published data
Time Frame
12 months
Title
The proportion of patients with lower limb amputations
Description
As compared to published data
Time Frame
12 months
Title
Changes in cardiovascular markers
Description
Blood pressure measurements, blood test results and medication
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne McCardle
Organizational Affiliation
Northern Care Alliance NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Podiatry Department Salford Royal NHS Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Induce (Intellin Diabetic Foot) Feasibility Study

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