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Induce (Intellin Diabetic Foot) Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03591081
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : August 20, 2020
Sponsor:
Collaborators:
Innovate UK
Gendius Limited
Information provided by (Responsible Party):
Natalie Garratt, Salford Royal NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE May 31, 2018
First Posted Date  ICMJE July 18, 2018
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE June 22, 2018
Actual Primary Completion Date March 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
  • 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
  • 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%
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
  • 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.
  • Proportion of patients who access the Intellin app every day [ Time Frame: 12 months ]
    Case report form and the app electronic database
  • Proportion of patients who discontinue the study because they are unable to use the app [ Time Frame: 12 months ]
    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 [ Time Frame: 12 months ]
    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 [ Time Frame: 12 months ]
    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% [ Time Frame: 12 months ]
    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 [ Time Frame: 12 months ]
    Case report form
  • Time to recurrence of ulcer over 12 months. [ Time Frame: 12 months ]
    Data will be compared to published rates
  • 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
  • The effect of using INTELLIN on quality of life [ Time Frame: 12 months ]
    EQ-5D-5L questionnaire
  • The proportion of patients with recurrence of foot ulcer over 12 months [ Time Frame: 12 months ]
    As compared to published data
  • The proportion of patients with lower limb amputations [ Time Frame: 12 months ]
    As compared to published data
  • Changes in cardiovascular markers [ Time Frame: 12 months ]
    Blood pressure measurements, blood test results and medication
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Induce (Intellin Diabetic Foot) Feasibility Study
Official Title  ICMJE 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.
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 .
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healed Ulcer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: Intellin smart phone application
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2020)
19
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2018)
40
Actual Study Completion Date  ICMJE March 20, 2020
Actual Primary Completion Date March 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03591081
Other Study ID Numbers  ICMJE S18DIAB04-S
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Natalie Garratt, Salford Royal NHS Foundation Trust
Study Sponsor  ICMJE Natalie Garratt
Collaborators  ICMJE
  • Innovate UK
  • Gendius Limited
Investigators  ICMJE
Principal Investigator: Joanne McCardle Salford Royal NHS Foundation Trust
PRS Account Salford Royal NHS Foundation Trust
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP