Clinical trial NCT03591081: 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
Overall status: COMPLETED
Phase: NA
Conditions: Healed Ulcer
Keywords: Diabetic foot
Lead sponsor: Northern Care Alliance NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Innovate UK
name: Gendius Ltd
First posted: 2018-07-18
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 .

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

Primary outcomes:
measure: 1 Acceptability, suitability and usability of the INTELLIN platform
timeFrame: 12 months
measure: 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%
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients who would recommend Intellin platform to others
timeFrame: 12 months
measure: Proportion of patients who access the Intellin app every day
timeFrame: 12 months
measure: Proportion of patients who discontinue the study because they are unable to use the app
timeFrame: 12 months
measure: The proportion of patients who report that the INTELLIN app has improved their understanding of the need for the 8 annual checks
timeFrame: 12 months
measure: The proportion of patients who report that the INTELLIN app has improved their understanding of the management of their diabetes
timeFrame: 12 months
measure: Proportion of patients completing NICE 8 point annual checks over 12 months compared with the current national diabetes foot audit average of 60%
timeFrame: 12 months
measure: Proportion of self-referrals that are deemed by the Clinician to be appropriate according to NICE guidelines
timeFrame: 12 months
measure: Time to recurrence of ulcer over 12 months.
timeFrame: 12 months
measure: The impact of using INTELLIN on healthcare utilisation and costs associated with Diabetic Foot Ulcers
timeFrame: 12 months
measure: The effect of using INTELLIN on quality of life
timeFrame: 12 months
measure: The proportion of patients with recurrence of foot ulcer over 12 months
timeFrame: 12 months
measure: The proportion of patients with lower limb amputations
timeFrame: 12 months
measure: Changes in cardiovascular markers
timeFrame: 12 months
Other outcomes:
Locations:
city: Salford
country: United Kingdom
facility: Podiatry Department Salford Royal NHS Foundation Trust
Study officials:
affiliation: Northern Care Alliance NHS Foundation Trust
name: Joanne McCardle
role: PRINCIPAL_INVESTIGATOR
References: