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| Name | Class |
|---|---|
| Innovate UK | OTHER_GOV |
| Gendius Ltd | INDUSTRY |
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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
• 18 years of age will be screened to meet the eligibility criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne McCardle | Northern Care Alliance NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Podiatry Department Salford Royal NHS Foundation Trust | Salford | M6 8HD | United Kingdom |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| 12 months |
| Proportion of patients who access the Intellin app every day | Case report form and the app electronic database | 12 months |
| Proportion of patients who discontinue the study because they are unable to use the app | Case report form | 12 months |
| 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 | 12 months |
| 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 | 12 months |
| 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 | 12 months |
| Proportion of self-referrals that are deemed by the Clinician to be appropriate according to NICE guidelines | Case report form | 12 months |
| Time to recurrence of ulcer over 12 months. | Data will be compared to published rates | 12 months |
| 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 | 12 months |
| The effect of using INTELLIN on quality of life | EQ-5D-5L questionnaire | 12 months |
| The proportion of patients with recurrence of foot ulcer over 12 months | As compared to published data | 12 months |
| The proportion of patients with lower limb amputations | As compared to published data | 12 months |
| Changes in cardiovascular markers | Blood pressure measurements, blood test results and medication | 12 months |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |