Healed Ulcer Clinical Trial
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.
| Verified date | August 2020 |
| Source | Salford Royal NHS Foundation Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 19 |
| Est. completion date | March 20, 2020 |
| Est. primary completion date | March 20, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Podiatry Department Salford Royal NHS Foundation Trust | Salford |
| Lead Sponsor | Collaborator |
|---|---|
| Natalie Garratt | Gendius Limited, Innovate UK |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | 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. | 12 months | |
| Secondary | Proportion of patients who access the Intellin app every day | Case report form and the app electronic database | 12 months | |
| Secondary | Proportion of patients who discontinue the study because they are unable to use the app | Case report form | 12 months | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Proportion of self-referrals that are deemed by the Clinician to be appropriate according to NICE guidelines | Case report form | 12 months | |
| Secondary | Time to recurrence of ulcer over 12 months. | Data will be compared to published rates | 12 months | |
| Secondary | 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 | |
| Secondary | The effect of using INTELLIN on quality of life | EQ-5D-5L questionnaire | 12 months | |
| Secondary | The proportion of patients with recurrence of foot ulcer over 12 months | As compared to published data | 12 months | |
| Secondary | The proportion of patients with lower limb amputations | As compared to published data | 12 months | |
| Secondary | Changes in cardiovascular markers | Blood pressure measurements, blood test results and medication | 12 months |