Healed UlcerNCT03591081
Induce (Intellin Diabetic Foot) Feasibility Study
A study testing Intellin smart phone application in people with Healed Ulcer, run by Natalie Garratt at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healed Ulcer
- What is being tested?
- Intellin smart phone application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jun 2018to 20 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Podiatry Department Salford Royal NHS Foundation Trust
Salford, M6 8HD
About this 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.
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.
Read the 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 .
- Conditions
- Healed Ulcer
- Being tested
- Intellin smart phone application
- Keywords
- Diabetic foot
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intellin smart phone applicationOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intellin smart phone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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%
Measured: 12 months
Secondary outcomes (13)
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.
Measured: 12 months
Proportion of patients who access the Intellin app every day
Case report form and the app electronic database
Measured: 12 months
Proportion of patients who discontinue the study because they are unable to use the app
Case report form
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Proportion of self-referrals that are deemed by the Clinician to be appropriate according to NICE guidelines
Case report form
Measured: 12 months
Time to recurrence of ulcer over 12 months.
Data will be compared to published rates
Measured: 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
Measured: 12 months
The effect of using INTELLIN on quality of life
EQ-5D-5L questionnaire
Measured: 12 months
The proportion of patients with recurrence of foot ulcer over 12 months
As compared to published data
Measured: 12 months
The proportion of patients with lower limb amputations
As compared to published data
Measured: 12 months
Changes in cardiovascular markers
Blood pressure measurements, blood test results and medication
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start22 Jun 2018
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healed UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natalie Garratt
- Sponsor type
- University, hospital or other
- Collaborators
- Innovate UK, Gendius Ltd
- Responsible party
- Sponsor-investigator, Natalie Garratt, Northern Care Alliance NHS Foundation Trust
- Investigators
- Joanne McCardle, Principal investigator, Northern Care Alliance NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591081
- Sponsor's protocol ID
- S18DIAB04-S
- Status last verified
- Aug 2020
- First submitted
- 31 May 2018
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03591081
- Acronym / sponsor ID
- S18DIAB04-S
- Conditions
- Healed Ulcer
- Keywords
- Diabetic foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Natalie GarrattUniversity, hospital or other
- Collaborators
- Innovate UK, Gendius Ltd
- Study start
- 22 Jun 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intellin smart phone application | Other | Other: Intellin smart phone applicationParticipants will download a smart phone app, the platform will give the patients daily hints and tips on how to look after their feet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • 18 years of age will be screened to meet the eligibility criteria:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intellin smart phone applicationThis 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. | Other | Intellin smart phone application |
Primary outcome
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%
13 secondary outcomes
Proportion of patients who would recommend Intellin platform to others
Time frame: 12 months
Proportion of patients who access the Intellin app every day
Time frame: 12 months
Proportion of patients who discontinue the study because they are unable to use the app
Time frame: 12 months
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
The proportion of patients who report that the INTELLIN app has improved their understanding of the management of their diabetes
Time frame: 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%
Time frame: 12 months
Proportion of self-referrals that are deemed by the Clinician to be appropriate according to NICE guidelines
Time frame: 12 months
Time to recurrence of ulcer over 12 months.
Time frame: 12 months
The impact of using INTELLIN on healthcare utilisation and costs associated with Diabetic Foot Ulcers
Time frame: 12 months
The effect of using INTELLIN on quality of life
Time frame: 12 months
The proportion of patients with recurrence of foot ulcer over 12 months
Time frame: 12 months
The proportion of patients with lower limb amputations
Time frame: 12 months
Changes in cardiovascular markers
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne McCardle principal investigator
Northern Care Alliance NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intellin smart phone application in people with Healed Ulcer, run by Natalie Garratt at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 Acceptability, suitability and usability of the INTELLIN platform (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020.