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.
Intellin smart phone application
Cardiovascular Diseases+10
+ Diabetes Mellitus
+ Diabetic Angiopathies
Prevention Study
Summary
Study start date: June 22, 2018
Actual date on which the first participant was enrolled.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 .
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.19 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Podiatry Department Salford Royal NHS Foundation Trust
Salford, United KingdomOpen Podiatry Department Salford Royal NHS Foundation Trust in Google Maps