Clinical trial NCT03934944: A Feasibility Study Comparing Usual Foot Education and Phone App Alerts in Patients With Increased Risk of Diabetic Foot
Official title: A Feasibility Study to Compare Usual Methods of Patient Education With a Multi-media Presentation and Weekly 'Foot-alerts' Using 21st Century Technologies to Improve Patient Diabetic Foot Care Knowledge and Practices
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot
Diabetic Foot Ulcer
Keywords: Patient education
Prevention
Smart phone application
Lead sponsor: Dasman Diabetes Institute
Sponsor class: OTHER
Collaborators: name: Kuwait Foundation for the Advancement of Sciences
First posted: 2019-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare foot care knowledge, behaviour and glycaemic control in patients at increased risk of diabetic foot ulcers. Participants will receive either usual diabetic foot care education and follow-up as per evidence-based guidelines or usual care and follow-up, supplemented with an educational video and weekly foot alerts via a phone application.

Detailed description: It is recommended that patients who are at moderate or high risk of diabetic foot ulcer (DFU) are seen by a healthcare professional for foot review every 2-6 months. Yet, diabetic foot ulcers remain the leading cause of non-traumatic lower limb amputation with an amputation occurring every 20 secs. This suggests that additional information and prompts, as well as regular follow-up, are required. Additionally, long term diabetic foot complications including loss of protective pain sensation are related to poor glycaemic control.

This single blinded randomised study aims to determine if weekly foot alerts (a total of 12 alerts cycled over 12-months), delivered by the MyU phone application in combination with usual education routes and follow-up, improves patient foot care behaviour and foot care knowledge. Using standardized questionnaires at baseline and 12-months. Furthermore, does the frequency of viewing/engaging in foot alert content influence foot care knowledge and behaviour.

Secondary objectives are to determine: 1) if individuals who receive 7-foot review appointments in a 12-month period have better foot care knowledge and behaviour when compared to those seen less frequently regardless of educational route. 2) Baseline and 12-months HbA1c blood test will be measured to establish if any changes occurred between the two groups.

Expected results: The investigators hypothesized that participants randomised to the intervention group (Phone app) will have improved foot care knowledge and foot health behaviours.

Sample size: 100 patients with a 1:1 ratio

Quality Assurance:

A standard operating procedure based on established diabetic foot screening tools will be used to ensure the inter-rater reliability of foot assessment.

Educational material will go through back translation to ensure the accuracy of the content. Feedback on content, meaning and usability of the English and Arabic documents from a sample of 10 participants will be sought.

To maintain investigator blinding the participants will be escorted to the video viewing room by a research coordinator.

Eligibility criteria: Inclusion Criteria:

* Male or female 21 yrs or
* Type 2 Diabetes Mellitus or Type 1 Diabetes Mellitus greater than 5-yrs
* At least one diabetic foot risk factor (i.e Loss of Pain Sensation Peripheral Arterial Disease etc)
* Ability to understand Arabic or English to a skill listening level 3 and speaking level +2 (Interagency Language Roundtable).
* Own a smartphone and access to the internet
* The ability to understand the study procedures and to comply with them for the entire length of the study
* Resident in Kuwait

Exclusion Criteria:

* Chronic kidney disease stage 3 or above
* Cognitive impairment
* Acute psychiatric illness
* Hearing or visual impairment that would mean the intervention would not be understood
* phone application inaccessible for more than 4 continuous weeks
* Refusal to give written informed consent

Primary outcomes:
measure: Change in foot care knowledge as measured by the adapted foot care knowledge test
timeFrame: 12 months
measure: Change in foot care behaviour as measured by the SDSCA
timeFrame: 12 months
Secondary outcomes:
measure: Change in HbA1c from baseline
timeFrame: 12 months
measure: Proportion of participants who developed a new diabetic foot ulcer
timeFrame: 12 months
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Dasman Diabetes Institute
Study officials:
affiliation: Dasman Diabetes Institute
name: Kay Scarsbrook Khan, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Dasman Diabetes Institute
name: Ebaa Al Ozairi, MD
role: PRINCIPAL_INVESTIGATOR
References: