A Feasibility Study Comparing Usual Foot Education and Phone App Alerts in Patients With Increased Risk of Diabetic Foot

NCT ID: NCT03934944

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-10
• Study Completion Date: 2023-04-30

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.

Conditions

Diabetic Foot; Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Phone application arm

Participants will have access to a educational video and foot alerts at weekly intervals to supplement usual Podiatry care and education.

Group Type: EXPERIMENTAL

Phone application

Intervention Type: DEVICE

Weekly foot alerts and educational video

Usual care

Participants will have Podiatry care and education.

Group Type: OTHER

Usual care

Intervention Type: OTHER

Usual routine of diabetic foot education

Interventions

Phone application

Weekly foot alerts and educational video

Intervention Type: DEVICE

Usual care

Usual routine of diabetic foot education

Intervention Type: OTHER

Other Intervention Names

MyU smart phone application; Routine Podiatry education

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuwait Foundation for the Advancement of Sciences

UNKNOWN

Sponsor Role: collaborator

Dasman Diabetes Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kay Scarsbrook Khan, BSc

Role: PRINCIPAL_INVESTIGATOR

Dasman Diabetes Institute

Ebaa Al Ozairi, MD

Role: PRINCIPAL_INVESTIGATOR

Dasman Diabetes Institute

Locations

Dasman Diabetes Institute

Kuwait City, , Kuwait

Site Status: RECRUITING

Countries

Kuwait

Central Contacts

Kay Scarsbrook Khan, BSc

Role: CONTACT

kay.khan@dasmaninstitute.org

+965 22242999 ext. 6815

Facility Contacts

Kay Scarsbrook Khan, BSc

Role: primary

kay.khan@dasmaninstitute.org

+96522242999 ext. 6815

Other Identifiers

RA HM-2018_044

Identifier Type: -

Identifier Source: org_study_id