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

NCT03934944 | Unknown

• 1 other identifier: RA HM-2018_044
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Diabetic Foot Ulcer

Keywords

Patient education; Prevention; Smart phone application

Outcome Measures

Primary Outcomes (2)

• Change in foot care knowledge as measured by the adapted foot care knowledge test

  Change in the adapted Diabetic Foot Care Knowledge test (Pollock et al. 2004 and Rheeder et al. 2008) score between baseline and 12-months in the two groups This 12-question test has a maximum score of 12, and a minimum score of 0. Each correct answer is given one point, where a low score denotes low knowledge and high score denotes high knowledge. For each group a mean will be calculated and significance of differences will be tested using the students two tailed unpaired T-Test.

  12 months

• Change in foot care behaviour as measured by the SDSCA

  SDCS questionnaire includes a number of domains which evaluate different aspects of patient behaviour performed during the previous week. Each domain has one or more questions that are marked between 0-7. The domains are: 1. Foot care: total of 9 questions with maximum score 9x7 = 63, the greater the score the better the behaviour 2. Diabetes Management: 4 questions in diabetes management, maximum score 4x7 = 28, the greater the score the better the behaviour 3. Smoking habits: number of cigarettes per day, the greater the number the worse the behaviour These measures allow formulation of a composite reflection in changes in the patient's behaviour between baseline and 12-months in the two groups. Differences will be tested using the students two-tailed unpaired T-Test.

  12 months

Secondary Outcomes (2)

• Change in HbA1c from baseline

  12 months

• Proportion of participants who developed a new diabetic foot ulcer

  12 months

Study Arms (2)

Phone application arm

EXPERIMENTAL

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

Device: Phone application

Usual care

OTHER

Participants will have Podiatry care and education.

Other: Usual care

Interventions

Phone application DEVICE

Weekly foot alerts and educational video

Also known as: MyU smart phone application

Phone application arm

Usual care OTHER

Usual routine of diabetic foot education

Also known as: Routine Podiatry education

Usual care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dasman Diabetes Institute: lead
• Kuwait Foundation for the Advancement of Sciences: collaborator

Study Sites (1)

Dasman Diabetes Institute

Kuwait City, Kuwait

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Kay Scarsbrook Khan, BSc

  Dasman Diabetes Institute

  PRINCIPAL INVESTIGATOR

• Ebaa Al Ozairi, MD

  Dasman Diabetes Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kay Scarsbrook Khan, BSc

CONTACT

+965 22242999; kay.khan@dasmaninstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: May 2, 2019
• Study Start: February 10, 2019
• Primary Completion: February 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 17, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KU (1)