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

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ClinicalTrials.gov Identifier: NCT03934944
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Collaborator:
Kuwait Foundation for the Advancement of Sciences
Information provided by (Responsible Party):
Dasman Diabetes Institute

Tracking Information
First Submitted Date  ICMJE March 6, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date May 2, 2019
Actual Study Start Date  ICMJE February 10, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • Change in foot care knowledge as measured by the adapted foot care knowledge test [ Time Frame: 12 months ]
    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.
  • Change in foot care behaviour as measured by the SDSCA [ Time Frame: 12 months ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • Change in HbA1c from baseline [ Time Frame: 12 months ]
    Change in HbA1c measurement taken from venous blood supply at baseline and 12-months between intervention and control group.
  • Proportion of participants who developed a new diabetic foot ulcer [ Time Frame: 12 months ]
    Case report form. Diabetic foot ulcer is defined as a wound below the ankle in someone with diabetes and will be classified using the University of Texas Wound classification System.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Feasibility Study Comparing Usual Foot Education and Phone App Alerts in Patients With Increased Risk of Diabetic Foot
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Diabetic Foot
  • Diabetic Foot Ulcer
Intervention  ICMJE
  • Device: Phone application
    Weekly foot alerts and educational video
    Other Name: MyU smart phone application
  • Other: Usual care
    Usual routine of diabetic foot education
    Other Name: Routine Podiatry education
Study Arms  ICMJE
  • Experimental: Phone application arm
    Participants will have access to a educational video and foot alerts at weekly intervals to supplement usual Podiatry care and education.
    Intervention: Device: Phone application
  • Usual care
    Participants will have Podiatry care and education.
    Intervention: Other: Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Grace Messenger, MRes +965 22242999 ext 6408 grace.messenger@dasmaninstitute.org
Contact: Richard Masoetsa, MSc +965 22242999 ext 6815 richard.masoetsa@dasmaninstitute.org
Listed Location Countries  ICMJE Kuwait
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03934944
Other Study ID Numbers  ICMJE RA HM-2018_044
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dasman Diabetes Institute
Study Sponsor  ICMJE Dasman Diabetes Institute
Collaborators  ICMJE Kuwait Foundation for the Advancement of Sciences
Investigators  ICMJE
Principal Investigator: Grace Messenger, MRes Dasman Diabetes Institute
Principal Investigator: Ebaa Al Ozairi, MD Dasman Diabetes Institute
PRS Account Dasman Diabetes Institute
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP