Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Diabetic Foot Ulcer Device: Phone application Other: Usual care Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : February 10, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: Phone application
Weekly foot alerts and educational video
Other Name: MyU smart phone application

Usual care
Participants will have Podiatry care and education.
Other: Usual care
Usual routine of diabetic foot education
Other Name: Routine Podiatry education




Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934944


Contacts
Layout table for location contacts
Contact: Grace Messenger, MRes +965 22242999 ext 6408 grace.messenger@dasmaninstitute.org
Contact: Richard Masoetsa, MSc +965 22242999 ext 6815 richard.masoetsa@dasmaninstitute.org

Locations
Layout table for location information
Kuwait
Dasman Diabetes Institute Recruiting
Kuwait, Kuwait
Contact: Grace Messenger, MRes    +96522242999 ext 6408    grace.messenger@dasmaninstitute.org   
Sponsors and Collaborators
Dasman Diabetes Institute
Kuwait Foundation for the Advancement of Sciences
Investigators
Layout table for investigator information
Principal Investigator: Grace Messenger, MRes Dasman Diabetes Institute
Principal Investigator: Ebaa Al Ozairi, MD Dasman Diabetes Institute

Layout table for additonal information
Responsible Party: Dasman Diabetes Institute
ClinicalTrials.gov Identifier: NCT03934944     History of Changes
Other Study ID Numbers: RA HM-2018_044
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dasman Diabetes Institute:
Patient education
Prevention
Smart phone application
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases