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
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Foot Diabetic Foot Ulcer||Device: Phone application Other: Usual care||Not Applicable|
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
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel assignment|
|Masking:||Double (Care Provider, Investigator)|
|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|
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
Participants will have Podiatry care and education.
Other: Usual care
Usual routine of diabetic foot education
Other Name: Routine Podiatry education
- 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:
- Foot care: total of 9 questions with maximum score 9x7 = 63, the greater the score the better the behaviour
- Diabetes Management: 4 questions in diabetes management, maximum score 4x7 = 28, the greater the score the better the behaviour
- 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.
- 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.
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
|Contact: Grace Messenger, MRes||+965 22242999 ext email@example.com|
|Contact: Richard Masoetsa, MSc||+965 22242999 ext firstname.lastname@example.org|
|Dasman Diabetes Institute||Recruiting|
|Contact: Grace Messenger, MRes +96522242999 ext 6408 email@example.com|
|Principal Investigator:||Grace Messenger, MRes||Dasman Diabetes Institute|
|Principal Investigator:||Ebaa Al Ozairi, MD||Dasman Diabetes Institute|