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Approaches to Foot Complication Prevention: A Survey of Diabetes Educators

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400344
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2020
Last Update Posted : August 31, 2020
Sponsor:
Collaborator:
American Association of Diabetes Educators
Information provided by (Responsible Party):
Podimetrics, Inc.

Tracking Information
First Submitted Date May 18, 2020
First Posted Date May 22, 2020
Last Update Posted Date August 31, 2020
Actual Study Start Date June 13, 2020
Estimated Primary Completion Date May 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2020)
Current state of diabetic foot care education and knowledge base among diabetic educators [ Time Frame: One year ]
Survey of diabetic foot care recommendations, treatment options, risk classifications, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.
Original Primary Outcome Measures
 (submitted: May 20, 2020)
Measure the current state of diabetic foot care education and knowledge base among diabetic educators [ Time Frame: One year ]
Survey of diabetic foot care recommendations, treatment options, risk classifications, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Approaches to Foot Complication Prevention: A Survey of Diabetes Educators
Official Title Approaches to Foot Complication Prevention: A Survey of Diabetes Educators
Brief Summary The purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.
Detailed Description

Podimetrics is a care management company with a temperature-based foot monitoring solution to help prevent diabetic foot ulcers, one of the most debilitating and costly complications of diabetes.

Diabetes educators within the AADE/ADCES encompass a wide array of medical disciplines including nurses, physicians, dieticians, and pharmacists. Diabetes researchers want to better understand the degree to which diabetic foot care and prevention is incorporated into the diabetes education curriculum. To what extent are these topics discussed between diabetes educators and the patients they interact with? And how comfortable are educators in discussing these topics?

To gain insight into these questions Podimetrics researchers have designed an online questionnaire survey for completion by AADE members. The general purpose of the survey is to assess the knowledge base, role in management, and resources available to diabetes educators regarding foot complication prevention within a variety of healthcare settings.

The specific aim is to collect generalizable data to characterize the current state of diabetic foot education and identify any gaps in knowledge that may be present. Furthermore, if it is found that educators are lacking important knowledge which supports ample diabetic foot health education, approaches to bridge these gaps may be suggested through published recommendations.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Respondents are members of the American Association of Diabetes Educators (AADE) recruited via an introductory email sent out by the AADE on behalf of Podimetrics.
Condition Foot Ulcer, Diabetic
Intervention Other: No intervention
No intervention
Study Groups/Cohorts Survey Respondents
Respondents are members of the American Association of Diabetes Educators recruited via an introductory email sent out by the AADE on behalf of Podimetrics.
Intervention: Other: No intervention
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 Enrolling by invitation
Estimated Enrollment
 (submitted: May 20, 2020)
6000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 13, 2021
Estimated Primary Completion Date May 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • American Association of Diabetes Educators (AADE) member with accurate email address on file with the AADE.

Exclusion Criteria:

  • AADE member with an inability to read English.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04400344
Other Study ID Numbers A20-018-682
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
Plan to Share IPD: No
Plan Description: To protect the respondent's identity, respondent name and email address will not be recorded within the survey results. No demographic data other than relevant profession, work environment, and number of years as a certified educator will be collected. Additionally, the AADE will not share respondent's name or email addresses with Podimetrics, and the AADE will not have access to the individual survey results, effectively detaching individual results from respondents' identities.
Responsible Party Podimetrics, Inc.
Study Sponsor Podimetrics, Inc.
Collaborators American Association of Diabetes Educators
Investigators Not Provided
PRS Account Podimetrics, Inc.
Verification Date August 2020