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The Work of Being a Patient With Diabetes: Data Collection Via a Smartphone Application

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: NCT02714660
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Victor Montori, Mayo Clinic

Tracking Information
First Submitted Date March 17, 2016
First Posted Date March 21, 2016
Last Update Posted Date October 11, 2017
Study Start Date February 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2016)
Mean Score on Burden of Treatment Questionnaire [ Time Frame: Baseline ]
The 48-item version of the Patient Experience with Treatment and Self-Care (PETS)
Original Primary Outcome Measures Same as current
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 The Work of Being a Patient With Diabetes: Data Collection Via a Smartphone Application
Official Title The Work of Being a Patient: A Mixed Methods Characterization of the Work of Being a Patient With Type 2 Diabetes Mellitus Using Real-time Data Collection Via a Smartphone Application
Brief Summary This mixed methods study aims to answer the question: "What is the work of being a patient with type 2 diabetes mellitus?" .
Detailed Description This study will describe how much time persons with type 2 diabetes mellitus spend on health management and the burden they experience from these activities.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults with type 2 diabetes with receiving care at Mayo Clinic endocrinology department.
Condition Diabetes Mellitus, Type 2
Intervention Other: none, observational study
Study Groups/Cohorts Participants with Type 2 Diabetes
Adults with type 2 diabetes will be enrolled in this mixed methods observational study.
Intervention: Other: none, observational study
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 Completed
Actual Enrollment
 (submitted: October 9, 2017)
162
Original Estimated Enrollment
 (submitted: March 17, 2016)
400
Actual Study Completion Date August 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • receiving medical care at Mayo Clinic endocrine subspecialty clinic
  • diagnosis of type 2 diabetes

Exclusion Criteria:

  • unable to provide consent
  • patients who reside in an extended care of intermediate care facility
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02714660
Other Study ID Numbers 15-005767
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Victor Montori, Mayo Clinic
Study Sponsor Mayo Clinic
Collaborators Not Provided
Investigators
Principal Investigator: Victor Montori, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2017