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

Brief Summary:
This mixed methods study aims to answer the question: "What is the work of being a patient with type 2 diabetes mellitus?" .

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 2 Other: none, observational study

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.

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Study Type : Observational
Actual Enrollment : 162 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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
Study Start Date : February 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Participants with Type 2 Diabetes
Adults with type 2 diabetes will be enrolled in this mixed methods observational study.
Other: none, observational study

Primary Outcome Measures :
  1. Mean Score on Burden of Treatment Questionnaire [ Time Frame: Baseline ]
    The 48-item version of the Patient Experience with Treatment and Self-Care (PETS)

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with type 2 diabetes with receiving care at Mayo Clinic endocrinology department.

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

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 identifier (NCT number): NCT02714660

Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: Victor Montori, MD Mayo Clinic
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Responsible Party: Victor Montori, MD, Mayo Clinic Identifier: NCT02714660    
Other Study ID Numbers: 15-005767
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases