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

October 9, 2017 updated by: Victor Montori, Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with type 2 diabetes with receiving care at Mayo Clinic endocrinology department.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Score on Burden of Treatment Questionnaire
Time Frame: Baseline
The 48-item version of the Patient Experience with Treatment and Self-Care (PETS)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 21, 2016

Study Record Updates

Last Update Posted (Actual)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-005767

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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