The Work of Being a Patient With Diabetes: Data Collectio... | NCT02714660

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

NCT02714660

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Oct 11, 2017Actual

Enrollment

162Actual

Phase

Not provided

Conditions

Diabetes Mellitus, Type 2

Interventions

none, observational study

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Apr 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Mar 17, 2016

First Submission Date that Met QC Criteria

Mar 17, 2016

First Posted Date

Mar 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2017

Last Update Posted Date

Oct 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

162Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants with Type 2 Diabetes		Adults with type 2 diabetes will be enrolled in this mixed methods observational study.	Other: none, observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
none, observational study	Other		Participants with Type 2 Diabetes

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Victor Montori, MD	Mayo Clinic	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided