NCT02714660

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

March 17, 2016

Last Update Submit

October 9, 2017

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Mean Score on Burden of Treatment Questionnaire

    The 48-item version of the Patient Experience with Treatment and Self-Care (PETS)

    Baseline

Study Arms (1)

Participants with Type 2 Diabetes

Adults with type 2 diabetes will be enrolled in this mixed methods observational study.

Other: none, observational study

Interventions

none, observational studyOTHER
Participants with Type 2 Diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • unable to provide consent
  • patients who reside in an extended care of intermediate care facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Observation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Victor Montori, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 21, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2017

Study Completion

August 1, 2017

Last Updated

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share