Diabetes Mellitus, Type 2NCT02714660
The Work of Being a Patient With Diabetes: Data Collection Via a Smartphone Application
An observational study of Diabetes Mellitus, Type 2, run by Mayo Clinic.
Trial summary
This mixed methods study aims to answer the question: "What is the work of being a patient with type 2 diabetes mellitus?" . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- none, observational study
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with type 2 diabetes with receiving care at Mayo Clinic endocrinology department.
Who may be able to join
- receiving medical care at Mayo Clinic endocrine subspecialty clinic
- diagnosis of type 2 diabetes
Who cannot join
- unable to provide consent
- patients who reside in an extended care of intermediate care facility
About this study
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
This mixed methods study aims to answer the question: "What is the work of being a patient with type 2 diabetes mellitus?" .
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- none, observational study
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none, observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| Participants with Type 2 Diabetes | Adults with type 2 diabetes will be enrolled in this mixed methods observational study. Receives: Other: none, observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Score on Burden of Treatment Questionnaire
The 48-item version of the Patient Experience with Treatment and Self-Care (PETS)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Montori, Mayo Clinic
- Investigators
- Victor Montori, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714660
- Sponsor's protocol ID
- 15-005767
- Status last verified
- Oct 2017
- First submitted
- 17 Mar 2016
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02714660
- Acronym / sponsor ID
- 15-005767
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Type 2 Diabetes | – | Other: none, observational studyAdults with type 2 diabetes will be enrolled in this mixed methods observational study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with type 2 diabetes with receiving care at Mayo Clinic endocrinology department.
Key inclusion criteria (2 listed)
- receiving medical care at Mayo Clinic endocrine subspecialty clinic
- diagnosis of type 2 diabetes
Key exclusion criteria (2 listed)
- unable to provide consent
- patients who reside in an extended care of intermediate care facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| none, observational study | Other | Participants with Type 2 Diabetes |
Primary outcome
Mean Score on Burden of Treatment Questionnaire
Time frame: Baseline
The 48-item version of the Patient Experience with Treatment and Self-Care (PETS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Montori, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Score on Burden of Treatment Questionnaire (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.