My Life, My Healthcare

June 3, 2020 updated by: Kasey R. Boehmer, Mayo Clinic

This study is designed to answer the following questions: "Is the My Life, My Healthcare Discussion Aid feasible for use in primary care? Does it positively impact patient and healthcare teams' care experience and communication, while reducing patient treatment burden?"

Through implementation of the My Life, My Healthcare Discussion Aid for patients with chronic conditions, the study team hypothesizes that it will be feasible to implement in routine primary care practice and positively impact patient and healthcare teams experience of chronic care, while reducing patient treatment burden.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1929

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • Primary Care Centers of East Kentucky
      • Vanceburg, Kentucky, United States, 41179
        • Lewis County Primary Care Center, Inc.
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
      • Springfield, Minnesota, United States, 56087
        • Mayo Health System - Springfield
    • North Carolina
      • Belhaven, North Carolina, United States, 27810
        • Vidant Multispecialty Clinic Belhaven
      • Charlotte, North Carolina, United States, 28207
        • Elizabeth Family Medicine
      • Charlotte, North Carolina, United States, 28208
        • CMC- Union Family Medicine
      • Chocowinity, North Carolina, United States, 28717
        • Vidant Family Medicine Chocowinity
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Mayo Clinic Health System La Crosse

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

InclusionCriteria: Particpant population will include patients 18 years of age or older who have one or more chronic conditions and do not have any barriers to consent (such as major cognitive disabilities) will be eligible for enrollment. Clinicians who treat patients with chronic conditions at participating sites are eligible for enrollment.

Exclusion Criteria: Patients who do not have a chronic condition, or have barriers to consent such as cognitive impairment will be excluded from the study. Health professionals who do not treat patients with chronic conditions will not be included.

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Sites randomized to intervention will be expected to implement the My Life, My Healthcare Discussion Aid in their practice for at least a 6-month period.
Other: My Life, My Healthcare Discussion Aid
The My Life, My Healthcare instrument is a conversational tool designed to help patients and clinicians discuss capacity in clinical conversations of primary care.
No Intervention: Control
Sites randomized to control will not be expected to implement the My Life, My Healthcare Discussion Aid in practice. They will be expected to practice chronic care as usual.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patient Assessment of Chronic Illness Care (PACIC)
Time Frame: 6 months
The 20-item scale measures goal setting, coordination of care, decision support, problem solving, and patient activation, and prompts the patient to reflect with items such as: "Over the past 6 months, when I received care for my chronic conditions, I was: helped to make a treatment plan that I could carry out in my daily life."
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Illness Intrusiveness Scale
Time Frame: 6 months
This identifies the extent to which the treatment regimen interferes with life by asking "How much does your illness and/or its treatment interfere with..." things like "your work, including job, house work, chores, or errands?"
6 months
General Self-Rated Health
Time Frame: 6 months
"In general, would you say your health is: Excellent, Very Good, Good, Fair, Poor?"
6 months
Communicate with Physician Self-Efficacy Subscale
Time Frame: 6 months
This 3-item scale has been used in work by Lorig et al. for chronic disease, and asks questions such as "How confident are you that you can discuss openly with your doctor any personal problems that may be related to your illness?"
6 months
Consultation Care Measure
Time Frame: 6 months
This 20-item scale is a valid and discriminating tool to measure communication and partnership, personal relationship, health promotion, positive and clear approach to the problem, and interest in effect of healthcare on patient's life within a single pat
6 months
Self-efficacy to Manage Disease in General Subscale
Time Frame: 6 months
asks questions such as "How confident are you that you can do all the things necessary to manage your condition on a regular basis?"
6 months
Treatment Burden Questionnaire (TBQ)
Time Frame: 6 months
The questionnaire measures the perceived burden of taking medications, self-monitoring and other self-management activities by asking participants to rate the impact of these tasks on a scale from 1-10 with items such as: "The taste, shape or size of your tablets and/or the annoyances caused by your injections (e.g., pain, bleeding, bruising or scars)."
6 months
Relational Coordination of Care Team
Time Frame: 6 months
assesses seven domains of coordinated teams: frequent, timely, accurate, and problem-solving communication, shared goals, shared knowledge, and mutual respect.
6 months
Care Team Assessment of Chronic Illness Care (ACIC)
Time Frame: 6 months
Measures clinician, coach, and clinical team satisfaction with care delivery.
6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gordon and Betty Moore Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kasey R. Boehmer, MPH, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-007340

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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