My Life, My Healthcare

Chronic Disease Clinical Trial

Official title:

My Life, My Healthcare

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017196
• Other study ID #: 16-007340
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: July 2019

Study information

• Verified date: June 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1929
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Vidant Multispecialty Clinic Belhaven	Belhaven	North Carolina
United States	CMC- Union Family Medicine	Charlotte	North Carolina
United States	Elizabeth Family Medicine	Charlotte	North Carolina
United States	Vidant Family Medicine Chocowinity	Chocowinity	North Carolina
United States	Primary Care Centers of East Kentucky	Hazard	Kentucky
United States	Mayo Clinic Health System La Crosse	La Crosse	Wisconsin
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Health System - Springfield	Springfield	Minnesota
United States	Lewis County Primary Care Center, Inc.	Vanceburg	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Gordon and Betty Moore Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Assessment of Chronic Illness Care (PACIC)	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	Illness Intrusiveness Scale	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
Secondary	General Self-Rated Health	"In general, would you say your health is: Excellent, Very Good, Good, Fair, Poor?"	6 months
Secondary	Communicate with Physician Self-Efficacy Subscale	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
Secondary	Consultation Care Measure	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
Secondary	Self-efficacy to Manage Disease in General Subscale	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
Secondary	Treatment Burden Questionnaire (TBQ)	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
Secondary	Relational Coordination of Care Team	assesses seven domains of coordinated teams: frequent, timely, accurate, and problem-solving communication, shared goals, shared knowledge, and mutual respect.	6 months
Secondary	Care Team Assessment of Chronic Illness Care (ACIC)	Measures clinician, coach, and clinical team satisfaction with care delivery.	6 months

External Links

•   Mayo Clinic Clinical Trials