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OpenTrials
Completed

NCT Number: NCT03017196

My Life, My Healthcare

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Care Centers of East Kentucky, Hazard, Kentucky, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

My Life, My Healthcare Discussion Aid

Other

The My Life, My Healthcare instrument is a conversational tool designed to help patients and clinicians discuss capacity in clinical conversations of primary care.

Primary outcomes

  1. 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."

Secondary outcomes

  1. 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?"

  2. General Self-Rated Health

    Time frame: 6 months

    "In general, would you say your health is: Excellent, Very Good, Good, Fair, Poor?"

  3. 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?"

  4. 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

  5. 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. 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)."

  7. 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.

  8. Care Team Assessment of Chronic Illness Care (ACIC)

    Time frame: 6 months

    Measures clinician, coach, and clinical team satisfaction with care delivery.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Gordon and Betty Moore Foundation

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 11, 2017
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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