Skip to main content
OpenTrials
Completed

NCT Number: NCT03293914

Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach

This study is examining the feasibility of implementing an occupational therapy intervention addressing diabetes management in a primary care clinic within the Los Angeles County Department of Health Services (LAC-DHS), as well as the impact of this intervention approach on clinical outcomes, efficiency and patient-centeredness of care. This implementation science study is evaluating two emerging trends in healthcare delivery: (1) the integration of nontraditional providers into primary care medical home (PCMH) settings to facilitate the delivery of high-quality, comprehensive primary care while reducing the burden on physicians; and (2) the potential value of using occupational therapists to address chronic disease management in this setting

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LAC+USC Primary Care Adult West Clinic

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Current patient at Los Angeles County-USC Medical Center Adult West Primary Care clinic
  • Diagnosed diabetes (type 1 or type 2) documented in EMR
  • Most recent HbA1c level >9.0% OR has not had an HbA1c measurement within past 12 months
  • Per provider judgment, would be willing to make lifestyle changes related to diabetes self-care

Exclusion criteria

  • Active, untreated substance use or behavioral health disorder which interferes with participation in major life activities

Treatment and study plan

Lifestyle Redesign

Behavioral

Individualized lifestyle intervention incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants receive approximately 8 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the intervention protocol.

Other names: Resilient, Empowered, Active Living with Diabetes (REAL)

Primary outcomes

  1. Difference in the daily rate of change of Glycated hemoglobin (HbA1C) during the year prior to baseline, compared to the period from baseline to post-intervention

    Time frame: all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months)

    Measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C is measured periodically, as prescribed by study-independent provider.

Secondary outcomes

  1. Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) at post-intervention

    Time frame: Baseline, an average of 4 months

    19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning.

  2. Difference in the daily rate of change of Patient Health Questionnaire-9 (PHQ-9) during the year prior to baseline, compared to the period from baseline to post-intervention

    Time frame: all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months)

    9-item survey measure assessing severity of depressive symptoms. PHQ-9 is measured at each study-independent clinic visit for patients who screen positive on the PHQ-2 (score >2).

  3. Change from baseline in Summary of Diabetes Self-Care Activities (SDSCA) at post-intervention

    Time frame: Baseline, an average of 4 months

    14 items assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes.

  4. Change from baseline in Medication adherence scale at post-intervention

    Time frame: Baseline, an average of 4 months

    3-item self-report medication adherence scale designed by Ira B. Wilson, Yoojin Lee, Joanne Michaud, Floyd J. FowlerJr., and William H. Rogers

  5. Change from baseline in Appraisal of Diabetes Scale at post-intervention

    Time frame: Baseline, an average of 4 months

    7-item self-report scale assessing the individual's appraisal of his or her diabetes

  6. Change from baseline RAND 20-Item Short Form Survey (SF-20) at post-intervention

    Time frame: Baseline, an average of 4 months

    The SF-20 is a 20-item set of generic, coherent, and easily administered quality-of-life measures.

  7. Acceptability

    Time frame: Months 11-12

    Both formative and summative data will be gathered throughout the study to assess acceptability, defined herein as the perception of the intervention as agreeable/satisfactory. Acceptability will be assessed through interviews.

  8. Appropriateness

    Time frame: Months 0-2, 3-10, and 11-12

    Both formative and summative data will be gathered throughout the study to assess appropriateness, defined herein as the perceived relevance or compatibility of the intervention in the practice setting. Appropriateness will be assessed through interviews.

  9. Feasibility

    Time frame: Months 0-2, and 11-12

    Both formative and summative data will be gathered throughout the study to assess feasibility, defined herein as the extent to which the intervention can be successfully used in a practice setting. Feasibility will be assessed through surveys.

  10. Fidelity

    Time frame: Months 0-2, 3-10, and 11-12

    Both formative and summative data will be gathered throughout the study to assess fidelity, defined herein as the extent to which the intervention is implemented as intended. Fidelity will be assessed through score on fidelity checklist.

  11. Efficiency

    Time frame: Months 0-2 and 11-12

    Both formative and summative data will be gathered throughout the study to assess efficiency, defined herein as the degree to which providers work to the "top of license". Efficiency will be assessed through interviews.

  12. Timeliness

    Time frame: Months 11-12

    Both formative and summative data will be gathered throughout the study to assess timeliness, defined herein as the availability of appointments when needed. Timeliness will be assessed through staff documentation records.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Los Angeles County Department of Health Services (DHS)
  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 26, 2017
Registry last updated
Mar 24, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.