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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Lifestyle Redesign

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • LAC+USC Primary Care Adult West Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; Participants will be invited to enroll in an occupational therapy (OT) lifestyle redesign intervention focused on diabetes management. The intervention includes approximately 8 one-hour OT sessions over 4 months.	Behavioral: Lifestyle Redesign; 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)
NO_INTERVENTION: Usual Care Control; Participants will not be contacted; outcome data will be extracted from medical records.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C is measured periodically, as prescribed by study-independent provider.	all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) at post-intervention	19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning.	Baseline, an average of 4 months
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	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).	all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months)
Change from baseline in Summary of Diabetes Self-Care Activities (SDSCA) at post-intervention	14 items assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes.	Baseline, an average of 4 months
Change from baseline in Medication adherence scale at post-intervention	3-item self-report medication adherence scale designed by Ira B. Wilson, Yoojin Lee, Joanne Michaud, Floyd J. FowlerJr., and William H. Rogers	Baseline, an average of 4 months
Change from baseline in Appraisal of Diabetes Scale at post-intervention	7-item self-report scale assessing the individual's appraisal of his or her diabetes	Baseline, an average of 4 months
Change from baseline RAND 20-Item Short Form Survey (SF-20) at post-intervention	The SF-20 is a 20-item set of generic, coherent, and easily administered quality-of-life measures.	Baseline, an average of 4 months
Acceptability	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.	Months 11-12
Appropriateness	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.	Months 0-2, 3-10, and 11-12
Feasibility	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.	Months 0-2, and 11-12
Fidelity	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.	Months 0-2, 3-10, and 11-12
Efficiency	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.	Months 0-2 and 11-12
Timeliness	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.	Months 11-12

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Center for Advancing Translational Sciences (NCATS); Los Angeles County Department of Health Services (DHS)

Publications and helpful links

Helpful Links

• Summary of research study.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2017
• Primary Completion (ACTUAL): May 31, 2019
• Study Completion (ACTUAL): November 30, 2019

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 25, 2017
• First Posted (ACTUAL): September 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: SC CTSI Grant #UL1TR001855; UL1TR001855 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No