Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach

NCT03293914 | Completed

• 2 other identifiers: SC CTSI Grant #UL1TR001855UL1TR001855
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus

Outcome Measures

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

  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 Outcomes (12)

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

  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

  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

  Baseline, an average of 4 months

• Change from baseline in Medication adherence scale at post-intervention

  Baseline, an average of 4 months

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

  Baseline, an average of 4 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care Control

NO INTERVENTION

Participants will not be contacted; outcome data will be extracted from medical records.

Interventions

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.

Also known as: Resilient, Empowered, Active Living with Diabetes (REAL)

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

LAC+USC Primary Care Adult West Clinic

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Elizabeth Pyatak, PhD, OTR/L

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an implementation trial being conducted in a real-world clinical setting in which masking is not appropriate.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 26, 2017
• Study Start: September 18, 2017
• Primary Completion: May 31, 2019
• Study Completion: November 30, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)