Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach

Diabetes Mellitus Clinical Trial

Official title:

Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293914
• Other study ID #: SC CTSI Grant #UL1TR001855
• Secondary ID: UL1TR001855
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: March 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: November 30, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	LAC+USC Primary Care Adult West Clinic	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	Los Angeles County Department of Health Services (DHS), National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Summary of research study.