Clinical trial NCT03293914: Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach
Official title: Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Los Angeles County Department of Health Services (DHS)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2017-09-26
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months)
Secondary outcomes:
measure: Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) at post-intervention
timeFrame: Baseline, an average of 4 months
measure: 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
timeFrame: all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months)
measure: Change from baseline in Summary of Diabetes Self-Care Activities (SDSCA) at post-intervention
timeFrame: Baseline, an average of 4 months
measure: Change from baseline in Medication adherence scale at post-intervention
timeFrame: Baseline, an average of 4 months
measure: Change from baseline in Appraisal of Diabetes Scale at post-intervention
timeFrame: Baseline, an average of 4 months
measure: Change from baseline RAND 20-Item Short Form Survey (SF-20) at post-intervention
timeFrame: Baseline, an average of 4 months
measure: Acceptability
timeFrame: Months 11-12
measure: Appropriateness
timeFrame: Months 0-2, 3-10, and 11-12
measure: Feasibility
timeFrame: Months 0-2, and 11-12
measure: Fidelity
timeFrame: Months 0-2, 3-10, and 11-12
measure: Efficiency
timeFrame: Months 0-2 and 11-12
measure: Timeliness
timeFrame: Months 11-12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LAC+USC Primary Care Adult West Clinic
state: California
Study officials:
affiliation: University of Southern California
name: Elizabeth Pyatak, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: