Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach
NCT ID: NCT03293914
Last Updated: 2020-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
143 participants
INTERVENTIONAL
2017-09-18
2019-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Acceptance and Commitment Therapy Principles for Diabetes Prevention
NCT05260983
OT-Led Interdisciplinary Diabetes Self-Management Prgm
NCT03821662
Community Health Workers and Diabetes Education
NCT02811874
Improving Diabetes Care With Patient Decision Aids - A Trial in Community-based Primary Care
NCT00668590
Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes
NCT07196007
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Usual Care Control
Participants will not be contacted; outcome data will be extracted from medical records.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Los Angeles County Department of Health Services (DHS)
UNKNOWN
National Center for Advancing Translational Sciences (NCATS)
NIH
University of Southern California
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Beth Pyatak
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elizabeth Pyatak, PhD, OTR/L
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
LAC+USC Primary Care Adult West Clinic
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SC CTSI Grant #UL1TR001855
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.