OT-Led Interdisciplinary Diabetes Self-Management Prgm
Occupational Therapy Led Interdisciplinary Diabetes Self-Management Program
1 other identifier
interventional
3
1 country
1
Brief Summary
This study proposes to introduce an outpatient Occupational Therapy (OT)-led diabetes intervention program. OTs with training in diabetes self-management modules that address physical, social, emotional, and systemic factors that influence health. Patients receiving outpatient OT services for development of diabetes self-management skills will be seen for approximately 8 forty five-minute to one-hour sessions over 6 months. OTs will communicate with other interdisciplinary care team members using Electronic Health Record (EHR) messaging, phone calls, and in-person communication as needed. There will be at minimum a monthly consult meeting with a doctor of psychology (Psy D), registered dietitian (RD), social worker (SW), and pharmacist (PharmD), and the primary care medical team will be provided with monthly progress notes. The investigators hypothesize that participants demonstrate improved blood sugar levels, improved ability to take medications as directed, increases in overall sense of physical, mental, and social health, and positive changes in their self-efficacy related to diabetes self-management. The investigators also hypothesize that OT visits will be reimbursed by insurers more than 50% of all billed visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Apr 2019
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedStudy Start
First participant enrolled
April 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2019
CompletedJune 9, 2020
June 1, 2020
4 months
January 24, 2019
June 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline Glycated hemoglobin (HbA1C)
Measure of blood glucose concentration over approximately the previous 12 weeks.
Baseline & 6 months.
Secondary Outcomes (4)
Canadian Occupational Therapy Measure (COPM)
Baseline & 6 months.
Change from Baseline Patient-Reported Outcomes Measurement Information SystemⓇ (PROMIS) 29
Baseline & 6 months.
Change from Baseline Diabetes Empowerment Scale (DES-SF)
Baseline & 6 months.
Change from Baseline Medication Adherence Assessment Scale
Baseline & 6 months.
Study Arms (1)
OT Diabetes Self-Management Intervention
EXPERIMENTALThe intervention is organized into five modules. Each participant receives an individually tailored combination of modules, and treatment activities within each module, as established through collaborative goal setting between the participant and OT during the initial evaluation. The five modules are: (1) Living with Diabetes-addressing gaps in the knowledge and skills necessary to effectively manage diabetes; (2) Access and Advocacy-strategies to collaborate and communicate with healthcare providers; (3) Activity and Health-analyzing daily habits and routines; (4) Social Support-strategies to address diabetes care in various social environments and to identify sources of support; (5) Emotional Well-Being-strategies to address stress, diabetes burnout, and depression.
Interventions
Occupational therapy chronic disease self-management intervention.
Eligibility Criteria
You may qualify if:
- Diagnosed with Diabetes Mellitus Type 2
- Most recent HbA1c level \>7.0% OR has been identified by medical provider as having uncontrolled diabetes
- English or Spanish Speaking
- Patient enrolled in a contracted commercial insurance plan or self-paying patients
- Expresses willingness to make lifestyle changes related to diabetes self-care
You may not qualify if:
- Patients that receive care through Workers Comp, or Motor Vehicle Insurance
- Patients that do not speak English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Arizona State Universitylead
- Hand Therapy Partnerscollaborator
Study Sites (1)
Hand Therapy Partners
Mesa, Arizona, 85298, United States
Related Publications (2)
Clark., F A, Blanchard., J, Sleight, A., Cogan, A., Florindez, L., Gleason, S.,…Vigen, C. (2015). Lifestyle redesign: The intervention tested in the USC well elderly studies (2nd ed.). AOTA Press: MD
BACKGROUNDPyatak EA, Carandang K, Vigen CLP, Blanchard J, Diaz J, Concha-Chavez A, Sequeira PA, Wood JR, Whittemore R, Spruijt-Metz D, Peters AL. Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Randomized Controlled Trial. Diabetes Care. 2018 Apr;41(4):696-704. doi: 10.2337/dc17-1634. Epub 2018 Jan 19.
PMID: 29351961BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sue Dahl-Popolizio, DBH, OTR/L
Arizona State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2019
First Posted
January 30, 2019
Study Start
April 11, 2019
Primary Completion
July 30, 2019
Study Completion
July 30, 2019
Last Updated
June 9, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share