OT-Led Interdisciplinary Diabetes Self-Management Prgm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03821662
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : February 1, 2019
Hand Therapy Partners
Information provided by (Responsible Party):
Arizona State University

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Diabetes Mellitus Behavioral: OT Diabetes Self-Management Intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Occupational Therapy Led Interdisciplinary Diabetes Self-Management Program
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: OT Diabetes Self-Management Intervention
The 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.
Behavioral: OT Diabetes Self-Management Intervention
Occupational therapy chronic disease self-management intervention.

Primary Outcome Measures :
  1. Change from Baseline Glycated hemoglobin (HbA1C) [ Time Frame: Baseline & 6 months. ]
    Measure of blood glucose concentration over approximately the previous 12 weeks.

Secondary Outcome Measures :
  1. Canadian Occupational Therapy Measure (COPM) [ Time Frame: Baseline & 6 months. ]
    The Canadian Occupational Performance Measure is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time. Areas of everyday living explored during the interview include self-care, productivity or leisure. The client is asked to rate the importance of each of the occupations to his/her life using a 10-point rating scale. Once the top five most important occupations are identified, the client is asked to use a 10 point scale to rate their own level of performance and satisfaction with performance for each of the five identified problems. The therapist calculates an average COPM performance score and satisfaction score. These typically range between 1 and 10, where 1 indicates poor performance and low satisfaction, respectively, while 10 indicates very good performance and high satisfaction.

  2. Change from Baseline Patient-Reported Outcomes Measurement Information SystemⓇ (PROMIS) 29 [ Time Frame: Baseline & 6 months. ]
    29-item quality of life survey of self-reported physical, mental and social health and wellbeing. The seven 4-item subscales are comprised of 5-point Likert Scale questions. The subscales can be administered together or individually. There is also one 11-point rating scale for pain intensity. The total raw score is the sum the values of the response to each question. For the 4-item subscales the range of raw scores is 4-20. T-scores can be calculated by the PROMIScore computer program with our without missing responses.

  3. Change from Baseline Diabetes Empowerment Scale (DES-SF) [ Time Frame: Baseline & 6 months. ]
    8-item measure of the psychosocial self-efficacy of people with diabetes. An item checked "strongly agree" receives 5 points; "agree" - 4 points; "neutral" - 3 points; "disagree" - 2 points; and "strongly disagree" receives 1 point. The numerical values for a set of items in a particular subscale (for example: items 5-14 in the "Goal Setting" subscale) are added and the total is divided by the number of items (in this case 10) in the subscale. The resulting value is the score for that subscale. An overall score for the DES can be calculated by adding all of the item scores and dividing by 28.

  4. Change from Baseline Medication Adherence Assessment Scale [ Time Frame: Baseline & 6 months. ]
    A 7-item survey of self-reported medication adherence. Total raw score is the sum of all likert scale items ranging from 0-28 total points. Lower scores indicate better adherence than higher scores. A score of zero indicates good adherence for self-management. Scores greater than 2 for any item indicate the need for intervention to address barriers to medication adherence.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients that receive care through Workers Comp, or Motor Vehicle Insurance
  • Patients that do not speak English or Spanish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03821662

Contact: Miranda Materi, OTD 480-565-2276
Contact: Sue Dahl-Popolizio, DBH, OTR/L 602-496-1733

United States, Arizona
Hand Therapy Partners Recruiting
Mesa, Arizona, United States, 85298
Contact: Miranda Materi, OTD         
Sponsors and Collaborators
Arizona State University
Hand Therapy Partners
Principal Investigator: Sue Dahl-Popolizio, DBH, OTR/L Arizona State University

Responsible Party: Arizona State University Identifier: NCT03821662     History of Changes
Other Study ID Numbers: 00009334
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arizona State University:
Occupational Therapy
Interdisciplinary Teams
Diabetes Self-Management

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases