OT-Led Interdisciplinary Diabetes Self-Management Prgm
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|ClinicalTrials.gov Identifier: NCT03821662|
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : February 1, 2019
|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)|
|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|
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.
- Change from Baseline Glycated hemoglobin (HbA1C) [ Time Frame: Baseline & 6 months. ]Measure of blood glucose concentration over approximately the previous 12 weeks.
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03821662
|Contact: Miranda Materi, OTDfirstname.lastname@example.org|
|Contact: Sue Dahl-Popolizio, DBH, OTR/Lemail@example.com|
|United States, Arizona|
|Hand Therapy Partners||Recruiting|
|Mesa, Arizona, United States, 85298|
|Contact: Miranda Materi, OTD|
|Principal Investigator:||Sue Dahl-Popolizio, DBH, OTR/L||Arizona State University|