Diabetes Self-Management Plus Tai Chi Easy

Type 2 Diabetes Mellitus Clinical Trial

Official title:

An Integrative Online Diabetes Self-Management Education and Support Intervention Featuring Tai Chi Easy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180655
• Other study ID #: STUDY00003577
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: University of Arizona
• Contact: Ruth Taylor-Piliae, PhD, RN, FAHA, FAAN
• Phone: 520-626-4881
• Email: rpiliae[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to increase access to diabetes care and education for adults aged 40-64 years old who are diagnosed with Type 2 Diabetes Mellitus and are unable to attend education and support classes due to their work situation. This project will use an established, well-known program for Diabetes Self-Management Education and Support (DSMES) and combine it with Tai Chi Easy (TCE)™ to enhance physical health, psychological health, and health behaviors. Participants will be asked to attend 45 minutes of DSMES and 45 min of TCE twice a week for 6 weeks. All classes will be recorded and available online and can viewed at a time when it is most convenient to accommodate working adults. Participants will be asked to complete survey questionnaires online, at the beginning and end of the program; and have a smart phone to connect with a smart ring during the 6-week DSMES+TCE program. After the program is done, participants will be asked to return the smart ring. Upon receipt of the smart ring, they will receive a give a gift card to thank them for their participation in the program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 64 Years

Eligibility

Inclusion Criteria:

• diagnosed with T2DM
• any sex/gender
• any race/ethnicity
• any socioeconomic group
• has a smartphone
• receives care in a Federally Qualified Healthcare Center in Southern Arizona

Exclusion Criteria:

• Individuals with T1DM
• Individuals with gestational DM
• Individuals with pre-diabetes
• children
• pregnant women
• Individuals unable to provide informed consent
• Individuals with other serious co-occurring health condition (e.g., active cancer treatment)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Diabetes Self-Management Education and Support (DSMES) plus Tai Chi Easy (TCE)™
Participants will be asked to attend 45 minutes of DSMES and 45 min of TCE twice a week for 6 weeks. All classes will be recorded and available online and can viewed at a time when it is most convenient to accommodate working adults.

Locations

Country	Name	City	State
United States	University of Arizona College of Nursing	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Feasibility: Recruitment	the proportion of respondents who remained interested in the study after information and screening. Goal: recruit 10 participants per month for 3 months.	screening pre-intervention
Primary	Study Feasibility: Retention	number of participants that completed all aspects of the study (data collection pre-post intervention and study intervention) Goal: 80% study retention	pre and post intervention at 6-weeks
Primary	Study Feasibility: Intervention acceptability	The Acceptability of Intervention Measure (AIM) is brief and contains 4-items using a 5-point Likert scale (possible scores 4-20), with higher scores indicating greater acceptability of the intervention. Adequate reliability and validity have been reported. Benchmark: at least 75% intervention acceptability, across sites.	post-intervention at 6-weeks
Primary	Study Feasibility: Intervention feasibility	The Feasibility of Intervention Measure (FIM) is brief and contains 4-items using a 5-point Likert scale (possible scores 4-20), with higher scores indicating greater feasibility of the intervention. Adequate reliability and validity have been reported. Benchmark: at least 75% intervention feasibility, across sites.	post-intervention at 6-weeks
Primary	Study Feasibility: Intervention appropriateness	The Intervention Appropriateness Measure (IAM) is brief and contains 4-items using a 5-point Likert scale (possible scores 4-20), with higher scores indicating greater appropriateness of the intervention. Adequate reliability and validity have been reported. Benchmark: at least 75% intervention appropriateness, across sites.	post-intervention at 6-weeks
Primary	Study Feasibility: Intervention safety	number of adverse events during the intervention. Goal: no safety issues or adverse events	during the 6-week intervention
Secondary	self-reported physical health: Weight	body weight in pounds	pre-intervention (self-report)
Secondary	self-reported physical health: Height	body height in inches	pre-intervention (self-report)
Secondary	self-reported physical health: Waist Circumference	waist circumference in inches	pre-intervention (self-report)
Secondary	self-reported physical health: Blood Pressure	blood pressure in millimeters of mercury (mm/Hg)	pre-intervention (self-report)
Secondary	self-reported physical health: Blood Sugar	blood sugar in milligrams per deciliter (mg/dL)	pre-intervention (self-report)
Secondary	self-reported physical health: Hemoglobin A1C	percentage of hemoglobin in blood that is coated with glucose	pre-intervention (self-report)
Secondary	perceived psychological health: Diabetes Distress Scale	The Diabetes Distress Scale (DSS-17) is a widely used, self-administered scale. The DDS-17 contains 17 items and asks a person about living with diabetes, using a six-point Likert format (1=not a problem, 6=a very serious problem). The DDS-17 contains questions related to emotional burden, physician distress, regimen distress and interpersonal distress. Possible scores range from 17 to 102, with higher scores indicating greater diabetes distress.	pre and post-intervention at 6-weeks
Secondary	perceived psychological health: Patient Health Questionnaire-9	The Patient Health Questionnaire-9 (PHQ-9) is a widely used, self-administered scale to screen for depressive symptoms. The PHQ-9 contains 9 items that ask a person about problems that have been bothering them during the past 2 weeks, using a four-point Likert format (0=not at all, 3=nearly every day). Possible scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms.	pre and post-intervention at 6-weeks
Secondary	perceived psychological health: Posttraumatic Stress Scale-Civilian Version	The Posttraumatic Stress Scale-Civilian Version (PCL-C) is a self-administered scale that asks a person about problems or stressful life experiences during the past month. The PCL-C contains 17 items using a five-point Likert format (1=not at all, 5=extremely). Possible scores range from 17 to 85, with higher scores indicating greater symptoms associated with posttraumatic stress.	pre and post-intervention at 6-weeks
Secondary	perceived psychological health: Diabetes Quality of Life Questionnaire	The Diabetes Quality of Life Questionnaire (DQOL) is a self-administered scale that asks a person about their diabetes-related satisfaction, impact and worry. The DQOL contains 64 items using a using a five-point Likert format (satisfaction 1=very satisfied, 5=very dissatisfied; impact 1= no impact, 5=always impacted; worry 1=never worried, 5=always worried). Possible scores range from 64 to 320, with higher scores indicating worse quality of life.	pre and post-intervention at 6-weeks
Secondary	perceived psychological health: Perceived Stress Scale	The Perceived Stress Scale (PSS-10) is a widely used, self-administered scale. The PSS-10 contains 10 items and asks a person about situations they may have experienced in the past month as being unpredictable, uncontrollable, and overloaded using a five-point Likert format (0=never, 4=very often). Possible scores range from 0 to 40, with higher scores indicating greater perceived stress.	pre and post-intervention at 6-weeks
Secondary	health behaviors: Dietary Screener Questionnaire	The Dietary Screener Questionnaire (DSQ) is a 26-item self-administered scale that asks about the frequency of consumption of selected foods and drinks in the past month. The DSQ captures intakes of fruits and vegetables, dairy/calcium, added sugars, whole grains/fiber, red meat, and processed meat. The DSQ uses a scoring algorithm to convert responses to estimates of dietary intake for fruits and vegetables (cup equivalents), dairy (cup equivalents), added sugars (tsp), whole grains (ounce equivalents), fiber (g), and calcium (mg). Responses to the red meat and processed meat questions are as qualitative indicators of intake frequency, but no scoring algorithms were developed for those particular dietary factors.	pre and post-intervention at 6-weeks
Secondary	health behaviors: Rapid Assessment of Physical Activity	The Rapid Assessment of Physical Activity (RAPA) questionnaire is a widely used, self-administered scale to assess a person's engagement in physical activity during the week. The RAPA contains 9 yes/no questions. The first 7 questions assess weekly physical activity during free time (RAPA 1). Affirmative responses are reviewed to determine the person's level of physical activity during the week (1=sedentary, 7=active). Possible scores range from 1 to 7, with higher scores indicating greater the level and intensity of the physical activity. The last two questions include strength training and flexibility items (RAPA 2), which are scored separately (0=none, 1=strength training, 2=flexibility, 3=both). Possible scores range from 0 to 3, which indicate if the person is engaging in strength and flexibility exercise during the week.	pre and post-intervention at 6-weeks
Secondary	Objective measures using an Oura Ring: Sleep	Daily total sleep in hours and minutes	during the 6-week intervention
Secondary	Objective measures using an Oura Ring: Physical Activity	Daily total physical activity in number of steps	during the 6-week intervention
Secondary	Objective measures using an Oura Ring: Heart Rate Variability	Daily average heart rate variability during the night in milliseconds	during the 6-week intervention