Diabetes Self-Management Education With Sleep Hygiene

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Diabetes Self-Management Education With Sleep Hygiene

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04420845
• Other study ID #: 239740
• Status: Withdrawn
• Phase: N/A
• Start date: March 25, 2022
• Est. completion date: March 25, 2022

Study information

• Verified date: April 2022
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test whether adding sleep hygiene education and support to diabetes self-management education and support (DSMES) in diverse patients (African American, Hispanic, Pacific Islander, and Caucasian) with type 2 diabetes myelitis (T2DM) from rural UAMS Regional Programs clinics is more effective than DSMES alone. The specific aims for this study are:

• Aim 1A (Primary): Determine if this model improves blood glucose levels as measured by the HbA1c test in diverse adults with T2DM.

• Aim 1B: Determine the preliminary effectiveness of DSMES+SHES on sleep duration and sleep quality, blood pressure, fasting lipids, body mass index (BMI), self-management behavior, self-efficacy, diabetes-related distress, and diabetes-related quality of life in diverse adults with T2DM.

• Aim 2A: Determine the feasibility and acceptability of DSMES+ SHES when implemented with diverse adults with T2DM.

• Aim 2B: Determine the feasibility and acceptability of DSMES+ SHES implementation in Regional Programs clinics.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 25, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Diagnosed with type 2 diabetes

• Speak English

Exclusion Criteria:

• Received DSME in the past three years

• Have a condition that makes it unlikely they will be able to follow the protocol

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Sleep Hygiene

Intervention

Behavioral:
• Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES)
SHES outlines the importance of sleep for people with type 2 diabetes mellitus and provide practical information and guidance about sleep habits. Specifically, the focus will be on: avoiding consumption of caffeine, nicotine, alcohol; avoiding use of light emitting devices before bedtime; avoiding excessive intake of fluids or heavy meals before bedtime; promoting regulation of light, noise, and temperature in the bedroom; timing of and importance of exercise; maintaining consistent sleep and wake times; establishing a pre-bedtime routine; and managing stress.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences Northwest	Fayetteville	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean HbA1c (NGSP%) from baseline to 12 weeks post-intervention	A Siemens analyzer will be utilized to calculate HbA1c (%) for each participant at each time point. Changes in the primary outcome measure will be assessed from baseline to post-intervention.	Baseline and 12 weeks post-intervention
Secondary	Change in sleep duration from baseline to 12 weeks post-intervention	Self-reported sleep duration (hours slept) will be assessed using valid Behavioral Risk Factor Surveillance System survey items.	Baseline and 12 weeks post-intervention
Secondary	Change in sleep quality from baseline to 12 weeks post-intervention	The PROMIS® Short Form v1.0- Sleep Disturbance-4a scale will be used to assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep.This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep.	Baseline and 12 weeks post-intervention
Secondary	Change in mean blood pressure (systolic & diastolic, mmHg) from baseline to 12 weeks post-intervention	Blood pressure will be measured with a sphygmomanometer and stethoscope or digital blood pressure device with the participant seated and arm elevated.	Baseline and 12 weeks post-intervention
Secondary	Change in mean body mass index (BMI) from baseline to 12 weeks post-intervention	BMI will be collected by measuring participant height (without shoes) using a stadiometer, and by measuring participant weight (without shoes) using a calibrated digital scale. Participant weight and height will then be used to compute a continuous measure of BMI.	Baseline and 12 weeks post-intervention
Secondary	Change in mean total cholesterol (mg/dL) from baseline to 12 weeks post-intervention	Through finger prick blood collection, point of care tests will be used used to test total cholesterol using a commercial lipid panel kit and Cholestech LDX analyzer.	Baseline and 12 weeks post-intervention
Secondary	Change in mean low-density lipoproteins (LDL) (mg/dL) from baseline to 12 weeks post-intervention	Through finger prick blood collection, point of care tests will be used used to test LDL using a commercial lipid panel kit and Cholestech LDX analyzer.	Baseline and 12 weeks post-intervention
Secondary	Change in mean high-density lipoproteins (HDL) (mg/dL) from baseline to 12 weeks post-intervention	Through finger prick blood collection, point of care tests will be used used to test HDL using a commercial lipid panel kit and Cholestech LDX analyzer.	Baseline and 12 weeks post-intervention
Secondary	Change in mean triglycerides (mg/dL) from baseline to 12 weeks post-intervention	Through finger prick blood collection, point of care tests will be used used to test triglycerides using a commercial lipid panel kit and Cholestech LDX analyzer.	Baseline and 12 weeks post-intervention
Secondary	Change in diabetes self-management behaviors from baseline to 12 weeks post-intervention	The Summary of Diabetes Self-Care Activities (SDSCA) will be used to measure engagement in self-management activities. The SDSCA consists of 12 items to assess the self-reported frequency of performing diabetes self-care tasks, including testing blood sugar, following healthful eating plans, and exercising regularly.	Baseline and 12 weeks post-intervention
Secondary	Change in diabetes-related self-efficacy from baseline to 12 weeks post-intervention	The Diabetes Management Self-Efficacy Scale (DMSES) will be used to measure patient's confidence in managing their diabetes. The DMSES consists of 8 items to assess self-reported confidence in managing aspects of their diabetes. Items are scored on a 0-10 point scale, with higher scores indicating higher levels of self-efficacy.	Baseline and 12 weeks post-intervention
Secondary	Change in diabetes-related distress from baseline to 12 weeks post-intervention	The Problem Areas in Diabetes Scale (PAID)-5 will be used to measure diabetes distress. The PAID-5 consists of 5 items to assess self-reported diabetes-related emotional distress, including feeling scared or depressed. Items are scored on a 0-4 point scale, with higher scores indicating higher levels of distress.	Baseline and 12 weeks post-intervention
Secondary	Change in diabetes-related quality of life from baseline to 12 weeks post-intervention	The DAWN2 Impact of Diabetes Profile (DIDP) will be used to measure the perceived impact of diabetes on patients' quality of life. The DIDP consists of 6 items to assess self-reported impacts on quality of life, including physical health, financial situation, and relationships with others.	Baseline and 12 weeks post-intervention