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Diabetes Self-Management Education With Sleep Hygiene

Primary Purpose

Diabetes Mellitus, Type 2, Sleep Hygiene

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES)
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences Northwest

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 28, 2020
Last Updated
April 19, 2022
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT04420845
Brief Title
Diabetes Self-Management Education With Sleep Hygiene
Official Title
Diabetes Self-Management Education With Sleep Hygiene
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The study was significantly delayed due to the COVID-19 pandemic. The PI has chosen not to conduct the study.
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
March 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Sleep Hygiene

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean HbA1c (NGSP%) from baseline to 12 weeks post-intervention
Description
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.
Time Frame
Baseline and 12 weeks post-intervention
Secondary Outcome Measure Information:
Title
Change in sleep duration from baseline to 12 weeks post-intervention
Description
Self-reported sleep duration (hours slept) will be assessed using valid Behavioral Risk Factor Surveillance System survey items.
Time Frame
Baseline and 12 weeks post-intervention
Title
Change in sleep quality from baseline to 12 weeks post-intervention
Description
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.
Time Frame
Baseline and 12 weeks post-intervention
Title
Change in mean blood pressure (systolic & diastolic, mmHg) from baseline to 12 weeks post-intervention
Description
Blood pressure will be measured with a sphygmomanometer and stethoscope or digital blood pressure device with the participant seated and arm elevated.
Time Frame
Baseline and 12 weeks post-intervention
Title
Change in mean body mass index (BMI) from baseline to 12 weeks post-intervention
Description
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.
Time Frame
Baseline and 12 weeks post-intervention
Title
Change in mean total cholesterol (mg/dL) from baseline to 12 weeks post-intervention
Description
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.
Time Frame
Baseline and 12 weeks post-intervention
Title
Change in mean low-density lipoproteins (LDL) (mg/dL) from baseline to 12 weeks post-intervention
Description
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.
Time Frame
Baseline and 12 weeks post-intervention
Title
Change in mean high-density lipoproteins (HDL) (mg/dL) from baseline to 12 weeks post-intervention
Description
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.
Time Frame
Baseline and 12 weeks post-intervention
Title
Change in mean triglycerides (mg/dL) from baseline to 12 weeks post-intervention
Description
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.
Time Frame
Baseline and 12 weeks post-intervention
Title
Change in diabetes self-management behaviors from baseline to 12 weeks post-intervention
Description
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.
Time Frame
Baseline and 12 weeks post-intervention
Title
Change in diabetes-related self-efficacy from baseline to 12 weeks post-intervention
Description
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.
Time Frame
Baseline and 12 weeks post-intervention
Title
Change in diabetes-related distress from baseline to 12 weeks post-intervention
Description
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.
Time Frame
Baseline and 12 weeks post-intervention
Title
Change in diabetes-related quality of life from baseline to 12 weeks post-intervention
Description
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.
Time Frame
Baseline and 12 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Arkansas for Medical Sciences Northwest
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Diabetes Self-Management Education With Sleep Hygiene

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