Diabetes Mellitus, Type 2NCT04420845
Diabetes Self-Management Education with Sleep Hygiene
A study testing Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES) in people with Diabetes Mellitus, Type 2 and Sleep Hygiene, run by University of Arkansas at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Sleep Hygiene
- What is being tested?
- Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2022to 25 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosed with type 2 diabetes
- Speak English
Who cannot join
- Received DSME in the past three years
- Have a condition that makes it unlikely they will be able to follow the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences Northwest
Fayetteville, Arkansas, 72703
About this study
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.
- Conditions
- Diabetes Mellitus, Type 2, Sleep Hygiene
- Being tested
- Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES)
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Not described Receives: Behavioral: Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks post-intervention
Secondary outcomes (12)
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.
Measured: Baseline and 12 weeks post-intervention
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.
Measured: Baseline and 12 weeks post-intervention
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.
Measured: Baseline and 12 weeks post-intervention
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.
Measured: Baseline and 12 weeks post-intervention
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.
Measured: Baseline and 12 weeks post-intervention
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.
Measured: Baseline and 12 weeks post-intervention
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.
Measured: Baseline and 12 weeks post-intervention
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.
Measured: Baseline and 12 weeks post-intervention
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.
Measured: Baseline and 12 weeks post-intervention
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.
Measured: Baseline and 12 weeks post-intervention
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.
Measured: Baseline and 12 weeks post-intervention
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.
Measured: Baseline and 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start25 Mar 2022
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Why it stopped: The study was significantly delayed due to the COVID-19 pandemic. The PI has chosen not to conduct the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420845
- Sponsor's protocol ID
- 239740
- Status last verified
- Apr 2022
- First submitted
- 28 May 2020
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Self-Management Education with Sleep Hygiene
- ClinicalTrials.gov ID
- NCT04420845
- Acronym / sponsor ID
- 239740
- Conditions
- Diabetes Mellitus, Type 2, Sleep Hygiene
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was significantly delayed due to the COVID-19 pandemic. The PI has chosen not to conduct the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Diagnosed with type 2 diabetes
- Speak English
Key exclusion criteria (2 listed)
- Received DSME in the past three years
- Have a condition that makes it unlikely they will be able to follow the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
Primary outcome
Change in mean HbA1c (NGSP%) from baseline to 12 weeks post-intervention
Time frame: Baseline and 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.
12 secondary outcomes
Change in sleep duration from baseline to 12 weeks post-intervention
Time frame: Baseline and 12 weeks post-intervention
Change in sleep quality from baseline to 12 weeks post-intervention
Time frame: Baseline and 12 weeks post-intervention
Change in mean blood pressure (systolic & diastolic, mmHg) from baseline to 12 weeks post-intervention
Time frame: Baseline and 12 weeks post-intervention
Change in mean body mass index (BMI) from baseline to 12 weeks post-intervention
Time frame: Baseline and 12 weeks post-intervention
Change in mean total cholesterol (mg/dL) from baseline to 12 weeks post-intervention
Time frame: Baseline and 12 weeks post-intervention
Change in mean low-density lipoproteins (LDL) (mg/dL) from baseline to 12 weeks post-intervention
Time frame: Baseline and 12 weeks post-intervention
Change in mean high-density lipoproteins (HDL) (mg/dL) from baseline to 12 weeks post-intervention
Time frame: Baseline and 12 weeks post-intervention
Change in mean triglycerides (mg/dL) from baseline to 12 weeks post-intervention
Time frame: Baseline and 12 weeks post-intervention
Change in diabetes self-management behaviors from baseline to 12 weeks post-intervention
Time frame: Baseline and 12 weeks post-intervention
Change in diabetes-related self-efficacy from baseline to 12 weeks post-intervention
Time frame: Baseline and 12 weeks post-intervention
Change in diabetes-related distress from baseline to 12 weeks post-intervention
Time frame: Baseline and 12 weeks post-intervention
Change in diabetes-related quality of life from baseline to 12 weeks post-intervention
Time frame: Baseline and 12 weeks post-intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES) in people with Diabetes Mellitus, Type 2 and Sleep Hygiene, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean HbA1c (NGSP%) from baseline to 12 weeks post-intervention (time frame: Baseline and 12 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.