Mindful Stress Reduction in Diabetes Self-management Education for Veterans (Mind-STRIDE)
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|ClinicalTrials.gov Identifier: NCT02928952|
Recruitment Status : Completed
First Posted : October 10, 2016
Results First Posted : May 28, 2021
Last Update Posted : May 28, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Behavioral: Mind-STRIDE||Not Applicable|
Background: One million Veterans (25%) who receive health care through Veterans Health Administration (VHA) have diabetes and are therefore responsible for daily diabetes self-management (DSM). DSM is essential for glycemic control and prevention of potentially life threatening and disabling complications such as severe hypoglycemia, kidney failure, acute coronary syndrome and stroke. Importantly, 40% of individuals with diabetes suffer from diabetes-related distress (DRD) that interferes with their ability to sustain healthy self-management behaviors, and may be particularly problematic for Veterans who are at higher risk for comorbid negative emotional states such as depression and post-traumatic stress disorder.
Diabetes self-management education (DSME) has traditionally contained little content or skill-building directly related to stress management, leaving this critical component of diabetes self-management largely unaddressed in DSME. In the investigators' pilot work, the investigators have developed a brief stress management intervention known as Mind-STRIDE, which contains mindfulness training and home practice and is easily integrated into existing DSME. While the investigators have previously demonstrated the feasibility, patient acceptability, and initial efficacy of Mind-STRIDE, its effects on diabetes-related psychological and physiological patient outcomes remain unknown. There is, therefore, a critical need to determine the efficacy of this targeted mindfulness intervention for improving DRD, diabetes self-efficacy, DSM behaviors, and metabolic control of Veterans with diabetes in order to offer comprehensive, evidence-based DSME that improves Veteran-centric diabetes outcomes.
Objectives: The objectives of this study are to determine the efficacy of Mind-STRIDE for improving DRD, diabetes self-efficacy, DSM, and metabolic control, and to characterize distinctive Veteran experiences with DRD and Mind-STRIDE.
Methods: To achieve these objectives, the investigators will conduct a randomized controlled trial of 126 Veterans at a large VA medical center in southwest PA. Participants will be assigned to one of two study conditions: an experimental group that receives routine diabetes education plus Mind-STRIDE, or to a usual care group that receives diabetes education alone. DRD, diabetes self-efficacy, and DSM will be assessed using self-report questionnaires. Metabolic control (Hemoglobin A1c) will be assessed using standard laboratory procedures. Data will be collected at baseline, 12-weeks, and 24-weeks, and will be analyzed using mixed-effects models. Telephone interviews will be conducted at 15-weeks post-intervention in a subset of participants from the experimental group, and will be analyzed using modified Grounded Theory methods. Quantitative and qualitative findings will be compared and interpreted using Convergent Parallel Design.
Status: Assessments were completed 4/09/2020.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effects of a Mindfulness Intervention Delivered Within Diabetes Education on Diabetes-related Outcomes in Military Veterans|
|Actual Study Start Date :||November 1, 2016|
|Actual Primary Completion Date :||April 9, 2020|
|Actual Study Completion Date :||April 9, 2020|
Experimental: Diabetes Self Management Education (DSME) + Mind-STRIDE
Will receive routine diabetes self-management education + the Mind-STRIDE intervention
Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education
No Intervention: DSME alone
Usual care control
- Problem Areas in Diabetes Scale (PAID) -(Measures Diabetes Distress) [ Time Frame: baseline, 12 weeks and 24 weeks ]A 20-item psychometrically validated self-report questionnaire on a 5 point Likert scale (0= not problem; 4= a serious problem). The scores are summed and multiplied by 1.25. Minimum value = 0; Maximum value = 100. Higher scores denote higher levels of diabetes related distress. The cutoff for significant distress is 33; a score of 40 is consistent with diabetes burn-out.
- Diabetes Self-efficacy Scale (DSES) [ Time Frame: baseline, 12 weeks and 24 weeks ]An 8-item psychometrically validated self-report questionnaire on a 10- point Likert Scale (1= Not confident at all; 10 = Totally confident). This scale measures diabetes self efficacy, a critical pathway to improved self-management that refers to an individual's confidence in their ability to perform key diabetes self-management behaviors. Scores are derived as the mean of the 8 questions. Minimum score =1; Maximum Score = 10. Higher scores denote higher diabetes self-efficacy.
- Hemoglobin A1c (A1C) [ Time Frame: baseline, 12 weeks and 24 weeks ]A blood test that measures the percentage of glycated hemoglobin in red blood cells as a means of estimating the average blood sugar concentrations for the preceding two to three months. Lower percentage denote better blood glucose levels and may range from 4.5% in persons without diabetes t0 >15% in persons with poorly managed hyperglycemia. . An A1C <7% has been associated with prevention of diabetes complications. A1C>9% denotes chronic,severe blood glucose elevation. All tests were performed at VAPHS according to National Glyco-hemoglobin Standardization Program-approved methods.
- Mindfulness Attention and Awareness Scale (MAAS) [ Time Frame: baseline, 12 weeks and 24 weeks ]A 15-item psychometrically validated questionnaire on a 6-point Likert scale (1=Almost Always and 6= Never) The scale is scored by computing the mean of the 15 items. (Minimum score = 1; maximum score = 6). Higher scores reflect higher levels of dispositional (trait) mindfulness. Average score in the general US population is 4.22. Mindfulness is a mental state achieved by focusing one's awareness on the present moment, while calmly acknowledging and accepting one's feelings, thoughts, and bodily sensations.
- Body Weight [ Time Frame: baseline, 12 weeks and 24 weeks ]Weight in pounds
- Blood Pressure [ Time Frame: baseline, 12 weeks and 24 weeks ]Change in mean arterial blood pressure, calculated as blood pressure + 2 (diastolic blood pressure) divided by 3.
- Patient Health Questionnaire (PHQ8) [ Time Frame: baseline, 12 weeks and 24 weeks ]The Patient Health Questionnaire (PHQ-8) is a standardized, validated scale that assesses 8 key symptoms of depression experienced over the prior two weeks on a 4-point Likert scale (0=not at all; 3= nearly every day). It is the same as the PHQ-9, without the question regarding suicidal ideation. Score is the sum of the 8 items (Minimum value =0; Maximum= 24). A score of 10 or greater is considered major depression, 20 or more is severe major depression.
- PTSD Checklist- Civilian Version (PCL-C) [ Time Frame: baseline, 12 weeks and 24 weeks ]The Abbreviated PCL-C is a validated 6-item civilian version of the PTSD check- list designed for use in general medical settings to assess symptoms of PTSD using a 5-point Likert scale. Scores reflect how much the participant has been bothered by specific PTSD symptoms during the past month. (0= "not at all; 4= "extremely") .Scores are summed. (Minimum value =0; maximum values = 24). Scores >14 are suggestive of PTSD, with higher scores reflecting greater PTSD symptoms.
- Summary of Diabetes Self-Care Activities (SDSCA), General Diet [ Time Frame: baseline, 12 weeks and 24 weeks ]A 2-item subscale of the psychometrically validated SDSCA that measures the frequency of general dietary behaviors each day over the past 7-days and number of days per week over the past month (0= no days; 7 = 7 days). Scores = mean number of days per week ( Minimum score =0; maximum score = 7) . Higher scores denote healthier dietary behaviors.
- Summary of Diabetes Self-Care Activities (SDSCA), Specific Diet [ Time Frame: baseline, 12 weeks and 24 weeks ]
A 2-item subscale of the psychometrically validated SDSCA that measures the frequency of eating fruits and vegetables and high fat foods each day over the past 7-days. Minimum maximum values = (0= no days; 7 = 7 days). 1 item is scored as mean number of days (Minimum score =0; maximum score = 7), while the 2nd item is summed and reversed (0= 7days; 7= 0 days). The scores for the two items are summed for the subscale score (Minimum score=0; maximum score =7) Higher scores denote healthier dietary behaviors.
Each subscale of the SDSCA is scored separately, without a calculated composite score.
- Summary of Diabetes Self-Care Activities (SDSCA) Space Carbohydrates [ Time Frame: baseline, 12 weeks and 24 weeks ]One item from the SDSCA that assesses the number of days over the past 7-days in which the participant spaced carbohydrates evenly throughout the day. Minimum score 0; maximum score 7. Higher scores denote healthier dietary behaviors.
- Summary of Diabetes Self-Care Activities (SDSCA)- Exercise [ Time Frame: baseline, 12 weeks, 24 weeks ]
A 2-item subscale of the SDSCA that measures the number of days over the past 7-days on which the participant engaged in physical activity . Score = mean score of days over the past 7 days (Min.=1; Max.=7). Higher scores denote healthier exercise behaviors.
Each SDSCA subscale scored separately.
- Summary of Diabetes Self-Care Activities (SDSCA)- - Footcare [ Time Frame: baseline, 12 weeks, 24 weeks ]A 2-item subscale of the SDSCA that measures the number of days the participant 1) inspected their feet and 2) inspected the inside of their shoes over the past 7-days. Score = mean number of days (Min=0; max=7). Higher scores denote healthier footcare behaviors.
- Summary of Diabetes Self-Care Activities (SDSCA)- Blood Glucose Testing [ Time Frame: baseline, 12 weeks, 24 weeks ]
A 2-item subscale of the SDSCA that measures 1) the number of days on which the participant tested their blood glucose over the past 7 days and 2) the number of days on which they tested their blood glucose according to the number of times recommended by their health care provider over the past 7-days. Scores= mean number of days per week. Minimum score is 0 Maximum score is 7.Higher scores denote healthier self-monitoring behaviors.
Each SDSCA subscale scored separately
- Summary of Diabetes Self-Care Activities (SDSCA)- - Smoking [ Time Frame: baseline,12 weeks, 24 weeks ]A 2-item subscale of the SDSCA that measures 1) whether the participant smoked even a puff of a cigarette in the past 7 days (0=no; 1= yes) and 2) if so, the number of cigarettes smoked on an average day. The scores are summed. Minimum score =0, maximum score = >40. Lower scores denote healthier smoking behaviors.
- Summary of Diabetes Self-Care Activities (SDSCA)- - Medication Adherence [ Time Frame: baseline, 12 weeks, 24 weeks ]
A 2-item subscale of the SDCSA that measures the frequency of 1) taking prescribed insulin and 2)prescribed number of diabetes pills each day over the past 7-days. Scores from the 2 items are summed. Minimum score =0; maximum score = 7). Higher scores denote greater adherence to diabetes medications. Participants entered N/A if they were not prescribed insulin or diabetes pills.
Each subscale of the SDSCA is scored independently with no calculated composite score.
- Change in 6-item PROMIS Short Form v1.0 Pain Interference 6 b [ Time Frame: baseline, 12 weeks and 24 weeks ]A psychometrically validated 7-item instrument on a 5 point Likert scale (1= "not at all"- 5 and "very much") determining the degree to which pain has interfered with aspects of daily living during the past 7 days. It is a general and not disease-specific measure of pain. Scores are summed (Min. value = 6; Max value =35). Total raw scores are then converted into a T-score for each participant. The T-scores rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10. A score of 50 is the average for the United States general population with a standard deviation of 10.
- Insomnia Severity Index (ISI) [ Time Frame: baseline, 12 weeks and 24 weeks ]Seven psychometrically tested items on a 4 point Likert scale that measure difficulty falling asleep and staying asleep (0= none; 4=very severe) and satisfaction with current sleep patterns (0=very satisfied; 4=very dissatisfied), Noticeable impairment of quality of life (0= not noticeable; 4= very much noticeable), Worry/distress re: sleep (0=not at all worried; 4=very much worried); Interference of sleep problem to daily functioning (0=not interfering; 4= very much interfering). Scores are summed. Minimum score = 0; maximum score = 20). Higher scores denote greater insomnia severity. Scores over 14 denote insomnia; Scores 8 to 14 denote subthreshold insomnia.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Referral to DSME class at VA Pittsburgh Healthcare System University Drive Campus (VAPHS UD)
- Diagnosis of type 1 or type 2 diabetes
- Hemoglobin A1C >7.0%
- Problem Areas in "Diabetes Scale (PAID) -5" score =/ >3 or "Diabetes Distress Scale -2" =/>2 score indicating the presence of Diabetes-related Distress
- Documented cognitive impairment that would interfere with the ability to comprehend the informed consent and actively participate in the study
- Previous attendance of VA DSME class within the past 12 months
- Currently active mindfulness practice
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): NCT02928952
|United States, Pennsylvania|
|VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA|
|Pittsburgh, Pennsylvania, United States, 15240|
|Principal Investigator:||Monica M. DiNardo, PhD ARNP CDE||VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA|
Documents provided by VA Office of Research and Development:
|Responsible Party:||VA Office of Research and Development|
|Other Study ID Numbers:||
|First Posted:||October 10, 2016 Key Record Dates|
|Results First Posted:||May 28, 2021|
|Last Update Posted:||May 28, 2021|
|Last Verified:||May 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||There are currently no plans to share Individual Participant Data (IPD).|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Glucose Metabolism Disorders
Endocrine System Diseases