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Mindful Stress Reduction in Diabetes Self-management Education for Veterans (Mind-STRIDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02928952
Recruitment Status : Active, not recruiting
First Posted : October 10, 2016
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The purpose of this study is to see if adding Mindfulness training to diabetes education reduces feelings of stress and makes it easier to adhere to healthy behaviors that improve diabetes outcomes (such as hemoglobin A1c).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Mind-STRIDE Not Applicable

Detailed Description:

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: Recruitment is ongoing as of fall 2016.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
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 30, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Diabetes Self Management Education (DSME) + Mind-STRIDE
Will receive routine diabetes self-management education + the Mind-STRIDE intervention
Behavioral: Mind-STRIDE
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



Primary Outcome Measures :
  1. Change in Problem Areas in Diabetes Scale (PAID) -(measures diabetes-related distress) at 3 and 6 months [ Time Frame: baseline, 3 months, and 6 months ]
    A 20-item psychometrically validated self-report questionnaire on a 5 point Likert scale. Higher scores denote higher levels of diabetes related distress. PAID will be administered at 3 times point: baseline, 3 months and 6 months.


Secondary Outcome Measures :
  1. Change in Diabetes Self-efficacy Scale (DSES) at 3 months and 6 months [ Time Frame: baseline, 3 months, and 6 months ]
    An 8-item psychometrically validated self-report questionnaire on a 10- point Likert Scale (1= Not confident at all; 10 = Totally confident) that measures diabetes self efficacy. Diabetes self-efficacy is a critical pathway to improved self-management and refers to an individual's confidence in their ability to perform health behaviors that influences the behaviors in which they actually engage. DSES will be administered at 3 times point: baseline, 3 months and 6 months.

  2. Change in Mindfulness Attention and Awareness Scale (MAAS)at 3 months and 6 months [ Time Frame: baseline, 3 months, and 6 months ]
    A 15-item psychometrically validated questionnaire on a 6-point Likert scale (1=Almost Always and 6= Never) Higher scores reflect high states of Mindfulness. 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. MAAS will be administered at 3 times point: baseline, 3 months and 6 months

  3. Change in Hemoglobin A1c at 3 months and 6 months [ Time Frame: baseline, 3 months, and 6 months ]
    A test that measures the level of hemoglobin A1c in the blood as a means of determining the average blood sugar concentrations for the preceding two to three months. All tests will be performed at VAPHS according to national Glyco-hemoglobin Standardization Program approved methods. Hba1c will be measured at 3 times point: baseline, 3 months and 6 months


Other Outcome Measures:
  1. Change in 6-item PROMIS short form v1.0 Pain Interference 6 b at 3 months and 6 months [ Time Frame: baseline, 3 months , 6 months ]
    A psychometrically validated 6-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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Monica M. DiNardo, PhD ARNP CDE VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02928952    
Other Study ID Numbers: NRI 15-150
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are currently no plans to share Individual Participant Data (IPD).

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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
Keywords provided by VA Office of Research and Development:
Mindfulness
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases