Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations

Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations
  • Change in mean BMI from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention [ Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]

    BMI will be collected by measuring participant height (without shoes) using a stadiometer, and measuring participant weight (without shoes) using a calibrated digital scale. Weight and height will be used to compute a continuous measure of BMI. BMI at 18 months post-intervention will be abstracted from participant medical records. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.

  • Change in mean waist circumference from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention medical record abstraction [ Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]

    Waist circumference will be collected by measuring participant’s waist using a flexible tape measure. Waist circumference at 18 months post-intervention will be abstracted from participant medical records.The analytic approach for secondary outcomes will be similar to those used for the primary outcome.

  • Change in mean blood pressure (systolic & diastolic, mmHg) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention [ Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]

    Blood pressure will be measured with a sphygmomanometer and stethoscope or digital blood pressure device with the participant seated and arm elevated. Blood pressure at 18 months post-intervention will be abstracted from participant medical records.The analytic approach for secondary outcomes will be similar to those used for the primary outcome.

  • Change in mean total cholesterol (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention [ Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention medical records abstraction ]

    Through finger prick blood collection, point of care tests will be used used to test lipids using a commercial lipid panel kit and Cholestech LDX analyzer. Total cholesterol at 18 months post-intervention will be abstracted from participant medical records. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.

  • Change in mean high-density lipoproteins (HDL) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention [ Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months 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. HDL at 18 months post-intervention will be abstracted from participant medical records. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.

  • Change in mean low-density lipoproteins (LDL) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention [ Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months 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. LDL Blood pressure at 18 months post-intervention will be abstracted from participant medical records. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.

  • Change in mean triglycerides from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention [ Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months 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. Triglycerides at 18 months post-intervention will be abstracted from participant medical records. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.

  • Change in mean blood glucose from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention [ Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention ]

    Through finger prick blood collection, point of care tests will be used used to test random blood glucose (not fasting). Blood glucose at 18 months post-intervention will be abstracted from participant medical records. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.

  • Change in diabetes self-management behaviors from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention [ Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months 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. The SDSCA will be administered to participants at baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.

  • Change in diabetes self-efficacy from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention [ Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months 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 20 items to assess self-reported confidence in managing aspects of their diabetes. The DMSES will be administered to participants at baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.

  • Change in medication adherence from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention [ Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention ]

    The Adherence to Refills and Medications Scale for Diabetes Medicines (ARMS-D) will be used to measure patient’s adherence to their medications (if prescribed). The ARMS-D consists of 11 items to assess self-reported adherence to diabetes medications. The ARMS-D will be administered to participants at baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.

  • Change in diabetes-related distress from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention [ Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months 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. The PAID-5 will be administered to participants at baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.

  • Change in diabetes-related quality of life from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention [ Time Frame: Baseline, immediate post-intervention, 6 months post-intervention, and 12 months 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. The DIDP will be administered to participants at baseline, immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. The analytic approach for secondary outcomes will be similar to those used for the primary outcome.

  • Source: View full study details on ClinicalTrials.gov

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    October 22, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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