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Family Model of Diabetes Self-Management Education in the Marshallese Community

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ClinicalTrials.gov Identifier: NCT02407132
Recruitment Status : Completed
First Posted : April 2, 2015
Results First Posted : June 20, 2019
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
The investigators will conduct a comparative effectiveness evaluation using a randomized control trial design of a culturally adapted family model of Diabetes Self-Management Education (Adapted DSME) compared with Standard DSME within the Marshallese population. The family model will cover the same concepts as the standard format. However, the family model will incorporate culturally-adapted education and recommendations aimed at engaging family members in the management of the primary participant's diabetes, and family members will be invited to fully participate in the study. By contrast, the standard model provides diabetes self- management education to the diabetic participant only, and the participant's family members do not participate in the classes or any other part of the study. Biometric and survey data will be collected pre-intervention, post-intervention, 6 months post-intervention, and 12 months post-intervention. A qualitative debriefing session will be held for each family between the final DSME session and the 6 month post-intervention to obtain qualitative data regarding the participant's perceptions of the intervention and implementation process.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Adapted DSME Behavioral: Standard DSME Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Family Model of Diabetes Self-Management Education in the Marshallese Community
Study Start Date : June 2015
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Arm Intervention/treatment
Active Comparator: Standard DSME
Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
Behavioral: Standard DSME
Active Comparator: Standard DSME Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.

Experimental: Adapted DSME
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
Behavioral: Adapted DSME
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.




Primary Outcome Measures :
  1. Glycemic Control, Measured by Change in Adjusted Mean HbA1c (%) 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, 12 months post-intervention ]
    A Siemens analyzer (point of care) was utilized to calculate HbA1c levels for each participant. The primary outcome measure was change in adjusted mean HbA1c (%) from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants. The mean HbA1c values presented here have been adjusted, whereas the mean HbA1c values presented in the Baseline Data section are unadjusted.


Secondary Outcome Measures :
  1. Change in Mean BMI 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; 12 months post-intervention ]
    Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb (0.2 kg) using a calibrated digital scale. Height (without shoes) was measured to the nearest 0.5 cm using a stadiometer. Weight and height were used to compute a continuous measure of BMI (kg/m²).

  2. Change in Mean Total Cholesterol (mg/dL) 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, 12 months post-intervention ]
    Through finger prick blood collection, point of care tests were used to test fasting lipids using a commercial lipid panel kit and Cholestech LDX analyzer. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants.

  3. Change in Mean High-density Lipoproteins (HDL) 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, 12 months post-intervention ]
    A commercial lipid panel kit and Cholestech LDX analyzer were used to assess HDL levels. The outcome measure was change in mean HDL from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention. Analyses were adjusted for baseline sex, age, education, marital status, employment status, use of diabetes medication, and households containing multiple participants.

  4. Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Check Blood Glucose Daily [ Time Frame: Baseline, 12 months post-intervention ]
    This measure assesses whether or not each participant reported checking her/his blood glucose at least daily at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)

  5. Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Seen Doctor or Other Health Professional in Past 12 Months for Diabetes [ Time Frame: Baseline, 12 months post-intervention ]
    This measure assesses whether or not each participant reported seeing a doctor, nurse, or other health professional for her/his diabetes within the past 12 months at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)

  6. Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Foot Exam by Doctor or Other Health Professional in Past 12 Months [ Time Frame: Baseline, 12 Months Post-Intervention ]
    This measure assesses whether or not each participant reported having a health professional check her/his feet for any sores or irritations in the past 12 months at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)

  7. Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Eye Exam in Past 12 Months [ Time Frame: Baseline, 12 Months Post-Intervention ]
    This measure assesses whether or not each participant reported having an eye exam in which the pupils were dilated in the past 12 months at baseline and 12 months post-intervention. This measure of participant-reported current level of diabetes self-care was assessed through an item from the Behavioral Risk Factor Surveillance System (BRFSS) Diabetes Module. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)

  8. Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Maintain a Normal Weight [ Time Frame: Baseline, 12 Months Post-Intervention ]
    This measure assesses whether or not each participant had a normal weight at baseline and 12 months post-intervention as indicated by body mass index (i.e., body mass index between 18.5 to 24.9). Participant weight (without shoes) was measured in light clothing to the nearest 0.5 lb (0.2 kg) using a calibrated digital scale. Height (without shoes) was measured to the nearest 0.5 cm using a stadiometer. Weight and height were used to compute a continuous measure of BMI (kg/m²). (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)

  9. Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Engage in Recommended Level of Physical Activity [ Time Frame: Baseline, 12 Months Post-Intervention ]
    This measure assesses whether or not each participant reported engaging in 60 minutes or more of vigorous activity per week or 150 minutes or more of moderate activity per week at baseline and 12 months post-intervention. This measure was lightly adapted from the measure of physical activity used here: L. Jiang, S. Chen, B. Zhang, J. Beals, C.M. Mitchell, S.M. Manson, et al. Longitudinal patterns of stages of change for exercise and lifestyle intervention outcomes: an application of latent class analysis with distal outcomes. Prev. Sci., 17 (2016), pp. 398-409. (Because three of the diabetes self-care behaviors we assessed are expected to occur annually (e.g., annual doctor visit), analyses of self-care behaviors focus on change from baseline to 12 months post-intervention to allow for a year to elapse between time points.)

  10. Change in Mean Fasting Glucose 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, 12 Months Post-Intervention ]
    Informally and in response to a survey item, many participants reported that they had not adhered to instructions to fast before data collection. For this reason, we were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides.

  11. Change in Mean Low-density Lipoproteins (LDL) 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, 12 Months Post-Intervention ]
    Informally and in response to a survey item, many participants reported that they had not adhered to instructions to fast before data collection. For this reason, we were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides.

  12. Change in Mean Triglycerides 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, 12 Months Post-Intervention ]
    Informally and in response to a survey item, many participants reported that they had not adhered to instructions to fast before data collection. For this reason, we were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides.



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:

Primary Participant:

  • Must be 18 years or older
  • Self-reported Diabetes Mellitus Type 2 diagnosis by a health care provider
  • Self-reported Marshallese ethnicity or descent

Secondary (Family) Participant:

  • Must be 18 years or older

Exclusion Criteria:

  • Younger than 18

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): NCT02407132


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Northwest
Fayetteville, Arkansas, United States, 72703
Sponsors and Collaborators
University of Arkansas
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Peter O Kohler, M.D. University of Arkansas
  Study Documents (Full-Text)

Documents provided by University of Arkansas:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02407132    
Other Study ID Numbers: 203482
First Posted: April 2, 2015    Key Record Dates
Results First Posted: June 20, 2019
Last Update Posted: June 20, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases