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

NCT02407132 | Completed Results

• 1 other identifier: 203482
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (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.

  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.

  Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention

Secondary Outcomes (12)

• Change in Mean BMI From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention

  Baseline, Immediate post-intervention; 6 months post-intervention; 12 months post-intervention

• Change in Mean Total Cholesterol (mg/dL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.

  Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention

• Change in Mean High-density Lipoproteins (HDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.

  Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention

• Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Check Blood Glucose Daily

  Baseline, 12 months post-intervention

• 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

  Baseline, 12 months post-intervention

Study Arms (2)

Standard DSME

ACTIVE COMPARATOR

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

Adapted DSME

EXPERIMENTAL

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

Interventions

Adapted DSME BEHAVIORAL

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

Adapted DSME

Standard DSME BEHAVIORAL

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.

Standard DSME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Younger than 18

Sponsors & Collaborators

• University of Arkansas: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences Northwest

Fayetteville, Arkansas, 72703, United States

Location

Related Publications (3)

• Felix HC, Narcisse MR, Long CR, McElfish PA. Effects of a family diabetes self-management education intervention on the patients' supporters. Fam Syst Health. 2020 Jun;38(2):121-129. doi: 10.1037/fsh0000470. Epub 2020 Apr 13.

  PMID: 32281816 DERIVED

• McElfish PA, Purvis RS, Scott AJ, Haggard-Duff LK, Riklon S, Long CR. "The results are encouragements to make positive changes to be healthier:" qualitative evaluation of Marshallese participants' perceptions when receiving study results in a randomized control trial. Contemp Clin Trials Commun. 2020 Feb 19;17:100543. doi: 10.1016/j.conctc.2020.100543. eCollection 2020 Mar.

  PMID: 32140610 DERIVED

• McElfish PA, Long CR, Kohler PO, Yeary KHK, Bursac Z, Narcisse MR, Felix HC, Rowland B, Hudson JS, Goulden PA. Comparative Effectiveness and Maintenance of Diabetes Self-Management Education Interventions for Marshallese Patients With Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2019 May;42(5):849-858. doi: 10.2337/dc18-1985. Epub 2019 Mar 12.

  PMID: 30862659 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

We were unable to collect valid measures for fasting glucose, low-density lipoproteins (LDL), and triglycerides, as participants reported they had not adhered to instructions to fast before data collection events.

Results Point of Contact

• Title: Dr. Pearl McElfish
• Organization: University of Arkansas for Medical Sciences

pamcelfish@uams.edu

479-713-8680

Study Officials

• Peter O Kohler, M.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 2, 2015
• Study Start: June 1, 2015
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: June 20, 2019
• Results First Posted: June 20, 2019

Record last verified: 2019-03

Locations

US (1)