Clinical trial NCT02407132: Family Model of Diabetes Self-Management Education in the Marshallese Community
Official title: Family Model of Diabetes Self-Management Education in the Marshallese Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-04-02
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: Background and Rationale

The Marshallese population suffers from a significant and disproportionate burden of type 2 diabetes. The rate of type 2 diabetes among the Marshallese is one of the highest of any population group in the world-at least 400% higher than the general US population.1-7 Our systematic review of local, national, and international data found estimates of diabetes in the Marshallese (populations living both in the US and Marshall Islands) ranging from 30% to 50% compared to 8.3% for the US population and 4% worldwide.4-7 Causes for this disparity have not been completely unraveled and are partially embedded in the history of the Marshall Islands. Between 1946 and 1958, the US military tested nuclear weapons on several of the Marshall Islands. People who inhabited the bombed islands and atolls were relocated, but Marshallese living on nearby atolls that were not evacuated experienced nuclear fallout during and after nuclear tests. Because of the nuclear testing, the Atomic Energy Commission lists the Marshall Islands as one of the most contaminated places in the world, and several studies demonstrate ongoing health effects from the nuclear testing.8 The nuclear contamination resulted in significant and long-term changes in diet and lifestyle of the Marshallese.9-12 These changes in diet and lifestyle have contributed to an increased rate of type 2 diabetes.2-5,16-19 The Compact of Free Association between the Republic of the Marshall Islands (RMI) and the US, signed in 1986, permits the US to conduct military activities in the Marshall Islands and also allows Marshallese individuals to come to the US without a visa. The Marshallese population living in the US tripled between 2000 and 2010, with Arkansas having the largest population of Marshallese living outside of the RMI.

Diabetes self-management education (DSME) is an evidence-based model that has been shown to improve glycemic control, reduce diabetic complications, and reduce the cost of managing diabetes. Standard implementation approaches of DSME have not been effective in Marshallese populations, indicating that a unique approach tailored to this population is needed.2-3 Because of the disproportionate burden of diabetes and related complications experienced by this high-risk population, a novel adaptation of the evidence-based DSME model and subsequent testing in a community-based setting are needed.

Using a Community Based Participatory Research (CBPR) approach, we have conducted four focus groups and individual interviews with the Marshallese community to better understand how to best address the well-established need for diabetes education. Through interviews and focus groups, Marshallese participants pointed out that the delivery method and the concept of self-management as an individual experience are problematic components. DSME was designed with a very Western societal approach, which is highly individualistic. The Marshallese have a highly collectivist culture and the idea of -self‖ management is counter to their cultural values. As stakeholders described, -we eat together from one pot. For one person to refuse the food from that one pot is not just inconvenient, it is shameful. It shames the person and the person's family. It is not an acceptable option. We will not do it. The interviewees stated that any changes must be a family change. Incorporating collectivist and family concepts into the delivery mechanism is imperative. Through the interviews and focus groups, the Marshallese community suggested that DSME be implemented within a family model with a family group receiving DSME so that the entire family can benefit and the patient can be supported in their effort to make lifestyle changes. Because \~30-50% of the Marshallese community have type 2 diabetes, this approach could be even more beneficial.

Hypothesis and/or Specific Aims or Objectives

We hypothesize that a culturally adapted DSME implemented in a family model will result in better diabetes management outcomes compared with standard DSME for the Marshallese.

In the family delivery model, a participant is encouraged to invite his/her family members to the diabetes educational sessions. As outlined by stakeholders, the model has several potential benefits. First, patients are empowered to invite the people they define as family and as appropriate for taking part in the sessions with them. Second, the education will engage the patient-defined support unit. Third, given the high-rate of diabetes within the community, it is highly probable that others within the group will have Type 2 diabetes or pre-diabetes and may benefit from the intervention as well.

Our aim is to test an Adapted DSME using a mixed-methods approach. Marshallese participants with type 2 diabetes will be recruited. Those who are assigned to the family model will be asked to invite one to ten adult members of their families to participate in the DSME. Given that \~30-50% of adults in the Marshallese community have type 2 diabetes, and the Marshallese typically have large families, recruitment for this nontraditional model is plausible. Furthermore, the method was designed from input from our CBPR partnership with the Marshallese.

This research is highly translational. It will help bridge the gap between knowledge of an effective DSME intervention and actual implementation of the intervention among a Pacific Islander population with especially high rates of type 2 diabetes and significant health disparities.

Eligibility 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

Primary outcomes:
measure: Glycemic Control, Measured by Change in Adjusted Mean HbA1c (%) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
timeFrame: Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention
Secondary outcomes:
measure: Change in Mean BMI From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention
timeFrame: Baseline, Immediate post-intervention; 6 months post-intervention; 12 months post-intervention
measure: Change in Mean Total Cholesterol (mg/dL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
timeFrame: Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention
measure: Change in Mean High-density Lipoproteins (HDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention.
timeFrame: Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention
measure: Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Check Blood Glucose Daily
timeFrame: Baseline, 12 months post-intervention
measure: 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
timeFrame: Baseline, 12 months post-intervention
measure: 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
timeFrame: Baseline, 12 Months Post-Intervention
measure: Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Eye Exam in Past 12 Months
timeFrame: Baseline, 12 Months Post-Intervention
measure: Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Maintain a Normal Weight
timeFrame: Baseline, 12 Months Post-Intervention
measure: Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Engage in Recommended Level of Physical Activity
timeFrame: Baseline, 12 Months Post-Intervention
measure: Change in Mean Fasting Glucose From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention
timeFrame: Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention
measure: Change in Mean Low-density Lipoproteins (LDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention
timeFrame: Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention
measure: Change in Mean Triglycerides From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 12 Months Post-intervention
timeFrame: Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: University of Arkansas for Medical Sciences Northwest
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Peter O Kohler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.