DiabetesNCT02407132
Family Model of Diabetes Self-Management Education in the Marshallese Community
A study testing Adapted DSME and Standard DSME in people with Diabetes, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Adapted DSME and Standard DSME
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Younger than 18
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences Northwest
Fayetteville, Arkansas, 72703
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Adapted DSME, Standard DSME
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted DSMEBehavioural
Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
Standard DSMEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Adapted DSME |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: 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.
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.
Measured: 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.
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.
Measured: 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
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.)
Measured: 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
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.)
Measured: Baseline, 12 months post-intervention
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
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.)
Measured: Baseline, 12 Months Post-Intervention
Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Eye Exam in Past 12 Months
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.)
Measured: Baseline, 12 Months Post-Intervention
Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Maintain a Normal Weight
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.)
Measured: Baseline, 12 Months Post-Intervention
Change in Probability of Performing Diabetes Self-care Behaviors From Baseline to 12 Months Post-intervention: Engage in Recommended Level of Physical Activity
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.)
Measured: Baseline, 12 Months Post-Intervention
Change in Mean Fasting Glucose From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 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.
Measured: Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention
Change in Mean Low-density Lipoproteins (LDL) From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 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.
Measured: Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention
Change in Mean Triglycerides From Baseline to Immediate Post-intervention, 6 Months Post-intervention, and 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.
Measured: Baseline, Immediate Post-Intervention, 6 Months Post-Intervention, 12 Months Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study startJun 2015
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Peter O Kohler, M.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407132
- Sponsor's protocol ID
- 203482
- Status last verified
- Mar 2019
- First submitted
- 30 Mar 2015
- Last updated
- 20 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 32281816McElfish 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.
PubMed 32140610McElfish 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.
PubMed 30862659
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Model of Diabetes Self-Management Education in the Marshallese Community
- ClinicalTrials.gov ID
- NCT02407132
- Acronym / sponsor ID
- 203482
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jun 2015
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Posted 20 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard DSME | Active comparator | Behavioral: Standard DSMEParticipants 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. |
| Adapted DSME | Experimental | Behavioral: Adapted DSMEParticipants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be 18 years or older
- Self-reported Diabetes Mellitus Type 2 diagnosis by a health care provider
- Self-reported Marshallese ethnicity or descent
- Must be 18 years or older
Key exclusion criteria (1 listed)
- Younger than 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted DSMEParticipants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting. | Behavioural | Adapted DSME |
| Standard DSMEActive 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. | Behavioural | Standard DSME |
Primary outcome
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.
12 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32281816Felix 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.
- Derived from this study: PubMed 32140610McElfish 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.
- Derived from this study: PubMed 30862659McElfish 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.
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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter O Kohler, M.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted DSME and Standard DSME in people with Diabetes, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Baseline, Immediate post-intervention, 6 months post-intervention, 12 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02407132, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.