Self-Management and Glycemic Targets in Adult Haitian Immigrants With Type 2 Diabetes

Research Protocol

Abstract

Background 

Type 2 diabetes (T2D) is a chronic condition affecting more than 34.2 million U.S. adults, and people of African descent have a disproportionate burden. Haitian immigrants’ unique cultural and biological factors put them at elevated risk for T2D-related complications. Despite prior research highlighting the success of multimethod approaches to T2D self-management behaviors on glycemic targets, a dearth of studies have used these methods to improve diabetes self-management in this marginalized population.

Objectives 

This article describes a repeated-measures design protocol of a going study about self-management behaviors among adult Haitian immigrants with T2D and characterizing their barriers to T2D self-management.

Methods 

We will enroll 100 Haitian immigrants aged 18–64 years who have lived with T2D for at least 1 year. Using multiple recruitment methods and Research Electronic Data Capture, subjective and objective data on T2D self-management practices, glucose variability via continuous glucose monitor, and a comprehensive view of physical activity via actigraphy are collected.

Results 

Data analysis will follow a two-part approach mirroring the two primary study objectives.

Discussion 

Findings from the study will guide the development and testing of a culturally tailored diabetes self-management education program that will contribute essential information about best practices for this population and break barriers that may impede research on unique individuals and subsequent effective self-management.

Type 2 diabetes (T2D) is a chronic condition affecting more than 34.2 million U.S. adults (^{Centers for Disease Control and Prevention [CDC], 2022}). The prevalence of T2D has increased over time, which has been attributed to widespread obesity, unhealthy diets, and physical inactivity (^{CDC, 2022}; ^{International Diabetes Federation, 2021}). There is a significant variation in T2D prevalence among ethnicities. Although 16.4% of non-Hispanic Blacks have T2D, non-Hispanic Whites have a T2D prevalence of 11.9% (^{CDC, 2022}). Haitian immigrants residing in the United States are often grouped with other non-Hispanic Blacks; however, they experience higher rates of diabetes-related complications and death than other ethnic populations (^{Huffman et al., 2011}; ^{Magny-Normilus & Whittemore, 2020}). This has been attributed to the specific T2D risk factors associated with a unique cultural background and likely a genetic predisposition that differs from other Black subgroups (^{Cheema et al., 2015}; ^{Exebio et al., 2012}; ^{Huffman et al., 2011}; ^{Magny-Normilus et al., 2020}; ^{Magny-Normilus & Whittemore, 2020}). Health beliefs, immigration, acculturation, cultural traditions, and biological factors unique to Haitian immigrants influence diabetes self-management and therefore deserve careful study. Diabetes self-management is essential to meeting glycemic targets and preventing T2D-related health complications (^{Grady & Gough, 2014}; ^{Grey et al., 2015}). Recognized diabetes self-management behaviors are healthy eating, being active, blood glucose monitoring, taking medication, problem-solving, healthy coping, and risk reduction (^{Association of Diabetes Care and Education Specialists & Kolb, 2021}). In studying T2D self-management, it is vital to account for both cultural and biological influences.

This article outlines a methodology developed to assess and account for the unique factors affecting the Haitian immigrant population. ^{Grey et al.’s (2015)} Revised Self- and Family Management Framework guided this methodology’s conceptual framework (Figure 1). The adaption considers conceptual and empirical literature specific to adult Haitian immigrants with T2D (^{Magny-Normilus et al., 2020}; ^{Magny-Normilus & Whittemore, 2020}). The framework provides this methodology with a structure to (a) examine potential barriers to self-management behaviors (proximal outcomes) such as sociodemographic factors, health status, psychosocial factors, and the environment and (b) describe the correlations between potential barriers of T2D self-management behaviors to clinical outcomes (distal outcomes), which are defined as hemoglobin A1c (HbA1c) and glucose variability in adult Haitian immigrants with T2D. This article aims to describe a methodology specific to summarizing self-management behaviors among adult Haitian immigrants with T2D and characterize barriers to self-management using multimethod.

FIGURE 1: Proposed conceptual framework of Type 2 diabetes self-management and glycemic targets in Haitian immigrants with Type 2 diabetes.

METHODS

Study Design, Sample, and Setting

Recruitment inclusion criteria for these descriptive repeated-measures design study will be as follows:

1. Haitian immigrants aged 18–64 years,
2. diagnosis of T2D for at least 1 year,
3. U.S. resident for at least 1 year,
4. willing and able to participate and wear a physical activity and continuous glucose monitoring (CGM) devices,
5. English speaking,
6. not participating in any competing studies of T2D currently, and
7. receiving health services from a participating clinic at time of data collection.

With institutional review board approval, recruiting is conducted from two urban outpatient clinics in the northeast U.S. region that have served the Haitian immigrant community for over 20 years and provided care to ≥400 Haitian immigrant patients. The clinics are federally qualified health centers, and the research team has no direct involvement with delivering care to prospective study participants.

Sample Size Justification

G*Power 3.1.9.2 program calculated a sample size of 74, using the following parameters: alpha (.05), power (.9), and effect size (0.3) for multiple regression (^{Erdfelder et al., 1996}; ^{Kadam & Bhalerao, 2010}). Without adequate data to estimate possible dropout rates for Haitian immigrants with T2D, other immigrant population attrition rates of 20%–30% were used; therefore, 26 participants were added for 100 projected participants (^{Cheema et al., 2015}; ^{Fang et al., 2015}; ^{Lowe et al., 2009}; ^{Peña-Purcell et al., 2011}).

Procedures

The recruitment approaches are as follows:

1. flyers in English and Haitian Creole describing the study posted on clinical site bulletin boards;
2. lists of potential participants and their primary healthcare providers; and
3. given the ongoing pandemic, e-mail prospective participant providers and potential participants with an opt-out approach using a healthcare provider letter to contact their patients who meet study inclusion, followed by a subject recruitment letter via mail.

If a recruit is eligible, interested, and verbally agrees to participate, their first encounter will be scheduled. Participants will be asked to complete three data collection sessions for up to 14 days, with data collected via several measurement tools (Figure 2). Variables and measures to be collected during the study include demographic, cultural, and biophysical characteristics of participants associated with T2D and self-management (Table 1).

FIGURE 2: Encounter timeline, process, and data collected.

TABLE 1 - Summary of Measures

Measure	Variables	Methods of collection
Demographic and clinical characteristics	Age, gender, marital status, income, duration of time in the United States, level of education, language spoken at home, confirmation and duration of Type 2 diabetes, insurance, medication/pharmacy data (type, number, and prescription/refill requests), comorbidities (hypertension, hyperlipidemia), and most recent HbA1c.	EMR and self-report
Self-reported diabetes self-management	Included in questionnaire: general diet, specific diet, blood glucose monitoring, foot care, smoking. Reliability and validity have been established in adults of diverse race/ethnicity.	Questionnaire: Summary of Diabetes Self-Care Activities Scale
Food security	Included in questionnaire: 16 items that assess financially based food insecurity in households: includes items related to the frequency at which a household has not been able to access enough food in the last 3 months (Cronbach’s alpha = .92; strong Criterion validity). Previous studies have shown the ELCSA to have high internal consistency (Cronbach’s alpha = .92) and strong criterion validity.	Questionnaire: Latin American and Caribbean Household Food Security Scale (ELCSA)
Self-reported medication adherence	Included in questionnaire: 10 items to assess overall thoughts and reasons for medications. The MARS has demonstrated acceptable internal consistency with a Cronbach’s alpha of .77. The MARS has been used in ethnic groups and is known for its ease of application.	Questionnaire: Medication Adherence Report Scale (MARS)
Self-reported physical activity	Included in questionnaire: Frequency of sustained moderate to physical activity, time in sedentary, light, moderate, and vigorous activity. The tool has been validated with correlation coefficients ranging from r = .13–.69 and demonstrated adequate test–retest reliability (ICC = .49–.68).	Questionnaire: Paffenbarger Physical Activity Questionnaire
Self-reported acculturative stress	Included in questionnaire: Acculturative stress, perceived discrimination toward immigrant populations. Excellent reliability for the total scale has been shown in a variety of populations (alpha = .87–.89) and for use with various immigrant groups, including Haitian.	Questionnaire: Societal Attitudinal, Familial, and Environmental Acculturative Stress Scale
Self-reported discriminative stress	Included in questionnaire: Experiences of specific racist events and degree of the stressfulness of incidences on a cultural, institutional, individual, and global scale. Reliability and validity have been established with Cronbach’s alphas of .69–.78 and .79–.81.	Questionnaire: Index of Race-Related Stress–Brief Version
Dietary intake	Included in questionnaire: specific frequency of type of food intake and preparation. Calories, % fat intake, and fruit and vegetable intake will be calculated.	Recall
Objective physical activity	Frequency, duration, and intensity of physical activity. Three axial accelerometers demonstrate excellent reliability with no evidence to suggest differences in brand or type of sensor.	Actigraphy: hip accelerometer
Glucose control	HbA1c	Self-report and EMR
Glucose variability	Included in CGM: standard deviation, coefficient of variation, J-index, glycemic variability percentage, area under the curve of hyperglycemic, hypoglycemia.	CGM
Qualitative	Acceptability of device wearing, study protocol, and barriers to self-management.	Interviews

Note. HbA1c = hemoglobin A1c; EMR = electronic medical record; CGM = continuous glucose monitor.

Encounter 1: Consent, Survey Completion, and Instruction in Using Devices

The research staff will review the study requirements, obtain written informed consent, and begin data collection. Study requirements will be reinforced to ensure the participant understands the burden before deciding to participate. Self-report demographic information will be collected, and participants will receive instructions on how to use the two devices. In addition, participant medical records will be used to complement and confirm self-report data and collect clinical characteristics (comorbidities, recent HbA1c, and T2D medication). If no data on the HbA1c level are available within 3 months from the visit, participants and providers will be alerted.

During the initial encounter, we will use the following: (a) the Summary of Diabetes Self-Care Activities Scale (SDSCA; alpha = .85 and .94; ^{Toobert et al., 2000}), (b) the Dietary Diary 3-day data, (c) the adapted version of the Latin American and Caribbean Household Food Security Scale to assess food security (Cronbach’s alpha = .92; ^{Pérez-Escamilla et al., 2008}), (d) the Medication Adherence Report Scale (MARS; Cronbach’s alpha = .77; ^{Tommelein et al., 2014}), (e) the Paffenbarger Physical Activity Questionnaire (PPAQ) in conjunction with Actigraphy (ICC = .49–.68; ^{Paffenbarger et al., 1993}), (f) the 24-item version of the Societal, Attitudinal, Familial, and Environmental Acculturative Stress Scale (alpha = .87–.92; ^{Fuertes & Westbrook, 1996}; ^{Hovey & King, 1996}), and (g) the Index of Race-Related Stress–Brief Version (Cronbach’s alpha = .69–.78 and .79–.81; ^{Chapman-Hilliard et al., 2020}). These measurements will provide subjective information on diabetes self-management behaviors such as diet, physical activity, blood glucose monitoring, taking medication, levels of food insecurity, medication adherence, and racial discriminatory stress (Table 1).

The objective–clinical measurements will collect data on physical activity (ActiGraph GT9X) and glucose variability (Freestyle Libre Pro CGM). These objective measurements will provide real-time frequency, duration, and intensity of physical activity, as well as nonwear periods and reasoning (^{Strath et al., 2005}), and glycemia data, such as J-index, glycemic variability percentage, and area under the curve of hyperglycemia and hypoglycemia with real-time glycemic data continuously for up to 14 days (^{Rodbard, 2016}; ^{Suh & Kim, 2015}). In conjunction with the subjective data, these measurements will provide a comprehensive view of physical activity and real-time glycemic data continuously for up to 14 days.

Participants with prior CGMs will continue to use their personal devices. Each participant will be given instructions, and the contact information of the study’s staff should questions or the need for assistance arises. Participants will be given a $20 gift card after the initial encounter.

Encounter 2: Data Collection

Accelerometer and CGM data collection continues for up to 14 consecutive days. For the first 3 days of wearing the devices, a research staff member will call the study participant daily to answer questions, determine protocol adherence with diet recall, and remind participants to charge the physical activity device. Participants will return the CGM and accelerometer devices using a prepaid self-addressed mailer. Participants will be given $35 after the equipment is successfully returned.

Encounter 3: Interviews

Interviews will be conducted on a subsample of approximately 30 participants after the completion of Encounter 2 eliciting acceptability of wearing the devices, the study protocol, and barriers to self-management. The principal investigator will conduct audio-recorded individual interviews over the phone using a semistructured interview guide. The interviews will last approximately 30 minutes, and field notes will be written prior to and after each interview.

During the first visit, participants will be asked about their interest in participating in the qualitative portion of the study. Interviews will continue to be conducted until data saturation is achieved per standard practice in qualitative research (^{Creswell, 2013}; ^{Sandelowski, 2010}). After the qualitative interview, a $20 gift card will be given to participants to show appreciation for their participation. This gift card would bring total compensation to $75 per participant.

Data Analysis

Statistical analysis will be used to evaluate the relationships between demographic, psychosocial environmental factors, and diabetes self-management behaviors between subjective and objective measures of self-management and between each facet of self-management and each measure of glycemic targets. By combining objective and self-reported physical activity and glycemic target quantitative data, unique factors about this population may be more easily discovered.

Descriptive statistics will be used to evaluate sample characteristics. As appropriate, continuous variables will be reported as means and standard deviations or medians and interquartile ranges. Categorical variables will be reported as counts and proportions of each response.

The data analysis follows a two-part approach, mirroring the two primary objectives of the study. Regarding the description of the self-management behaviors, information from the diet recall, physical activity recall, total activity counts per day, percentage of moderate and vigorous physical activity, and measures of medication adherence will outline the lifestyle habits in the Haitian immigrant population. Multiple linear regression will determine the factors associated with these self-management behaviors, including demographic and clinical characteristics, food insecurity, acculturative stress, and discrimination stress. Using these behaviors as predictors, glycemic target outcomes will be analyzed for their effect. Multivariate regression techniques using generalized linear mixed models with random effects by the clinic with demographic characteristics and diabetes duration adjustments will be used to compare the relative importance of each given behavior on outcomes. In secondary analyses, correlations will be evaluated between self-reported and objective measures of self-management, including physical activity (PPAQ vs. Actigraphy), medication adherence (MARS vs. SDSCA), and diet (SDSCA vs. daily diary), using Pearson and Spearman rank-order correlation methods.

Interview data collected will be analyzed using the constant comparison method—supported by Qualitative Solutions and Research’s NVivo 12 software—to elucidate perspectives about self-management. This method will capture repeated themes from qualitative data to uncover experiential knowledge to inform clinical understanding of a phenomenon, in this case, T2D self-management of Haitian immigrants (^{Creswell, 2013}; ^{Sandelowski, 2010}; ^{Whittemore et al., 2001}). An experienced transcriptionist will transcribe the interviews verbatim, and transcripts will be compared to tapes for accuracy. The primary coder will develop coding categories and upload transcribed data into NVivo to assign codes of text. Coded data will then be reviewed to identify themes across participants by the coder. The coder will read the data multiple times, and segmented texts (nodes) will be assigned codes; these nodes will organize the data into preliminary themes. A priori will be identified before a second coder will review and verify the analysis. Discrepancies will be resolved through discussion of interpretations and comparisons to achieve interrater reliability using Cohen’s kappa. Analysis will begin during data collection and transcripts generation to identify and use emerging themes to inform future interviews and progress toward thematic saturation (^{Creswell, 2013}; ^{Sandelowski, 2010}).

Data will be triangulated to elucidate the barriers to self-management identified qualitatively with concepts measured quantitatively, to help better understand possible discrepancies between subjectively and objectively measured aspects of self-management and further explore the mechanisms underlying the relationships between environmental context and barriers to self-management.

DISCUSSION

This article outlines a proposed multifaceted methodology to assess self-management of T2D that is sensitive to the unique shared cultural background and biological factors of Haitian immigrants. Multiple quantitative data sources—along with qualitative strategy—will provide a holistic perspective on individual self-management and its effect on the ability of the individual to hit glycemic targets. Highly detailed, high-frequency measurement of activity and glucose levels complements the self-reported instruments by providing an objective benchmark measurable under the context of a participant’s subjective responses to the qualitative instruments. Discriminative and acculturative stress will be measured to provide understanding the influence of discrimination and acculturation on Haitian immigrants and their association with T2D.

Strengths and Limitations

The cross-sectional nature of the supported study described above will limit inference. Participants’ burden and the proposed recruitment are from one geographic area, which could affect study completion and the generalizability of the study findings. Despite these limitations, the repeated-measures design is a major strength. The study design allows self-report and objective data collection and helps control social desirability biases. This is important as the study findings intend to guide the development and testing of a culturally tailored diabetes self-management education program that provides critical information and best practices for this population.

Conclusion

This is currently an active study with 81 participants enrolled. The study’s findings will help develop a T2D self-management program that is culturally tailored to Haitian adults’ personal beliefs and cultural health practices. The intervention will be designed to acknowledge and overcome identified barriers to effective T2D self-management.