Culturally tailored, peer-based sleep health education and social support to increase obstructive sleep apnea assessment and treatment adherence among a community sample of blacks: study protocol for a randomized controlled trial

Barbers, stylists, and leaders in faith-based communities are influential peers who are uniquely positioned to administer the proposed health education program [60, 61]. With adequate training and supervision, we expect that they will be able to utilize motivational enhancement techniques (the trans-theoretical change model) leading to the desired behavior, namely seeking OSA evaluation and adhering to treatment. These techniques have proven effective in a similar project that aimed to improve blood pressure control among blacks in community settings [62, 63]. As indicated in Fig. 4, the conceptual framework for training educators is modeled after Behavior Change Communication best practices and recommendations [64, 65]. Peer health educators are taught how to deliver tailored motivational sessions depending on where an individual is on the Stages of Change model (e.g., pre-contemplation, contemplation, preparation, action, maintenance, relapse prevention), which will be determined by baseline survey on Stages of Change [66]. For our current study, health educators will apply for the health educator job and will then be interviewed by the project manager and coordinator. To be considered for the peer health educator position, individuals have to meet the following qualifications: (1) previous experience working/volunteering with programs or organizations that tackle health or social issues in black communities; (2) knowledge of community resources and organizations in Brooklyn, Bronx, Queens, and/or Staten Island; (3) available to work evenings and weekends regularly; (4) ability to juggle priorities and manage time productively; (5) effective oral and written communication skills; (6) energetic open-minded people-person; (7) flexible, ability to change gears at a moment’s notice and ‘go with the flow’; (8) thrives in a fast-paced environment; (9) highly organized, pays attention to detail, and can follow strict protocols; (10) creative problem-solver; (11) comfortable using a computer (Word, Excel, Access, Outlook); and (12) a minimum of a high school education or GED. Peer health educators will not be required to have previous training or expertise in medicine or health training. Health educators will have a maximum case load of 3–4 participants at a given time and will provide support and counseling for each participant for 10 sessions.

A sleep health training manual was developed for health educators in the intervention arm. The manual delineates the mode of delivery, details on objectives for each encounter, and the ideal and minimally acceptable intervention ‘dose’. The peer health educator will utilize a graded dosage based on the participant’s educational and motivation levels to seek OSA evaluation. For example, a peer health educator will provide more introductory messages about what is OSA to someone who is in the pre-contemplative phase, while the information and support they provide a participant in the action phase will be qualitatively different as they may be more likely to agree to OSA evaluation compared to someone at the pre-contemplative or contemplative phases. Generally, in the first encounter, the peer health educator begins with rapport building, exchanging pleasantries, inquiring about the participant’s welfare, and then starting with a discussion of general problems while gradually introducing sleep health messages. The peer health educator will also discuss benefits of reducing OSA health risk behavior (e.g., smoking, drinking, sedentary lifestyle and poor diet). In the second encounter, the educator reinforces the importance of OSA evaluation and overcoming barriers and inquires if the participant has had a home visit. In the second encounter the peer health educator addresses decisional conflicts and encourages the participant to make an appointment for OSA evaluation. In subsequent encounters, the peer health educator inquiries about the general welfare and health status of the participant, reiterates health messages, and inquires whether the participant has had an OSA evaluation and/or has received treatment. The manual also enumerates strategies for overcoming challenges, specifies referral procedures, and describes strategies to check participants’ understanding of information and the mechanisms in place for monitoring fidelity.

Training to support and monitor fidelity to the intervention will be conducted in a standardized manner to (1) ensure that it is similar for all peer health educators and to ensure adherence to intervention protocol, (2) ensure educator’s skill acquisition using well-defined criteria (they will be certified before the intervention begins and periodically), (3) minimize drift in skills by providing booster sessions through both in vivo observations and review of behavioral checklists, and (4) accommodate differences in skill levels, experience, and professional background of educators.

Peer health educators will attend six training sessions on the basics of sleep science, motivational interviewing, ethics in research, and assessment and treatment of OSA. During these meetings, the importance of and rationale for the study as well as best practices of health education (such as providing accurate information about sleep and social support to participants) will be reinforced. In order to become an official peer health educator, individuals will have to successfully pass a scenario- and practice-based assessment. Peer health educators will be evaluated on the following competencies: (1) mastery of OSA and sleep health information, (2) Readiness to Change model, and (3) interpersonal skills (clear and effective communication, cultural sensitivity, ability to create positive and effective rapport) by a sleep health trainer and two sleep health specialists. Quarterly booster sessions will be held to reinforce treatment fidelity, address any project-related problems they may be encountering, and to foster self-confidence, self-efficacy, and enthusiasm for the study. Participants in the intervention arm will receive 10 counseling sessions from their matched health educator. Additional medical counseling may be provided to participants by the treating sleep physician or healthcare provider (who does not belong to the study) at the participants’ request.

Barbershops, salons, places of worship, and community-based organizations are ideal places to recruit hard-to-reach research participants such as racial/ethnic minorities. Evidence shows that a grassroots, community-centered approach using institutions that are well accepted, providing culturally and linguistically tailored health information, is the most effective way to reach racial/ethnic minorities in medically underserved areas [60, 67]. Barbershops, salons, and churches are ideal venues to communicate important health messages to blacks because of their established credibility as forums of in-depth discussions, information gathering, and sharing of personal experiences [60, 68, 69]. Thus, our intervention will use these establishments to meet the study’s aims. We will recruit from a wide network of barbershops, salons, places of worship, and community-based organizations.

We expect trained peer health educators will be influential in changing attitudes toward OSA evaluation because they have a high degree of homophily with their assigned participant [70, 71]. The theory of innovation suggests that interpersonal influence is the most effective way to change attitudes and share skills [71]. The ubiquity of racial/ethnic minority barbershops, beauty salons, places of worship, and community organizations across the United States [72] (credible institutions to communicate health messages to blacks), and the high degree of homophily (based on similarity in race, gender, beliefs, values, education, and social status) between peer educators and participants increases the likelihood of providing widespread OSA education across diverse groups.

Barbershops, salons, and churches will be selected based on established criteria, namely visibility, accessibility, cleanliness, safety, longevity, and cooperativeness [59]; preference will be accorded to those providing private meeting space for confidential interactions between educators and participants. Recruitment procedures will be discussed with site owners before scheduled visits. Respective owners will introduce the recruitment team, who will then approach potential participants (while waiting at the shop/salon or after church services) to describe the protocol. Participating recruitment sites are compensated US$ 250 annually. As in our previous study [73], staff will begin by exchanging pleasantries with potential participants followed by an introduction of study rationale. If interest is expressed, eligibility will be confirmed and consent obtained.

The sample will include blacks recruited from barbershops, salons, and faith-based organizations in New York City. We intend to screen approximately 1250 blacks and expect that approximately 398 will be enrolled in the study (Figs. 2 and 3). Research assistants will screen potential participants to determine eligibility on a wide range of exclusion and inclusion criteria at community-based settings such as faith-based organizations, barbershops, beauty salons, health fairs, and community-based organizations. If participants are eligible, research assistants will provide informed consent (Additional file 1). Participants will be re-consented if procedures of study significantly change.

Once baseline data is obtained, contact information of consenting participants will be provided to the data manager, who will maintain a registry of enrolled participants (control group and intervention group). This registry will be used to track them during the study period. Using computer generated schedules; the data manager will perform blind outcome ascertainment at 6 and at 12 months.

The data manager will perform interim analysis to ensure that selection and attrition biases do not occur if refusal occurs after recruitment or randomization. Selection bias might result from participant’s refusal to participate and attrition bias could result in an unbalanced design. Appropriate statistical techniques, such as Heckman 2-stage approach (Generalized Estimation Equations (GEE) Probit Model) [90] and Monte Carlo (EM algorithm) [91] analysis, will be used to address such biases or problems that might result from missing data. Adequate statistical corrections will be made in final statistical analyses to increase the generalizability of findings. Sociodemographic data obtained from those who did not participate will be used to determine whether individuals who did not participate are similar to those in the study (selection bias). Likewise, baseline characteristics of those who withdrew from the study will be contrasted with completers to determine whether any attrition bias may have occurred. Site-specific effects (shops vs. salons vs. faith-based site) will also be examined. If these analyses reveal meaningful between-group differences, such characteristics will be treated as covariates. If we identify missing data in the analysis (e.g., logs, checklists, rapport), we will use Kelsey’s method strategies to remedy missing data [92]. Although we do not plan to perform extensive cost-benefit analysis, we will document implementation costs (e.g., personnel, training costs, home visits, and postage and handling). In addition to performing analytical tests to minimize the potential confounding effects of missing data, we will engage in evidenced-based research design (recruitment and retention) strategies to minimize the possibility of missing data, some of which include (1) closely monitoring research milestones and targets and ensuring that participants reach these with the help of a health educator with whom the participants have a good rapport; (2) limiting the amount of research burden; (3) keeping close contact with participants through the project coordinator or health educator; and (4) providing adequate and fair monetary incentives for participating in the research study.

Participants will be randomly assigned to either the intervention arm (partnered with a peer health educator who received the culturally and linguistically tailored sleep health education and was trained for 8 weeks) or the attention-control group (the comparative group where participants are partnered with a peer health educator who did not receive tailored sleep health education but only standard health training for a 1 hour session). The unit of randomization is the participant and thus the unit of analysis will be at the participant level. All study staff except for the data manager and project coordinator will be blinded to participant assignment. The data manager generates the randomization sequence for each eligible participant and the study coordinator randomly assigns peer health educators to participants assigned to treatment and attention-control groups. We will un-blind participant assignment only in cases where the participant’s health is at risk due to CPAP usage (Fig. 3).

The research staff will conduct an 8-day home study to collect sleep data via actigraphy (ActiGraph WGT3X-BT monitor) and a daily sleep diary, as well as environmental influences of sleep, such as noise and temperature, two factors that may confound sleep duration and quality. On day 1 of home sleep, a study technician will visit the participant’s home to place the ActiGraph watch on the participant’s wrist as well as connect a sound device and thermometer to capture the participant’s physical sleep environment. During the visit at the participant’s home, staff will demonstrate how the WatchPAT™ home sleep test device is used, worn on the wrist and fingertip on the last night of a 7-day sleep diary. On the seventh day of the home evaluation, the study’s technician will re-visit the participant’s home to set-up a device, the WatchPAT™ portable sleep test device to determine the severity of OSA risk. The WatchPAT™ is an in-home device utilized for OSA evaluation cleared by the Food and Drug Administration and approved by the Center for Medicare & Medicaid Services [93, 94]. It measures blood oxygen saturation, pulse rate, airflow, respiratory effort (a combined signal using pressure transducer sensing forehead venous pressure, venous volume by photoplethysmography), and snoring levels. Automated analysis of physiologic data yields OSA indices that reflect OSA risk, which is verified by a trained human scorer to ensure accuracy of signal interpretation. The device integrates physiologic, clinical, and anthropomorphic data to determine the presence and severity of OSA. Correlation between the WatchPAT 200 and PSG recordings was 0.96 using AHI with a 4% desaturation. Diagnostic sensitivity and specificity of in-home WatchPAT using AHI ≥ 15 (in the absence of OSA symptoms) are 0.85 and 0.91, respectively [93]. Based on Medicare guidelines [95], those with an AHI ≥ 10 will be referred for treatment (American Academy of Sleep Medicine guidelines) [96]. We chose this criterion to ensure that we reduce the rate of false negative results. In the 7-day sleep diary, participants will indicate (1) nap time and duration, (2) medications/drugs promoting night-time sleep or daytime alertness (e.g., caffeine), (3) time to bed, (4) time of lights off, (5) final time of awakening, (6) final time of arising, and estimated (7) sleep latency, (8) sleep duration, (9) wake after sleep onset, (10) sleep quality, and (11) daytime sleepiness. On day 8, the study staff will retrieve all devices and data from the sleep diary.

After the home sleep study, the study staff will provide the results to the study physician to determine the risk of sleep apnea from the WatchPAT™ home sleep recorder device. The study physician will discuss the home study results with all participants and will recommend treatment to those meeting OSA diagnostic criteria (AHI > 10). Participants who do not meet OSA diagnostic criteria will be transferred to the project coordinator either for study close-out since they no longer need to continue their participation in the study, for future clinic-based diagnostic assessment, or for treatment customization. Participants who are at risk for OSA will be referred for further diagnostic assessment and treatment to a sleep clinic accredited by the American Academy of Sleep Medicine. Expenses incurred from laboratory and CPAP procedures recommended by sleep clinicians in our catchment area will be billed directly to the participant’s insurance. In the rare instance that a participant might fail to obtain insurance, the study project will absorb some medical costs and a CPAP device will be dispensed as an in-kind contribution.

Participants who have a high AHI (≥ 10) will be referred for sleep assessment to determine OSA diagnosis and appropriate treatment. Peer health educators will support participants as they navigate this phase of their care by helping them with scheduling appointments and occasionally accompanying them to appointments if requested by the participant, as well as providing general information about the sleep assessment. The purpose of this level of social support is to demystify the OSA assessment (which includes self-report screener, home study, and clinic study using polysomnography) experience, which can be daunting and might deter participants from undergoing the sleep assessment. In our previous research, we found that blacks were less likely to adhere to recommended OSA treatment and therefore the use of peer health educators is a practical way of increasing CPAP adherence.

At the end of the 12 month enrollment in the study, all participants will be debriefed by the project coordinator. Participants will complete the same baseline questionnaires and additional questionnaires designed to understand why participants adhered to the intervention and how the intervention might be refined to be more effective.

All participants’ data and patient health information will be confidential and protected during and after the trial. A code will be used to identify study participants, which will not be given to anyone outside of the study staff unless required by law. All paper records are stored in an area with two locked doors and/or drawers. Only the study staff will have access to the locks. All computerized records are password protected available only to the study team. We will use a data monitoring committee independent of the funding source to provide oversight on integrity of the collected data. We will perform yearly audits to ensure that study protocol is followed.

Sensors used for the sleep study recordings may cause minor skin irritation among people with sensitive skin; this does not usually require medical attention. Such irritation can easily be resolved with over-the-counter ointment that can be obtained at a local drug store. Participants may not directly benefit from being in this study. However, possible future benefits include increased awareness and learning about sleep apnea and receiving treatment for sleep apnea among those with an OSA diagnosis. If participants experience any harm due to participating in the study, we will follow all New York University ethical review board guidelines, which include (1) ensuring medical safety of participants by providing any medical treatment needed; (2) investigating the incident, determining if risk is inherent to study procedures, and submitting an adverse event report to the New York University ethical review board; and (3) making necessary updates to the protocol and notifying currently enrolled participants about the given risk.

The current trial and aforementioned procedures were approved by the New York University School of Medicine Institutional Review Board. Any changes to the protocol will need to be approved by the Institutional Review Board and the enrolled participants and funder will be notified. At the completion of data collection, the principal investigator and data analyst will process and analyze the data. Findings will be disseminated to the communities from which participants were recruited as well as to the funder. The data will be made publicly available 5 years after completion.

We conducted a feasibility study using OSA screening tools among blacks at the community level to provide (1) estimates of the likely rates of OSA in the community, which will in turn guide our recruitment strategies, (2) an empirical basis for our sample size calculations, and (3) preliminary evidence that education and support offered by a peer health educator led to OSA evaluation among blacks at risk.

Over a 15-day period, we randomly assigned 27 blacks to an intervention group (peer health educator) and 25 to a control group (publicly available sleep brochures and literature). The desired behavior was limited to ‘making an appointment for an OSA assessment’. Analysis showed that 26% of blacks in the control condition made an appointment for OSA assessment, whereas 41% of those exposed to the intervention arm made an appointment. Although results were in the expected direction, we were unable to determine whether participants would show up for OSA assessment and/or adhere to treatment. This requires long-term monitoring and justifies the purpose of our study.

We plan to screen approximately 1250 blacks in the community. Assuming 39% of blacks are at risk for OSA, we propose to enroll 398 men and women (199 per study arm). With a 35% attrition rate, 258 will have provided adherence data during 6-month follow-up assessment. Based on the pilot data, we expect that 41% in the intervention arm (n = 82) and 26% in the attention-control arm (n = 52) will have completed all aspects of the trial, including site interview, home evaluation, and follow-up assessment (Fig. 2).

The primary study outcome is receipt of home OSA evaluation after tailored peer-based sleep health education. Data obtained from a sample of blacks provided a current estimate of the likely OSA evaluation rate we expect in the partner community. Analysis showed that 41% of participants adhered to recommended OSA evaluation after intervention exposure, whereas 26% of participants in a control group agreed to undergo evaluation. These preliminary findings represent the likely adherence rates expected in our proposed study.

We propose to achieve an evaluation rate in our intervention arm of 41% based our pilot study mentioned above. This would represent a 63% greater adherence rate compared with controls, which potentially would have a significant public health impact. Assuming a 15% increase in the likelihood of undergoing home-based OSA evaluation, a standard error of 0.09% and a sample size of 398, the study will be adequately powered (> 85%) to detect a significant increase in adherence. Specifically, an observed difference of 15% would be reported with a 95% CI 7–24%. A two-tailed test, with 80% power and α = 0.035 comparing adherence rates of 26% with 41% requires 199 participants per group. Of note, our sample size estimate adjusted for potential intra-cluster coefficient that may be observed in both the treatment and control arms, which according to our initial pilot was 0.014. The resulting effective sample size (ESS = [M x K/DE]) after adjustment for design effect (DE)… [DE = 1 + (n-1)ρ] was n = 398 (199 participants per arm) [97, 98]. The study is also powered to assess differences in adherence rates to CPAP treatment between the two arms considering the likely attrition rate of 35% during follow-up assessment.

To describe sample characteristics, we will use measures of central tendencies and dispersion for continuous data; frequency distributions will be used for categorical data. We will use χ² tests to compare categorical data and GEE to examine relationships between predictors of adherence to OSA evaluation and/or treatment. The main dependent measure will be adherence to OSA evaluation (yes vs. no) and adherence to CPAP treatment (yes vs. no). Effects of sociodemographic and clinical factors will be adjusted. MANCOVA will be used to assess differences between baseline and 6- and 12-month subjective measures (e.g., self-efficacy, apnea knowledge, functional outcomes in sleep). Structural Equation Modeling will be used to examine the path toward adherence to OSA evaluation and/or CPAP treatment, considering the contributions of candidate factors.

It is likely that participants from the current study may be eligible for related ancillary studies. In such cases, only participants who endorsed being contacted for future studies will be contacted about ancillary studies. The study team will determine whether involvement in an ancillary study will interfere with the current study. If the ancillary study will interfere, we will defer enrollment until the participant is finished with all study procedures of the parent study. It is also likely that participants may be contacted about future studies after participating in the study. We will only contact participants who requested to be contacted.