Girardin Jean-Louis|Rebecca Robbins|Natasha Williams|John P. Allegrante|David M. Rapoport|Alwyn Cohall|Gbenga Ogedegbe
Tailored Approach to Sleep Health Education (TASHE): a randomized controlled trial of a web-based application
New York University|Brigham and Women's Hospital|Harvard University|Columbia University|Icahn School of Medicine at Mount Sinai|Columbia University
free accessscientific investigationstailored approach sleep health education tashe randomized controlled trial webbased application girardin jeanlouis phd rebecca robbins phd natasha j williams edd mph john p allegrante phd david rapoport md alwyn cohall md gbenga ogedegbe md girardin jeanlouis phd department population health center healthful behavioral change nyu grossman school medicine new york new york department psychiatry nyu grossman school medicine new york new york rebecca robbins phd brigham womens hospital boston massachusetts harvard medical school boston massachusetts natasha j williams edd mph department population health center healthful behavioral change nyu grossman school medicine new york new york john p allegrante phd columbia university teachers college new york new york columbia university mailman school public health new york new york david rapoport md icahn school medicine mount sinai new york new york alwyn cohall md columbia university mailman school public health new york new york gbenga ogedegbe md department population health center healthful behavioral change nyu grossman school medicine new york new york published onlineaugust 15 2020httpsdoiorg105664jcsm8510cited by4sectionsabstractpdf shareshare onfacebooktwitterlinkedinredditemail toolsadd favoritesdownload citationstrack citations aboutabstractstudy objectivesin randomized controlled trial compared effect tailored approach sleep health education tashe obstructive sleep apnea osa selfefficacy among communitydwelling blacks new york citymethodsstudy participants 194 blacks high risk osa based apnea risk evaluation system tashe intervention delivered via wifienabled tablet programmed provide online access culturally linguistically tailored information designed address unique barriers osa care among blacks blacks attentioncontrolled arm received standard sleep information via national sleep foundation website blacks arms accessed online sleep information 2 months outcomes osa health literacy selfefficacy knowledge beliefs sleep hygiene assessed baseline 2 months 6 monthsresultswe compared outcomes arms based intentiontotreat analysis using adjusted generalized linear mixed modeling tashe exposure significantly increased osa selfefficacy osa outcome expectation 5 95 ci 19 osa treatment efficacy 04 95 ci 08 2 months 6 months additionally tashe exposure improved sleep hygiene 6 months 67 95 ci 22113 2 monthsconclusionscommunitydwelling blacks exposed tashe materials reported increased osa selfefficacy compared standard sleep health education stakeholderengaged theorybased approaches demonstrated tashe intervention used successfully deliver effective sleep health messagesclinical trial registrationregistry clinicaltrialsgov url httpsclinicaltrialsgovct2shownct02507089 identifier nct02507089citationjeanlouis g robbins r williams nj et al tailored approach sleep health education tashe randomized controlled trial webbased application j clin sleep med 202016813311341brief summarycurrent knowledgestudy rationale blacks twice likely whites risk obstructive sleep apnea osa associated adverse health outcomes despite disparities interventions aimed osarelated morbidity mortality among blacks limitedstudy impact study evaluated novel webbased educational tool designed address specific barriers access adequate osa care among blacks risk osa paper report results randomized controlled trial evaluated effectiveness tailored sleep health messages versus nontailored messages among communitydwelling blacks risk osaintroductionobstructive sleep apnea osa significantly increases risk hypertension1 cardiovascular diseases2 diabetes3 evidence shows individuals untreated incur higher health care costs relative treatment4 light evidence national academy medicine national institutes health recognize osa chronic disease requiring novel strategies increase adoption evidencebased treatment reduce osarelated morbidity health care costs5 despite national recognition public health impact osa availability evidencebased therapies68 progress reducing osarelated morbidity mortality limited particularly notable among blacks experience disproportionate osa burden relative white counterparts910 characterized greater risks adverse osarelated health outcomes1112 poor adoption physicianrecommended sleep care13 likely strongest contributor greater osa burden among blacks114 rendering osa prime target behavioral intervention increase adherence recommended care vulnerable group15other factors including psychosocial influences also important understanding disparity osa prevalence among blacks135 evidence prior work suggested 38 blacks adhered physicianrecommended osa care13 line qualitative research conducted among black men showed exhibited low intention seek evaluation treatment osa16 indeed focusgroup data showed able identify symptoms osa knew consequences osa1617 even reported many false beliefs osa osa symptom insomnia osa bearing chronic metabolic conditions eg hypertension diabetes obesityefforts made address factors hindering adherence recommended osa care however attention paid mainly perceived benefits treatment1820 rather selfefficacy important predictor adherence recommended care according decades research applying banduras social cognitive theory21 converging evidence demonstrates individuals high level selfefficacy likely engage actionoriented healthful behavior speaking health care provider seeking physicianrecommended medical care2223 selfefficacy refers individuals belief ability perform recommended care tasks seeking adhering recommended osa evaluation treatment field sleep medicine2425 evident failure implement interventions increase selfefficacy among blacks risk osa may part liable observed undertreatment osa vulnerable population26consistent national institutes healths sleep disorders research plan seeking promote sleep health nationally developed tailored approach sleep health education tashe novel webbased educational tool deliver osa health messages communitydwelling blacks risk osa tashe materials designed provide culturally linguistically tailored sleep health information blacks assist navigating complex process making informed decisions regarding osa care paper report results randomized controlled trial rct evaluated effectiveness tailored sleep health messages improving osa selfefficacy among communitydwelling blacks risk osamethodsstudy design settingin 2arm rct tested effect tashe versus attentioncontrol osa selfefficacy among communitydwelling blacks new york city specifically administered validated questionnaires baseline compared responses 2 months 6 months postexposure test following hypotheses participants tashe condition demonstrate higher osa selfefficacy28 greater sleep apnea beliefs knowledge improved sleep hygiene29 higher osaspecific health literacy30 compared control conditionparticipants recruited communitybased settings including faithbased organizations community centers barbershops beauty salons individuals randomized receive either wifienabled preprogrammed tablet access tashe website intervention nontailored osa informational materials currently available national sleep foundation attention control participants asked review tabletdelivered information regularly received messages sent mobile device reminders review tashe website 2month period time asked come back study center return tablet surveys administered baseline 2 6 months27 participants provided written informed consent approved intuitional review board nyu langone healthparticipantsa total 524 potentially eligible individuals contacted recruited 194 met eligibility criteria enrolled study eligibility criteria included selfidentified black african american caribbean american 18 years age older moderate greater risk osa determined score 4 greater apnea risk evaluation system31 used previous studies involving blacks15 screening tool includes questions sleep patterns daytime functioning excessive daytime sleepiness snoring gasping height weight neck size sex diseases associated risk osa ie hypertension heart disease validity well documented sensitivity of94 specificity of79 positivepredictive value of9132 met study selection criteria randomized treatment groups immediately screening randomization accomplished computergenerated randomization paradigm figure 1 shows flow participants study protocol using consort consolidated standards reporting trials diagram tashe website featured culturally linguistically tailored sleep informational content including texts videos developed align needs blacks decrease cognitive load render messages understandable actionablefigure 1 consort diagram outlining flow participants tashe studyconsort consolidated standards reporting trials tashe tailored approach sleep health educationdownload figuremeasuresparticipants completed surveys captured demographic clinical characteristics addition psychosocial sleeprelated factors baseline 2 months 6 months postenrollmentdemographic health variablesparticipants provided responses demographic questions including age sex education income marital status health insurance asked whether received diagnosis chronic health conditions including medical psychological illnesses additionally administered center epidemiologic studiesdepression scale short selfreport scale designed measure depressive symptomatology general population33our primary outcome measure osa selfefficacy secondary outcomes included osa risk health literacy knowledge beliefs well sleep hygieneosa selfefficacyosa selfefficacy assessed using 26item sleep apnea self efficacy semsa scale28 participants asked respond series statements regarding confidence using recommended osa treatment includes using positive airway pressure pap device sleep night despite certain challenges travel disturbing bed partner nasal stuffiness using 4point scales validity true true responses averaged 3 cognitive subscales including perceived risk osa eg extent participant believes risk osa pap outcome expectations eg osa conditions improve yield desirable benefits improved quality life treatment efficacy eg extent participant believes treatment improve condition lower responses indicated lower osa selfefficacyosa health literacyosa health literacy assessed newly developed sleep apnea health literacy scale sahls validated scale assessing knowledge osa symptoms treatment maintenance30 sahls contains 15 items examined literacy regarding osa treatment symptoms participants marked responses 3point scales based statements ranging 1 certain true 2 sure 3 certain true responses summed provide single score osa health literacy scale whereby higher scores indicated higher literacy levelsosa riskosa risk measured validated apnea risk evaluation system scale31 assesses osa risk factors including chronic conditions neck size drowsiness various daily activities eg lying afternoon 4point scale drowsiness snoring eg often snored 4point scale frequency sleep hygiene practices examined using sleep hygiene index shi 13item scale assessing unhealthy sleep practices responses summed indicate global assessment poor sleep hygiene responses collected 5point scale high scores indicating worse sleep hygieneosa knowledge beliefsthe validated apnea knowledge test akt34 utilized assess knowledge beliefs questionnaire designed assess respondents knowledge osa treatment using pap based 13 multiplechoice items high akt scores indicated better knowledge osa treatment lower scores indicated poor understanding osa pap second osarelated beliefs examined using validated apnea belief scale abs34 questionnaire includes 24 statements evaluated patients beliefs osa pap treatment34 scores abs range low 24 high 120 high abs scores indicate accurate beliefs illness treatment lower scores indicate misconceptions osa pap usageinterventionsour previous research revealed several barriers osa care used develop sleep health information webbased educational tool1315 messages embedded tashe written fifth sixthgrade reading level determined flesch kincaid reading ease formulas3536 messages also included visuals eg pictures videos intentionally featured black role models addressing various aspects osa care delivery ensure high degree congruence intended audience thus tashe website unique delivering osa materials blacks manner enhanced acceptability messages autonomous decision makingtashe messages developed within health literacy framework using criteria suitability assessment materials accordingly messages drafted way minimizes use jargon decrease cognitive load37 messages also developed based established messagetailoring strategy requiring video content consistent previous research advocates messages reflect realities patients living similar communities38 perhaps importantly content tashe website developed using stakeholderengaged process including patients osa community health champions health care providers figure 239 communityengaged method considered effective approach develop health interventions address health disparities40figure 2 multilevel communityengaged model developing tashe interventionnyu new york university tashe tailored approach sleep health educationdownload figurewe performed heuristic testing solicit feedback communitydwelling blacks ensure intervention sufficiently appropriately tailored needs easy understand use indepth interviews conducted heuristic testing accordance think aloud oneonone interview protocol39 participants randomized tashe arm received wifienabled preprogrammed tablet prompted review materials tablet within first week randomization results heuristic testing supported approach utilization webbased tool results also enabled final design changes eg addition locationenabled map identify nearby sleep clinics39 prior deployment clinical trial described hereinparticipants rct asked review materials weekly 2 months returning research office complete followup assessments illustrations tashebased materials provided figure 3 details study design found elsewhere27 individuals randomized attentioncontrol arm exposed nontailored websites included online resources national organizations eg national sleep foundation previous studies suggested health information websites largely feature content 10thgrade reading level41figure 3 screenshots tashe website intervention materialstashe tailored approach sleep health educationdownload figurestatistical analysesall data collected baseline 2 6 months postenrollment study demographic factors compared tashe control using appropriate statistical test either chisquare analysis variance anova sleep osa outcomes compared intervention control arms using repeatedmeasures anova greenhousegeisser correction f values primary outcome semsa secondary outcomes assessed time point conducted intentiontotreat analyses mixedeffects linear modeling robust estimation model effect exposure tashe intervention compared data control arm time baseline 2 months 6 months outcome variables tested 3 separate models 1 unadjusted 2 age sex adjusted 3 remaining covariates including income employment marital status depression osa risk factors eg alcohol consumption smoking history data analyzed using spss version 25 ibm corporation armonk nyresultswe recruited 194 individuals 304 lost followup arms see consort flow diagram figure 1 overall significant differences demographic characteristics participants 2 study arms baseline similarly participants differ regard selfreported health status physiciandiagnosed chronic health conditions table 1table 1 participant baseline characteristics total group assignmentvariabletotal n 194control n 98intervention n 96pnnnage486 1409489 1375484 1443814sex956 male904764647444478 female995245152648522raceethnicity281 black1941000981000961000education465 high school583813120327178 college422762617116105 technical school certificate852426426 associate degree1492959533 bachelors degree171116391172 graduate professional school1385746639employment050 employed654334150024353 unemployed855674150044647income564 10000452942516320131 1000019999332161610517111 20000399992617018118852 4000059999221449591385 60000100000181181172746 100000959320639marital status655 marriedliving partner35230221451386 separated959533426 widowed959320639 never married1386639746 divorced171121066746 single694543825031204health insurance private352191920716235622 medicare342131618418265654 medicaid714444450627397015 hmo744669115058 military veterans213223000160 none1169557688728chronic conditions hypertension764203418842232085 diabetes32178147818100214 depression583262715231174246 anxiety583242916229162419 heart problems3419217961796459 sleep apnea553152614929166216selfreported health112 excellent1373845528 good533002916424136 good593332514134192 fair482712815820113 poor422211211depression cesd179 114181 117176 109340 apnea risk evaluation system osa risk458 mild6339132198831193 moderate5936628173931193 severe3924221130418112n 194 p values reported correspond appropriate statistical test including either anova chisquare anova analysis variance cesd center epidemiologic studiesdepression hmo health maintenance organization osa obstructive sleep apneavalues represent means sdstable 2 displays selfreported outcome measures participants tashe attentioncontrolled arms baseline 2 6 months postrandomization according repeatedmeasures anova sahls scores vary significantly condition f 92 p 642 shi scores vary significantly condition f 85 p 410 apnea belief scores vary significantly condition f 67 p 110 apnea knowledge scores vary significantly condition f 93 p 684 semsa risk vary significantly condition f 74 p 105 semsa outcome expectations vary significantly condition f 57 p 001 semsa treatment expectations vary significantly condition f 91 p 585table 2 comparing selfreported sleep outcome measures captured baseline 2 6 months using repeatedmeasures anovasleeprelated outcomesbaseline2 months6 monthsf p valuesahls92 642 intervention118 76157 58163 74 control137 65163 60168 46shi85 410 intervention204 96179 98198 84 control221 96187 99150 91abs67 110 intervention622 217697 162649 238 control618 251600 253623 212akt93 684 intervention27 1933 1834 17 control28 1732 1836 17semsa risk perception74 105 intervention22 0724 0726 08 control23 0725 0824 08 outcome expectation57 001 intervention25 0930 0731 09 control27 0729 0832 07 treatment efficacy91 585 intervention22 0926 0727 07 control25 0826 0929 10values means sds unless otherwise indicated n 194 p values reported correspond repeated measures anova abs apnea belief scale akt apnea knowledge test anova analysis variance sahls sleep apnea health literacy scale semsa selfefficacy measure sleep apnea shi sleep hygiene inventoryeffect intervention primary outcomessemsaas shown table 3 compared control condition significant positive effect intervention outcome expectation dimension semsa scale 2month assessment period model 1 05 95 ci 01 09 adequate adjustment age sex effects similar results obtained responses measured 2 months adjusting demographic covariates model 2 07 95 ci 03 11 significant positive effect intervention exposure noted treatment efficacy dimension osa selfefficacy 2 months controlling demographic factors model 1 04 95 ci 00 08 additional covariates including depression marital status income depression employment alcohol consumption 06 95 ci 01 11table 3 mixedeffects modeling intervention effect sleep outcomesmodel 1model 295 ci95 cilowerupperloweruppersahls intervention time 2 months1023437317130 intervention time 6 months243988320873shi intervention time 2 months092744172862 intervention time 6 months6722113302685abs intervention time 2 months94091979523214 intervention time 6 months28901463188149akt intervention time 2 months010608030511 intervention time 6 months021108061704semsa risk perception intervention time 2 months010204010305 intervention time 6 months020206020306 outcome expectation intervention time 2 months050109070311 intervention time 6 months020307020307 treatment efficacy intervention time 2 months040008060111 intervention time 6 months010406010507n 194 model 1 adjusted age sex covariates model 2 adjusted model 1 plus additional covariates including marital status income depression employment alcohol consumption abs apnea belief scale akt apnea knowledge test ci confidence interval sahls sleep apnea health literacy scale semsa selfefficacy measure sleep apnea shi sleep hygiene inventorysignificant p 005effect intervention secondary outcomesthere significant difference tashe attentioncontrolled arms apnea knowledge apnea beliefs scores results mixedeffects model revealed significant positive effect intervention several sleep measures first compared participants control arm intervention arm demonstrated significant increase shi 6 months controlling age sex model 1 67 95 ci 22 113 however effect longer significant adjusting marital status income employment depression alcohol consumption smoking history difference sahls tashe control armsdiscussionin study developed tested effectiveness webbased tool referred tashe main finding rct exposure tashe materials associated significant increase selfefficacy 2 months measured semsa however effect sustained 6 months specifically observed significant positive effect osa outcome expectation treatment efficacy 2 months postexposure analyses secondary outcomes showed participants exposed tashe materials exhibited significant improvement sleep hygiene independent participants sex age however results significant adjusting marital status household income employment status alcohol consumption presence depressionthese findings consistent extant literature showing selfefficacy strong predictor likelihood individuals engage desired behavior change health practices21 study showed positive effect outcome expectation treatment efficacy dimensions semsa scale constructs similar notion perceived benefits finding congruent previous research shown perceived benefits osa treatment associated increased adherence behavior1820 utilization osa selfefficacy study enables direct contrast evidence based observations fields study indeed metaanalysis 79 rcts showed behavioral interventions improved selfefficacy among patients cancer42 evidence also suggests selfefficacy important construct understanding behavior change among patients cardiovascular disease43 present study addressed important gap sleep field relates lack systematic studies investigating effects behavioral educational programs improving osa selfefficacy care although evident individuals risk osa routinely seek osa care4445 notwithstanding worth noting systematic review highlighted creative strategies could used increase adherence recommended osa care46 one behavioral intervention showed improvement osa selfefficacy leading increased use positive airway pressure therapy47 yet none published studies designed specifically increase osa care among blackafricanamerican populations thus study makes significant contribution field sleep medicine demonstrating usefulness tailored educational website improving osa selfefficacy among blacks group high risk osaresearch shown although blacks greater risk osa experience higher prevalence apnearelated morbidity4849 less likely seek osa care individuals racialethnic groups50 indeed 38 blacks referred sleep evaluation adhered physicianrecommended care13 available evidence also suggests blacks less likely adhere treatment recommendations6 thus finding increased outcome expectation treatment efficacy resulting exposure tashe intervention encouraging specifically higher beliefs treatment efficacy may increase willingness adhere recommended osa care eg pap moreover results strongly suggest blacks greater selfefficacy would likely engage osa helpseeking behavior attending scheduled sleep clinic visits13 adhering recommended osa evaluation treatment51 indeed previous trial among