Effortstoimprovemedicationnon-adherence(MNA)andbloodpressure(BP)controlinpatientswith hypertension(HTN)havemetwithlimitedsuccess.Innovativeapproachesareneededthatareacceptable, sustainable,efficacious,andeasilydisseminated.Therehavebeennorandomizedcontrolledtrials(RCTs) evaluatingtheapplicationoftheory-driven,patientcentered,mobilehealth(mHealth)technologyprograms amongAfricanAmericans(AAs)withMNAanduncontrolledHTN.Theproposedresearchwilltestandrefine theSmartphoneMedicationAdherenceStopsHypertension(SMASH)program.SMASHincludesmulti-level components:1)automatedremindersfromanelectronicmedicationtray;?2)tailoredtextmessage/voicemail motivationalfeedbackandreinforcementguidedbyself-determinationtheoryandbaseduponadherenceto dailymedicationandBPmonitoringand3)automatedsummaryreportsanddirectalertstoproviders.A6- month,2-arm(SMASHvs.enhancedStandardCare[SC])efficacyRCTwillbeconductedin192AAs(21-59 yearsold)withelectronicmonitorderivedMNAandrepeatedclinicand24hrBPverifieduncontrolledHTN. Evaluationswilloccuratbaseline,months3and6,andpost-trialfollow-upsatmonths12and18.
Specificaims aretotestthehypothesesthat,comparedtotheenhancedSCcohort,theSMASHcohortwilldemonstrate significantlyimprovedandsustainedchangesin:1)PrimaryOutcomeVariables:a)Medicationadherence:% withelectronicmonitor-derivedadherencescores>0.90;?b)BPcontrol:%meetingJNC8guidelinesforBP control(restingBP<140/90mmHg).2)SecondaryOutcomeVariables:a)%reachingandsustaining24-hr ambulatoryBP<130/80mmHg;?b)%ofprovideradherencetoJNC8guidelinesasmeasuredbytimingof medicationchangesandc)patientchangesinSelf-DeterminationTheoryconstructs(e.g.,competenceand autonomousmotivation).3)ExploratoryOutcomes:a)moderators(e.g.,gender,age,income)andmediators (e.g.,perceivedseverityofdisease,medsideeffects,depressionsymptoms,etc.)ofmedicationadherence andBPcontrol;?b)costeffectivenessandc)physicalriskfactorchanges(cholesterol,LDL,HgA1c,blood glucose).Afterfinalfollow-upevaluations,focusgroupswithrandomsampleofSMASHsubjects(totaln=32) andhealthcareproviders(totaln=~12)willassesskeyuserreactionsincludingacceptability,usability,salience andaids/barrierstosustainability.DatafromRCTandfocusgroupswillbetriangulatedtofurtherrefineand optimizeSMASHandprepareforamulti-siteeffectivenessRCT.Ourlong-termobjectiveistoreduce prematuremortalityamongAAsbydevelopingeffectiveandsustainablemHealthchronicdiseasemedical regimenself-managementprogramsincludingmedicationadherence,bio-functionmonitoring(e.g.,BP)and timelybidirectionalcontactwithhealthcareproviders.
Interventionsthataddressmedicationnonadherenceamongchronicdiseasepatientsmustbeacceptable, sustainable,andeasilydisseminatedbyclinicians.Wewilltestandfurtherrefineasmartphonedelivered, tailoredmedicalregimenself-managementprogramforAfricanAmericanswithuncontrolledhypertensionthat willfacilitatemedicationadherence,BPcontrol,andclinicianoversight.Withdemonstratedeffectivenessin futuretrials,theinterventionwillamelioratetheriskoffuturecomorbidities(e.g.,hypercholesterolemia, diabetes),cardiovascularevents(e.g.,kidneyfailure,stroke,heartattack)andassociatedprematuremortality.
