grant

Testing the Pain Relief of musculOskeletal conditions and Arthritis using Carefully Tailored InterVEntions (PROACTIVE) Intervention: A Randomized Controlled Trial

Organization UNIVERSITY OF FLORIDALocation GAINESVILLE, UNITED STATESPosted 1 Jun 2024Deadline 31 Mar 2027
NIHUS FederalResearch GrantFY202621+ years oldAcuteAddressAdultAdult HumanAffectAgeAgingAnalgesic AgentsAnalgesic DrugsAnalgesic PreparationAnalgesicsAnodynesAntinociceptive AgentsAntinociceptive DrugsAreaArthritisAttenuatedBackBehaviorBody TissuesCaringCharacteristicsChronicClinicalCommunitiesControl GroupsCoping SkillsCounselingCounselorCoxaDecline in mobilityDecrease in mobilityDecreased mobilityDemographic FactorsDiminished mobilityDisablementDisablingDisparitiesDisparityDorsumEcological momentary assessmentEconomic BurdenEconomicsEducationEducational MaterialsEducational aspectsEffectivenessEnrollmentFaceFaithFamilyFeasibility StudiesFemaleFinancial HardshipFinancial SupportFundingHealthHealth CareHealth Care CostsHealth CostsHealth InsuranceHealth Insurance for Aged and Disabled, Title 18Health Insurance for Disabled Title 18HipHip region structureHourHyperalgesiaHyperalgesic SensationsImpoverishedIndividualInequalityInsuranceInsurance BenefitsInterventionIntervention TrialInterventional trialJointsKneeKnowledgeLeadLearningLiteratureLow incomeMeasuresMediatingMediatorMedicareMental HealthMental HygieneMobility declineMobility impairmentModelingMovementMusculoskeletalNIAMSNSAIDsNational Institute of Arthritis, and Musculoskeletal, and Skin DiseasesNon-Steroidal Anti-Inflammatory AgentsNursesOutcomeOutcome AssessmentPainPain ControlPain TherapyPain intensityPain interferencePain managementPain qualityPainfulParticipantPatternPb elementPersonsPhysical FunctionPhysical PerformancePopulationPovertyPrayersProfessional counselorPsychological HealthPsychosocial FactorPublic HealthRandomized, Controlled TrialsReduced mobilityReduction in mobilityReportingResearch ResourcesResourcesRestRiskSelf ManagementSeminalSeveritiesSingle-Blind StudySingle-blindSocietiesSourceSpiritualityTechnologyTestingTimeTissuesTitle 18TrainingVeteransWalkingWorkadulthoodagesarthriticattenuateattenuatesbehavior changebody movementchronic MSK painchronic musculoskeletal paincommunity interventioncommunity level interventioncommunity-based interventioncompare interventioncomparison interventioncopingcoping strategycostdaily paindesigndesigningdetermine efficacydisabilityecological momentary interventioneconomiceconomic hardshipeconomic needeconomic straineffective interventionefficacy analysisefficacy assessmentefficacy determinationefficacy evaluationefficacy examinationenrollevaluate efficacyevidence baseexamine efficacyexperiencefacesfacialfinancial adversityfinancial aidfinancial assistancefinancial burdenfinancial distressfinancial insecurityfinancial instabilityfinancial literacyfinancial strainfinancial stressfinancial worryhealth care servicehealth insurance for disabledhealth insurance planhealth literacyheavy metal Pbheavy metal leadhigh riskhigh risk grouphigh risk individualhigh risk peoplehigh risk populationhyperalgiaimprovedinnovateinnovationinnovativeintervention effectintervention refinementlater in lifelater lifeliteracymaleneglectnon-steroidal anti-inflammatory drugsnovelnurseold ageolder adultolder adulthoodopiate consumptionopiate drug useopiate intakeopiate useopioid consumptionopioid drug useopioid intakeopioid usepain interventionpain killerpain medicationpain reductionpain reliefpain relieverpain self-managementpain treatmentpainkillerperceived stressperception of stresspost interventionpreferenceprimary end pointprimary endpointprimary outcomeprototypepsychosocialpsychosocial variablesrandomized control trialreduce painrelieve painsecondary outcomeself-reported stresssexskillssmart watchsmartwatchsocialsocio-economicsocio-economicallysocioeconomicallysocioeconomicsstress perceptiontoolusual care armusual care control group
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Full Description

Chronic musculoskeletal conditions and their primary source of pain, movement-evoked pain (MEP), causes
significant pain interference, long-term mobility impairment, healthcare costs, and psychosocial inequalities for

individuals, families, communities, and society-at-large. MEP affects more adults in later life and is perceived

as more severe than resting pain. Many older adults hesitate to use opioids and non-steroidal antiinflammatory

drugs long-term and rely on non-pharmacological pain self-management (SM) strategies. Current

studies of chronic musculoskeletal pain (CMP) SM interventions do not measure MEP as a primary endpoint

nor address faith/spirituality, varied traditions, and underlying potentially modifiable health indicators (e.g.,

health literacy, financial hardship), and therefore only offer small or no benefit over control conditions. We

propose to enhance older adults’ capacity to manage MEP by investigating the effects of a tailored pain SM

intervention (Pain Relief for musculOskeletal conditions and Arthritis using Carefully Tailored InterVEntions

[PROACTIVE]). This prototype intervention will provide focused pain SM education with a SM resource toolkit,

active prayer, and financial counseling to explain participants’ healthcare benefits for pain care. This

intervention moves beyond basic tailoring and targets multiple areas for behavior change that are of

importance to adults in later life. We have assembled an interdisciplinary and clinically experienced team to

lead this study. We will enroll 120 adults (age 50-92 years) with CMP into a parallel group, single-blind,

randomized controlled trial to test whether PROACTIVE decreases MEP (primary outcome) in the immediate

post-intervention period (n= 60) (Aim 1) and over time (Sub-Aim 1a) compared to a usual care control group

(n= 60). To determine efficacy, we will use state-of-the-art and real-time technologies to measure MEP as well

as pain interference, pain coping, and physical function (secondary outcomes) (Sub-Aim 1b). The PROACTIVE

group will work with a nurse and financial counselor over four weeks to enhance knowledge of CMP SM,

utilization of active prayer and faith, and financial literacy of health insurance benefits and resources available

to cover treatments for pain. Each weekly session will last up to 2 hours and will be followed by six days of

ecological momentary assessments of pain and SM outcomes and ecological momentary interventions guiding

participants through weekly SM skills. A fourth booster session will reinforce content and training and help

sustain SM. Also, we will examine the differential effects of PROACTIVE on MEP according to demographic

and psychosocial factors (Aim 2). The proposed intervention is expected to produce meaningful reductions in

MEP in aging adults experiencing disabling chronic musculoskeletal conditions. Ideally, this study will identify

precision behavior targets and responders to inform intervention refinement.

Grant Number: 5R01NR021183-03
NIH Institute/Center: NIH

Principal Investigator: Staja Booker

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