The Lifestyle Redesign Intervention
The Lifestyle Redesign Intervention:The Design Process & Evidence for EffectivenessDr. Florence Clark, PhD, OTR/L, FAOTA
Aging, Health, and Chronic Disease
What's the big deal? Chronic disease Disability PreventionImage from: pg
Health and AgingMedicallyserious comorbiditiesStress anddepressionPainAge-relatedchronicdiseaseslead to:ReducedactivitiesUnemployment
The Aging Global PopulationPercentage Change in the World Population by Agefrom 2010 to 20500-6422 65188 85351 1001004020040060080010001200
Living with Chronic Disease Chronic disease #1 global cause of death 2/3 Israeli adults have 2 or more chronic diseasesTop 5 Causes of Death (Israel, 2012)1. Cancer2. Heart diseases3. Cerebrovascular diseases (stroke)4. Chronic respiratory diseases5. Diabetes
WE BECOME WHAT WE HAVE DONE:AGING WELL
Aging Around the SardiniaSeventh-DayAdventistsOkinawan Secrets
Seventh-Day Adventists:Loma Linda, CALifestyle Factors–––––––Abstinence from tobacco, alcohol, caffeine, & other drugsLow stress lifestyleVegetarian diet and high level of spring water intakeWeekly day of rest on the SabbathRegular exerciseClose-knit family structurePrayer and worship within the church communityLife expectancy of Vegetarian Adventists: Male: 83.3 years Female: 85.7 yearsUS Average Life Expectancy 78.8 years
Early Health Habits haveLong Term ConsequencesDeficits in brain,cognitive, andbehavioraldevelopmentearly in life Cardiovasculardisease Stroke Hypertension Diabetes Obesity Smoking Drug use Depression
Two Different TrajectoriesEats abalanceddietChooses healthy,meaningful routinesand habitsExercises 5days/weekEats a diet high inrefined sugars andprocessed foodsAddsqualityyears to lifeIncreases BMI,Diagnosed withDiabetesDecreasesquality of lifeEngages in mostlysedentary activitiesReduces ability toparticipate inmeaningful activities
“What we need are innovativesolutions to stop people from gettingsick in the first place and policies toprovide people with the opportunityto lead healthier lives.”- Risa Lavizzo-Mourey, M.D., M.B.A., president &CEO of the Robert Wood Johnson Foundation
The USC Well Elderly StudyResearch Program (WE)
Process of ConductingTranslational ResearchResult:– Build theory– Demonstrate treatment effectiveness and costeffectiveness
Translational Research BlueprintStep 1: Identify problem Step 2: Develop theoreticalunderstanding of the problem Step 3: Develop intervention Step 4: Test intervention efficacy (RCT) Step 5: Evaluate cost-effectivenessStep 6: Test interventioneffectiveness (RCT) Step 7: Study theoretical model forwhy outcomes were produced Step 8: Knowledge translation,transportation, and dissemination
Funding for Translational ResearchGrant TitleFundingAgencyAward #AmountYearsHealth Mediating Effects of theWell Elderly ProgramNIH/NIA#1 R01 AG02110801A2 2,247,18720042010The Effectiveness of TwoOccupational Therapy Treatmentsfor the Elderly (inc. MinoritySupplement)NIH/NIA &NCMRR;ACHPR;AOTF#R01 AG11810;#R01 AG1181001S1 926,89019941997Lifestyle Redesign for PressureUlcer Prevention in SCI (LR-PUPS)NIH/ NICHD/NCMRR#1 R01 HD05626701 2,865,31720082013 223,85220102011 467,85120002003LR-PUPS AdministrativeSupplementDaily Living Context and PressureSores in Consumers with SCISame asaboveDOE/ NIDRR#H133G000062Total: 6,731,097
Importance of RCTs Random allocation of participants to interventionor control group Both groups treated identically, except for theexperimental intervention Blinding:– Hypothesis blinding (interveners)– Condition blinding (testers) Strongest form of evidence for treatment effect
Overview Specific aims– To assess the efficacy, effectiveness and costeffectiveness of the Lifestyle Redesign intervention– To investigate the mediating mechanisms thataccount for its health outcomes– To build a robust data set for future secondaryanalyses by gerontological researchers
Lifestyle Redesign Intervention Lifestyle Redesign enables patients to design, practice,and ultimately enact a personalized, sustainable health-promotingdaily routine that is tailored to address CD risk factorsas well as promote health and well-being more generally Lifestyle focused (activity based) Group & individual sessions Goal: Assist each participant to develop– A personally feasible, healthy lifestyle– Sustainable within the fabric of his or her everyday routines
Evidence for the Distinct Value ofOccupational Therapy
Design ProcessQualitative studyIdentify domainsLiterature reviewIntervention design
USC Well Elderly 1 Study (WE1) TeamFlorence Clark, PhDRuth Zemke, PhDJeanne Jackson, PhDMichael Carlson, PhDLoren G. Lipson, MDStanley P. Azen, PhDJoel W. Hay, PhDBarbara J. Cherry, PhDDeborah Mandel, OTDKaren Josephson, MDOccupational TherapyOccupational TherapyOccupational TherapySocial PsychologyGeriatric MedicinePreventive Medicine, BiostatisticsPharmaceutical Policy & EconomicsCognitive PsychologyOccupational TherapyGeriatric Medicine
Randomized Controlled TrialThree experimental conditions– Occupational therapy (n 122)– Social control group(n 120)– No treatment control (n 119)(n 361)
WE 1 RCT DesignMonth115Occupational Therapy9InterventionFollowSocial Group ControlNo Treatment ControlFollowHealth Care Utilization Data CollectionIntervention: 38 group sessions up to 9 hours of individual sessions
0%2%4%8%10%14%16%Absence ofEmotion-BasedRole Limitations6%Physical Functioning8%Absence of Bodily PainGeneral Mental HealthSocial FunctioningAbsence of Health-BasedRole Limitations12%General Health6%VitalityWell Elderly Study 1:Intent-to-TreatOccupational TherapyControl4%2%
The Well Elderly Study: News Clips
Intervention Outcomes90% of thetherapeutic gainwas retained at6-month follow-upCost per QALY was 10,666 50,000 definedcost-effective interventions
USC Well Elderly Study 2Health Mediating Effectsof the Well Elderly Program2004-2008National Institute on Aging(R01 AG 021108-01A3)PI: Florence Clark,PhD, OTR/L, FAOTA
USC Well Elderly Study 2 TeamFlorence Clark, PhDJeanne Jackson, PhDStanley P. Azen, PhDChih-Ping Chou, PhDBarbara J. Cherry, PhDMaryalice Jordan-Marsh, PhDBrett White, MDDouglas Granger, PhDRobert Knight, PhDMichael Carlson, PhDRand Wilcox, PhDDeborah Mandel, MAJeanine Blanchard, MAOccupational TherapyOccupational TherapyPreventive Medicine, BiostatisticsPreventive MedicineCognitive PsychologyNursingFamily MedicineBiobehavioral Health, Penn StatePsychology, GerontologySocial PsychologyPsychology, StatisticsOccupational TherapyOccupational Therapy
Purposes of the Study Examine the mediating mechanismsresponsible for its positive effects Replicate our previous results on the positiveeffects of the Lifestyle Redesign intervention Extend focus from efficacy to effectiveness Build a robust data set
Examine the MediatingMechanisms
Theoretical Model of Well Elderly Study 1ImprovedPsychosocialand Physical HealthLifestyle RedesignIntervention?Gains Sustained SixMonths LaterCost Effective
Conceptual Model of Positive Effects ofLifestyle Intervention for Older PeopleHealthy ActivityInterventionStress-RelatedBiomarkersActive CopingSocial SupportPerceived ControlPerceived Physical HealthPsychosocial Well-BeingCognitive FunctioningPositive ReinterpretationBased Coping
Replicate Our Previous Results
Efficacy vs. Effectiveness Efficacy of an intervention: WE 1– Favorable conditions that maximize the experimental effect Effectiveness of an intervention: WE 2– Less tightly controlled– More realistic circumstances that characterize complex, real world settings Instantiation of effectiveness– Expanded the number and type of sites from 2 to 21– Treatment period reduced from 9 to 6 months– More African Americans and Hispanics At high risk for disparities
WE 2 Semi-Crossover DesignMonth16Group AInterventionGroup BControl1218FollowFollowGroup BInterventionFollowTested every 6 monthsIntervention: 26 group sessions Up to 10 hours of individual sessions24Follow
Intent-to-Treat Analysis
Well Elderly 2Intent-to-Treat DesignMonth16Group AInterventionGroup BControl12FollowGroup BIntervention1824FollowFollowTested every 6 monthsFollow
Well Elderly Study 2: Intent-to-TreatTreatment (n 187) vs. Control (n 173)0.030.030.040.030.020.030.03
Cost Effectiveness Cost per QALY was 41,485– 120,000 to 150,000 currently defines cost-effectiveinterventions
Secondary Analysis:Pre-Post Interventionfor Group B (Control)Month1612Group AInterventionGroup BControlGroup BIntervention1824
Secondary Analysis: Pre-Post InterventionGroup B (Control) Receive Intervention (n 137)Health-Related Quality of LifeLife Satisfaction - LSI-Z0.02Depression0.01- SF36V2Mental Health0.01VitalityBodily Pain0.030.05Role Physical0.03Composite: Mental 0.04- CES-DCognitionMemory - CERADImmediate Recall0.05Composite: Physical0.07Delayed RecallPhysical Function0.07RecognitionGeneral Health0.34Psychomotor Speed0.01Social Function0.15Visual Search0.31Role Emotional0.10 0.00010.01
Secondary Analysis: Pre-Post InterventionAll Participants Receiving InterventionMonth16Group AInterventionGroup BControlGroup BIntervention121824
Secondary Analysis: Pre-Post InterventionAll Participants Receiving Intervention (n 326)Health-Related Quality of LifeLife Satisfaction - LSI-Z.0005Depression - CES-D.001- SF36V2Mental Health.001Social FunctionVitality.05Bodily PainComposite: MentalComposite: PhysicalGeneral HealthPhysical FunctionRole EmotionalRole Physical.001.003CognitionMemory - CERAD.006Immediate Recall.002.007Delayed Recall.004.02Recognition.006.02.06Visual SearchPsychomotor Speedns .0001.01
A Feature Missed by Usual Methods
Summary of Robust WE2 Analyses Association between attendance and various changescores:– Low attendance: little or no association– Association appears as attendance increases Robust methods are important when assessing strengthof association and effect size Ethnic concordance: medium to large effect size for:––––Physical functionBodily painPhysical compositeImmediate recall
Robust Data Set Measurement– 17 paper & pencil questionnaires: Health-Related Quality of Life Perceived Physical Health Psychosocial Well-being– 3 Cognitive tests: Memory Visual Search Psychomotor Speed– Biomarkers: Blood Pressure Diurnal saliva sampling (Cortisol, DHEA, Alpha Amylase)
Robust Data Set Data Points– 1,517 Questionnaire and cognitive testings 433,128 data points– 1,155 Saliva samples, survey and blood pressure collected 39,270 data points– Lists of medications range from 0-31 for 1,155 participants
Conclusion Well Elderly Study 1 demonstrated the efficacy of a Lifestyle Redesign intervention Well Elderly Study 2 documented the effectiveness of a Lifestyle Redesign intervention– Applied to a sample of older adults at higher risk for experiencing health disparities– Implemented in diverse community settings– Delivered within a shorter time interval Cost-Effective Change in activity seemed to mediate the treatment effect A minimum of 5 individualized sessions with group sessions increased the treatmenteffect. Ethnic concordance increased the treatment effect.
The Well Elderly Intervention ModelLifestyle Redesign
Lifestyle Redesign enablespatients to design, practice,and ultimately enact apersonalized, sustainablehealth-promoting dailyroutine that is tailored toaddress CD risk factors aswell as promote health andwell-being more generally.
Intervention Modules1.2.3.4.5.6.7.8.9.10.11.12.Occupation, Health, and AgingCommunity Mobility, Transportation, and OccupationThe Building Blocks of Longevity: Various Types of ActivityStress and Inflammation ManagementDining and NutritionTime and OccupationHome and Community SafetyRelationships and OccupationThrivingNavigating HealthcareHormones, Aging, & SexualityEnding a Group – Finalizing Personal Engagement Plans(PEPs)
Lifestyle Redesign Becoming hyper-cognizant of activitypatternsNotice and name activitiesLearn the relationship of activities to health& well-being Activity Pattern AnalysisSelf-reflectIdentify barriersIdentify options and alternatives Lifestyle Redesign Select personalized healthy activity optionsMake changes in daily routinesPractice habits and routines Personalized Health Plan Engagement (PEP)
InterventionComparison
Structure of the Lifestyle Redesign Intervention Two-hour group sessions held eachweek for 9 months (Well Elderly I) or 6months (Well Elderly II) Led by an occupational therapist Group ventured into the communityonce every four weeks Up to 10 hours of individual sessionsoffered to each participant
Personal Engagement Plan (PEP)The PEP should be:My AttitudesOther KeyInformationMy BehaviorsThe PEP includes:My LifeMy Health Status Introduced early as part ofthe group session Reviewed regularly atindividual sessionsMy Needs Personal inventory ofstrengths and weaknesses Inventory of relevantpersonal factors Goals worksheet Daily health-promotingroutine planner
Formulating and Implementing the PEPAcquiring knowledge of factors related tooccupation that promote health and happinessPerforming a personal inventory and reflectingon one’s fears and occupational choices,interests, life goals, etc.Overcoming one’s fears by taking incrementalrisks in the real world of activity in small stepsover timeWeaving together the outcomes of the priorsteps to develop and sustain a healthpromoting daily routine
Mechanisms of ChangeKnowledge AcquisitionInternalizationHabit Formation
The USC Well Elderly Studies led to LecturesManualsTranslation in six European nationsUK National Institute for Health andClinical Excellence public health guidelinesIndependent analysesThis Lifestyle Redesign intervention approach is now beginning to be incorporatedinto public health policy and widely disseminated internationally
GroupSessionsIndividualSessions9 its
OUR VISION: Lifestyle Redesign in primary care
The need for comprehensivelife management programsin primary care Symptom management vs. prevention Keeping body systems in good healththroughout life Changing activity patterns early Increasing the overall conditioning of thebody Reducing inflammation before disease onset
Adopting a healthy lifestylelater in life Only 8.5% of middle-aged adults practice healthylifestylesHealthy dietRegular exerciseMaintaining a healthy weightNot smoking Only 8.4% newly adopt such a lifestyle past age 45 After only 4 years, adopting a healthy lifestyle inmiddle age can:Reduce mortality risk by 40%Reduce cardiovascular disease risk by 35%King, D. E., Mainous, A. G., & Geesey, M. E. (2007). Turning back the clock: adopting a healthy lifestyle in middle age. The American journal of medicine, 120(7), 598-603.
IT’S NEVER TOO LATE TOSTART LIVING A HEALTHIER LIFE
Lifestyle Redesign Intervention Lifestyle Redesign enables patients to design, practice, and ultimately enact a personalized, sustainable health-promoting daily routine that is tailored to address CD risk factors as well as promote health and well-being more generally Lifestyle f
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