Translating Observational and Labbased Trials to Community-based Interventions: Why and How

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Wendy Sims
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Aging and Health Workshop on Understanding Pathways to Successful Aging: Behavioral and Social Factors

1 Translating Observational and Labbased Trials to Community-based Interventions: Why and How Michelle C. Carlson, PhD Johns Hopkins Bloomberg School of Public Health Department of Mental Health, Center on Aging and Health Workshop on Understanding Pathways to Successful Aging: Behavioral and Social Factors Related to Alzheimer s Disease National Academy of Sciences, Engineering and Medicine June 12-13,

2 Overview Why do community interventions? Any movement is good (Revenge of the Sit I & II) Building Metrics Around Movement- incorporating wearable devices to develop indices that inform evaluation, mechanism and intervention design Why do people move? Social, purposeful and other motivations to tap into Why don t people move? Barriers related to the individual s health and to the environment Environment as key intervention design factor- includes safety, available infrastructure, community partners Challenges & Opportunities- engaging & building trust with stake holders, sustaining & growing a community-based intervention post study

Why Do Interventions in the Translating Beneficial Behaviors into Everyday Life styles=> Behavior change Physical activity/exercise Cognitive activity

3 Why Do Interventions in the Translating Beneficial Behaviors into Everyday Life styles=> Behavior change Physical activity/exercise Cognitive activity Retain/regain social purpose Reaching at risk populations in their communities Scaling up from clinic/lab to generalize to real-world environments Community?

Lifestyle Physical Activity and Brain Health 1000 more

brain region important to memory and dementia risk

values Lhippocampus Varma, Chuang, Harris, Tan, &

4 Lifestyle Physical Activity and Brain Health 1000 more steps/ day is associated with a larger hippocampus, a brain region important to memory and dementia risk Even small increases in daily walking activity may matter avg_steps Fitted values Lhippocampus Varma, Chuang, Harris, Tan, & Carlson, 2014, Hippocampus PA associated with subiculum in women Varma, Tang, & Carlson, 2015 Hippocampus

adults; particularly those of low socioeconomic status (SES) Benefits of low-intensity physical activity in enriched, daily

5 Physical Activity (PA) Guidelines for Older Adults: Determined by Environment Current Guidelines: 30 minutes/day of moderate-intensity PA ; 20 minutes/day of vigorous-intensity PA three days/week Difficulties in reaching PA targets for older adults; particularly those of low socioeconomic status (SES) Benefits of low-intensity physical activity in enriched, daily environments? Sources: HHS: Health People 2020; Tudor-Locke & Basset, 2004; PAG Report, 2008; Marshall, et al. 2007; Parra- Medina, 2010

executive function, memory Reading literacy Library support Math support Behavioral support >15 hours per wk Travel to & from

6 Linking Physical Activity to Social Engagement with a Purpose: Volunteering -Desire to remain generative & productive -Harnessing one s lifetime of accumulated wisdom Volunteers 60 and older Serve in public elementary schools: K-3 Multiple roles to exercise executive function, memory Reading literacy Library support Math support Behavioral support >15 hours per wk Travel to & from schools; walking within schools Sustained dose: full school year Freedman & Fried, 1997; Fried et al., 2004; Fried et al., 2013; Glass et al., 2004

Baltimore Experience Corps Trial Evaluation funded by NIA BSR: 2006-2013 Randomized: 702 60 yrs.

Exposure: 2 years of high-intensity service Outcomes: Physical: Disability, mobility, walking

7 Baltimore Experience Corps Trial Evaluation funded by NIA BSR: Randomized: yrs. and older to EC or low-activity control Matched 25 public elementary schools with EC to control Exposure: 2 years of high-intensity service Outcomes: Physical: Disability, mobility, walking speed Cognitive: Memory, executive function Psychosocial well-being Nested Brain Health Substudy(N=120)

8 Intervention Recruitment Message & Mechanisms: Causal Pathway Primary Pathways Mechanisms Performance-based outcomes Falls Physical Activity Strength, balance Walking Speed Frailty MESSAGE: Generative Service Cognitive Activity Brain plasticity; Executive function Memory IADLs Social Activity, Engmnt. Social Integration & Support Generativity Psycho-Social Well-being

9 Did We Increase Daily Physical Activity Following Program Participation? Step Activity (N=115): Women in Experience Corps maintained average steps/day over 24 months post-intervention while Controls declined. Men had significantly higher baseline levels of daily physical activity than women and maintained these levels. Women EC= red; Control= blue Average steps/day Control 5000 Baseline 12-months 24-months Intervention Varma, Tan, Gross, Harris, Romani, Fried, Rebok, Carlson, 2015 AJPM

10 Does Experience Corps Lead to Changes in Brain Health? Men in the Experience Corps arm showed a % increase in total cortical and hippocampal brain volumes v. declines in controls. Women in Experience Corps also tended to exhibited modest gains of % by 24 months of exposure Men: Hippocampal Volume (mm 3 ) 2-year improvement in memory related to 2-year increase in whole brain volume in EC (blue Volume (mm 3 ) Baseline 12 month 24 month Intervention Control year change in Whole-Brain volume In C Carlson, Kuo, Chuang, Varma, et al., 2015 Alz & Dementia

Experience Corps also impacts the amygdala, a

, 2013) (see nice meta-review by Bruhl et al.

11 Experience Corps also impacts the amygdala, a region important to socially salient information and a biomarker for AD risk (Miller et al., 2013) (see nice meta-review by Bruhl et al., 2014) Using shape diffeomorphometry, we see specific patterns of change Control Intervention Only the left amygdala shows significant group differences post-intervention, after correction for multiplecomparisons (p=0.0052) Group Diff Carlson, Varma, Miller, & Tang, under review 11

12 From School to Community: Building Metrics to Identify Opportunities for Purposeful Activity in Daily Life Measure real-time contexts in daily life when it occurs by expanding use of real-time mobile assessment in the community Are there hot spots? Are there diurnal patterns when individuals are most able to exercise? Is meaningful vs. any social engagement a magic ingredient? Create opportunities, particularly in lowresourced neighborhoods

13 Using GPS+ accelerometers to determine where the greatest amounts of outdoor activity occur in daily life Carlson, Varma, Adam, Crainiceanu, & Zipunnikov, under review

14 Environmental Barriers to Physical and Social Activity Distribution of BECT participants across Baltimore City (n=535)

Jeopardy- At risk individual in at-risk environment Community

15 HotSpot analysis of participants with poor global cognition (MMSE scores <26) (left panel) and with poor memory (right panel) Double Jeopardy- At risk individual in at-risk environment Community interventions can target both Adam, Varma, Harris, & Carlson, under review

Place Matters Location where intervention takes place Is accessible, in members neighborhoods capitalizes on existing school & other community infrastructures Schools & senior centers offer safe

16 Place Matters Location where intervention takes place Is accessible, in members neighborhoods capitalizes on existing school & other community infrastructures Schools & senior centers offer safe access in & around (e.g., side walks) (Tan et al., 2010 Am J. Public Health) Examples of Community-based Interventions: Community Choirs (Johnson, UCSF; NIA ) conducted in partnership with San Francisco Community Music Center & SF Dept. of Aging & Adult Services SYNAPSE Project (Park et al., 2014) Senior Odyssey of the Mind (Stine-Morrow et al., 2008) Theatre acting (Noice & Noice, 2004, 2014)

17 Identifying & Engaging Stake Holders in Research-Community Partnerships Identify all stake holders needs: Older adults: cognition, physical function, disease management Children & young adults: literacy, obesity, bullying, substance abuse Identify community partners local gov t & non-profit agencies, senior centers, etc. Listen & share in intervention design = collaboration Build trust! Challenges & opportunities Sustainability beyond research enterprise Cost effectiveness

18 It Takes a Village: Research Team and Collaborators Jeremy Barron - JHU Michelle Carlson - JHU Yi-Fang Chuang - Natl Yang Ming U Kay Dickersin - JHU Kirk Erickson - U Pittsburgh Constantine Frangakis - JHU Linda Fried - Columbia U Kevin Frick JHU Alden Gross - JHU Tara Gruenewald USC Jin Huang - JHU Arthur Kramer - Northeastern U Sylvia McGill - EC Baltimore Jeanine Parisi - JHU Christine Ramsey VA CT George Rebok - JHU William Romani AARP David Roth - JHU Roberta Scherer - JHU Teresa Seeman - UCLA Erwin Tan AARP Elizabeth Tanner JHU Vijay Varma NIA, LBN Keith Whitfield Wayne State U Paul Willging - JHU Qian-Li Xue - JHU

19 Funding Acknowledgments Experience Corps Trial Alzheimer s Drug Discovery Foundation NIA BSR Grant # P01AG supplement Greater Homewood Community Corporation Johns Hopkins OAIC Pepper Center Grant #P30AG Johns Hopkins Neurobehavioral Research Unit S.D. Bechtel Award Geo-Coded Activity Johns Hopkins ADRC Pilot Grant Johns Hopkins OAIC Pepper Center Grant #P30AG021334

20 Trial Methods: Analysis of Older Adults CACE Complier Non-Complier ITT Intervention N1 N2 Control N3 N4 Intention-to-treat (ITT): Intervention vs. Control ignoring compliance (i.e., N1+N2 vs. N3+N4) Complier average causal effect (CACE): Intervention vs. Control among compliers (i.e., N1 vs. N3)

21 Some Terms Active Control: Control condition is the principal method of removing the influence of unwanted variables to determine the effectiveness of the Intervention condition in a randomized, controlled trial (RCT) Community-based Intervention: interventions embedded within community settings and infrastructures Equipoise: Ethical considerations, including assurances of receiving the best available standard therapy (clinical) and non-maleficence Generalizability: as applied to outcomes, the impact of an intervention on outcomes beyond those abilities and systems trained or exercised. May also be described as near and far transfer. Prevention: interventions designed to delay and reduce the risk of onset of clinical disease(s) Randomized Controlled Trial: provides critical evidence for the efficacy or effectiveness of behavioral interventions Risk/Protection Factor: behavioral, health, demographic, and/or environmental factors that may increase/reduce one s risk for an adverse health outcome Sustainability: program maintenance independent of research funding, often done in collaboration with community stakeholders

Presentation Objectives

Presentation Objectives Best Practices for Maintaining Cognitive Health in Older Age George W. Rebok, Ph.D., MA Professor, Department of Mental Health Johns Hopkins Bloomberg School of Public Health Elizabeth K. Tanner, Ph.D.,