title: Translating basic behavioral and social science research to clinical application: the EVOLVE mixed methods approach.
abstract: OBJECTIVE
  To describe a mixed-methods approach to develop and test a basic behavioral science-informed intervention to motivate behavior change in 3 high-risk clinical populations. Our theoretically derived intervention comprised a combination of positive affect and self-affirmation (PA/SA), which we applied to 3 clinical chronic disease populations.
  
  
  METHODS
  We employed a sequential mixed methods model (EVOLVE) to design and test the PA/SA intervention in order to increase physical activity in people with coronary artery disease (post-percutaneous coronary intervention [PCI]) or asthma (ASM) and to improve medication adherence in African Americans with hypertension (HTN). In an initial qualitative phase, we explored participant values and beliefs. We next pilot tested and refined the intervention and then conducted 3 randomized controlled trials with parallel study design. Participants were randomized to combined PA/SA versus an informational control and were followed bimonthly for 12 months, assessing for health behaviors and interval medical events.
  
  
  RESULTS
  Over 4.5 years, we enrolled 1,056 participants. Changes were sequentially made to the intervention during the qualitative and pilot phases. The 3 randomized controlled trials enrolled 242 participants who had undergone PCI, 258 with ASM, and 256 with HTN (n = 756). Overall, 45.1% of PA/SA participants versus 33.6% of informational control participants achieved successful behavior change (p = .001). In multivariate analysis, PA/SA intervention remained a significant predictor of achieving behavior change (p < .002, odds ratio = 1.66), 95% CI [1.22, 2.27], controlling for baseline negative affect, comorbidity, gender, race/ethnicity, medical events, smoking, and age.
  
  
  CONCLUSIONS
  The EVOLVE method is a means by which basic behavioral science research can be translated into efficacious interventions for chronic disease populations.
authors.affiliation: Division of Clinical Epidemiology and Evaluative Sciences Research, Department of Medicine, Weill Cornell Medical College.
authors.forename: Janey C
authors.initials: JC
authors.lastname: Peterson
authors.forename: Susan
authors.initials: S
authors.lastname: Czajkowski
authors.forename: Mary E
authors.initials: ME
authors.lastname: Charlson
authors.forename: Alissa R
authors.initials: AR
authors.lastname: Link
authors.forename: Martin T
authors.initials: MT
authors.lastname: Wells
authors.forename: Alice M
authors.initials: AM
authors.lastname: Isen
authors.forename: Carol A
authors.initials: CA
authors.lastname: Mancuso
authors.forename: John P
authors.initials: JP
authors.lastname: Allegrante
authors.forename: Carla
authors.initials: C
authors.lastname: Boutin-Foster
authors.forename: Gbenga
authors.initials: G
authors.lastname: Ogedegbe
authors.forename: Jared B
authors.initials: JB
authors.lastname: Jobe
mesh_terms: D000328:Adult; D001741:Black or African American / Q000523:psychology; D000368:Aged; D001249:Asthma / Q000523:psychology / Q000534:rehabilitation; D001524:Behavioral Medicine / Q000379:methods* / Q000592:standards; D003324:Coronary Artery Disease / Q000523:psychology / Q000534:rehabilitation; D005260:Female; D015438:Health Behavior / Q000208:ethnology*; D006801:Humans; D006973:Hypertension / Q000523:psychology / Q000534:rehabilitation; D008297:Male; D008875:Middle Aged; D008960:Models, Psychological; D010349:Patient Compliance / Q000523:psychology; D010865:Pilot Projects; D057170:Translational Research, Biomedical / Q000379:methods*; D016896:Treatment Outcome