1. CAN ADHERENCE BE IMPROVED?

2. Status of Adherence Intervention Studies • To Medication • To Exercise • To Diet

3. 19 Adherence Intervention Studies • Randomized • Control Group • Assessment of Adherence • Assessment of Outcome • 6 month Follow Up Haynes, R. B., Montague, P., Oliver, T., McKibbon, K. A., Brouwers, M. C., & Kanani, R. (2001). Interventions for helping patients to follow prescriptions for medications. [Systematic Review] Cochrane Consumers & Communication Group Cochrane Database of Systematic Reviews.

4. 19 Adherence Intervention Studies  All Use Self - Report  1 Study addresses Remediation • Education/Counseling/Behavioral Strategies • All Address Single Regimen/Disease

5. Characteristics of Successful Interventions • Educational/Behavioral • Multicomponent • Long-Term (from Haynes, 1996)

6. Adherence Monitoring as Intervention • Use of Electronically Monitored Data as Feedback • Improved Blood Pressure Control1 Improved Blood Pressure Management • Reduction in Seizures2 Improved Adherence 1 Bertholet et al, 2000 2 Schneider et al, 2000

7. Summary of Interventions • Education • Social Support • Self-Efficacy Enhancement • Behavioral Intervention • Electronic Monitoring/Feedback • Self-Monitoring • Counseling • Positive Reinforcement • Cuing • Verbal Persuasion

8. Interventions to Promote Adherence to Exercise • Self-Monitoring 1,6,8 • Counseling 2,6,7 • Positive Reinforcement 1,5 1 Atkins et al, 1984 2 Belise et al, 1987 3 Daltroy, 1985 4 Jakicic et al, 1995 5 Keefe & Blumenthal, 1980 • Cuing 1,5 • Verbal Persuasion 3 • Education 4,9 6 King et al, 1988 7 King & Frederikson, 1984 8 Rogers et al, 1987 9 Schneiders et al, 1998

9. Interventions to Promote Adherence to Dietary Regimen • Counseling 3,4,8 • Social Support 1,2,6 • Self-Efficacy Enhancement6 1 Barnard et al, 1992 2 Borbjerb et al, 1995 3 Dolecek et al, 1986 4 Glueck et al, 1986 5 Karvetti, 1981 • Education 5,7 • Behavioral Intervention 9 6 McCann et al, 1988 7 Mojonnier et al, 1980 8 Simkin-Silverman et al, 1995 9 Wing & Anglen, 1996

10. Summary • Interventions are not targeted to patient adherence patterns or to patient-reported reasons for poor adherence • Outcome measures are not reliable or accurate • Very few RCT’s have been reported

11. 3 Randomized Controlled StudiesDesigned to Examine Strategies to Improve Compliance Study 1. An intervention study designed to improve poor adherers - asymptomatic condition Study 2. An intervention study with poor compliers - symptomatic condition Study 3. Adherence in clinical trials - an induction study

12. An Intervention Study Designed to Improve Poor Compliers Purpose: To evaluate a multicomponent behavioral strategy designed to improve compliance among poor compliers Setting: Multi-center randomized controlled clinical trial designed to test the cholesterol hypothesis * Coronary Primary Prevention Trial

13. Proportion of Subjects> 75% Compliance Pre-intervention Post-Intervention* Experimental 0 9 Attention Control 0 1 Usual Care 0 3 * 2 = 10.21, 2dƒ, p = .006

14. Change in Cholesterol Levels

15. Variability in Adherence and Treatment Response • Greater response to monitoring/attention • overestimated compliance (r = .75) • greater variability (r = .50) • Relationship between variability and overestimation (r = .54)

16. An Intervention Study Designed to Improve Poor AdherersRAC-1 Purpose: To evaluate a series of behavioral/problem solving interventions to improve poor adherence Setting: Specialty practice sites

17. RESULTS Group Differences Baseline To End Of Treatment • Average Change In Adherencex sd Intervention 4.30 + 24.7 Usual Care -7.99 + 27.1 t = -2.02, p = .023 • Proportion Greater Than 80% Adherence Intervention + Maintenance = 29.7% Usual Care = 15.6% X2 = 2.25, df = 1, p = .065

18. Relationship of Change in Adherence and Functional Status Tx F/U Adherence: Pain rs = .02 rs = -.22* (n = 96) (n = 98) Adherence: Difficulty rs = .04 rs = -.11 (n = 95) (n = 97) Adherence: Assistance rs = .03 rs = -.12 (n = 96) (n = 97) *p<.01Changes in adherence were associated with changes in pain in carrying out activities of daily living, but no level of difficulty or assistance required

19. Predictors of Change • Baseline Correlates With Change Score End of Treatment rs = -.20 p = .036 Follow-up rs = -.32 p = .001 • Session Attendance and Change Score Follow-up f = 9.07, df = 2, p = .0007

20. Compliance in Clinical Trials - An Induction Study • Purpose: To evaluate a minimal strategy designed to promote initial compliance • Setting: Single center randomized, clinical trial designed to study the psychological and behavioral effects of cholesterol lowering* * M. Muldoon, the CARE Study

21. Group Differences in AdherenceACTat 6 Months n = 180 MEMS MEMS Pill Count (% days compliant)(% pills taken) Usual Care (Mdn) 62.5% 85.7% 93.5% Habit Training (Mdn) 67.9% 92.8% 96.1% Habit Training (Mdn) 61.6% 90.2% 93.8% + Problem Solving p = NS NS NS

22. Summary • Poor Adherence is: • Wide Spread • Costly • Hard to Identify • Difficult to Predict Who Does Not Adhere • Few Studies Point to Interventions

23. Summary • Individuals vary in dosing adherence • Measures to identify poor adherence need to be sensitive to dosing patterns • Minimal intervention does not appear to improve long-term adherence • Adherence can be improved with intensive interventions • Improving adherence positively impacts clinical outcomes

24. Recommendations • Address individual adherence patterns in clinical and research setting • Take careful account of method of assessment in interpretation of adherence data • Design/evaluate adherence interventions

25. Any Questions? Thank You!