A Randomized Study of the Efficacy of a New Intervention for Medication Adherence in Chronic Illness: Medications, Meaning and Me (The 3-M Study)

Purpose of the study - The purpose of this study is to develop and evaluate the efficacy of a new, theoretically based intervention to improve medication adherence in persons with HF. The hypotheses include: Hypothesis I. Poorly adherent patients with symptomatic HF who receive the intervention (n=40) will be more adherent to medicines during the12-month intervention than a control group (n=40) of poorly adherent patients with symptomatic HF. Hypothesis II. Poorly adherent patients with symptomatic HF who receive the intervention (n=40) will have fewer hospital readmissions (HR) and emergency department (ED) visits during the 12-month intervention than a control group of poorly adherent patients with symptomatic HF. Study Activities and population - A prospective, randomized controlled design will be used to pilot test the efficacy of a new intervention to promote adherence to the medication regimen in chronic heart failure in the clinical setting. The initial development and feasibility testing of the intervention is complete (Preliminary Work, Section 4.5). Patients with HF symptom exacerbation (n = 80) who exhibit high likelihood of poor adherence, as determined by a validated screening measure, the Medication Adherence Scale (MAS)89 at baseline assessment, will be recruited and randomized to receive the intervention or usual care with attention control. Medication adherence, symptom frequency and intensity, hospital readmissions (HR) and emergency department (ED) visits will be assessed in both groups at 3, 6 and 12-month clinic visits. The intervals between visits are considered sufficient to minimize sensitization bias to psychometric measures. Longitudinal measurement is required to evaluate the magnitude of change in adherence and symptom-related events occurring over time. Efficacy will be measured as improved adherence (primary outcome) and decreased HR and ED visits (secondary outcomes) in the intervention group as compared to the attention control gr