The aim of the study is to evaluate the utility of behavior theory-directed computer-based telecommunications technology to improve medication regimen adherence in adult patients with chronic disease. To this end, we will enhance an existing telecommunications system Telephone-Linked Care for Medication Adherence (TLC-MED) that applies constructs from Social Cognitive Theory (SCT) to monitor, educate and counsel adults with chronic disease through weekly automated telephone conversations. The system also sends periodic reports to their physicians to assist in patient care. In the proposed study, we will enhance the existing version of TLC-MED, which was shown to be effective in a randomized clinical trial of patients with hypertension, in the following manner. We will more fully apply four SCT constructs (self-efficacy, outcome expectations, behavioral capability, and reinforcement) in the TLC-MED conversations and use electronic medication monitoring which is more accurate than patient self-report. We wll combine this enhanced version of TLC-MED with TLC chronic disease monitoring modules for four common chronic diseases (hypertension, coronary heart disease, chronic obstructive lung disease, and diabetes mellitus) to create an integrated TLC-MED chronic disease system. Because of the increasing prevalence and importance of delivering health care services to patients who have more than one chronic disease, we will study TLC-MED in patients who have at least two of these four common chronic diseases. Because of societal needs to provide health care services to disadvantaged populations, we will study TLC-MED in two clinical settings with large numbers of disadvantaged patients, both African-American and Caucasian. TLC-MED will be evaluated in a two-arm randomized clinical trial of 440 adult, primary care patients. All subjects will have an educational session to promote medication regimen adherence. In addition, TLC-MED subjects will use the system weekly for 6 months. All subjects will be evaluated for outcomes at baseline, 6 months, and 15 months (9 months post-intervention). The principal outcomes will be (1) overall medication regimen adherence, (2) medication regimen adherence for each of the four targeted diseases and a non-targeted chronic disease, (3) intervening behavioral variables (the four SCT constructs), and (4) distal clinical variables (general and disease-specific). We will also explore how disease co-morbidity affects medication adherence and the TLC-MED intervention effects.
