The aim of this study was to examine whether motivating patients to gain expertise and closely follow their risk parameters will attenuate the course of microvascular and cardiovascular sequelae of diabetes. A randomized, prospective study was conducted of 165 patients who had type 2 diabetes, hypertension, and hyperlipidemia and were referred for consultation to a diabetes clinic in an academic hospital. Patients were randomly allocated to standard consultation (SC) or to a patient participation (PP) program. Both groups were followed by their primary care physicians. The mean follow-up was 7.7 yr. The SC group attended eight annual consultations. The PP patients initiated on average one additional consultation per year. There E ducational and behavioral interventions hitherto published in patients with diabetes had only modest effects on alleviation of disease progression (1). The poor outcomes may be partially due to deficiencies in diabetes knowledge, compliance, and motivation (2,3). Intensive therapeutic programs are effective in reducing diabetic complications and cardiovascular morbidity and mortality (4 -9). These programs, however, all have been randomized, prospective trials conducted by experts in academic medical centers. The extrapolation of the achievements of these programs to primary care is difficult because of both financial and organizational shortcomings. We showed previously that sharing the therapeutic responsibility with the patients themselves had a major impact on retarding the progress of microvascular complications (10). Reported herein is the second, 4-yr, phase of the study highlighting the influence of the intervention on cardiovascular outcomes.
Materials and MethodsA total of 167 patients who had type 2 diabetes, hypertension, and dyslipidemia and referred for consultation to the diabetes clinic of Meir Hospital during the years 1995 to 1996 were randomized to a standard consultation (SC) or to a patient-participation program (PP). The inclusion criteria were age 40 to 70 yr; type 2 diabetes of Ͻ10 yr duration; BMI Յ35 kg/m 2 ; BP values Ն140/90 mmHg; LDL Ն120 mg/dl; serum creatinine Յ2 mg/dl (176 mol/L); albumin/creatinine ratio Ͻ200 mg/g; and no history of myocardial infarction, angina pectoris, vascular surgery, stroke, or any systemic or malignant disease. A total of 154 patients signed informed consent forms, 13 patients were excluded, and 141 were randomized by the help of computergenerated random numbers to either SC (n ϭ 70) or PP (n ϭ 71) programs. The flow of the patients throughout the study is outlined in Figure 1.Patients of both groups were initially interviewed and examined twice over 2 wk and annually thereafter. Consultation letters were written to the family physicians. No prescriptions were ever issued by members of the consultation team. The patients of the SC group attended standard consultation visits, whereas the patients of the PP program were given two 2-h teaching sessions about ways to achieve tight control of the modifiable risk factors including also ...