MONTREAL (FRONTLINE MEDICAL NEWS) – A real-world study that compared the efficacy of two add-on, self-care enablement programs with that of usual care for patients with uncomplicated type 2 diabetes mellitus (T2DM) found that participants in each self-care program had a significantly reduced relative risk of cardiovascular disease (hazard ratios, 0.84 and 0.86; P less than .001).

The programs also reduced the risk of 3-year, all-cause mortality, said Cindy Lam, MD, presenting the results of the observational cohort study at the annual meeting of the North American Primary Care Research Group.

Dr. Lam, head of the department of family medicine and primary care at the University of Hong Kong, said that patients who received public primary care in Hong Kong and had suboptimal control of type 2 diabetes were assigned to usual care or usual care plus one of two additional interventions aimed at improving diabetes self-care. Of the 63,846 patients, 47,802 received usual care, while in addition to usual care, 10,030 received in-person small group counseling and 6,014 got telephone calls from nurses.

The patient empowerment program (PEP) was a series of four 2-hour sessions conducted with small groups of 10 to 20 patients over the course of 3-4 months.

Two of the PEP sessions were disease-specific, and two were more generic. The diabetes-specific sessions aimed to give participants relevant knowledge and skills, first exploring the treatment goals and potential complications of diabetes, then offering a self-monitoring component that taught “contingency management,” such as how to handle sick days or wide blood glucose excursions. The sessions covered disease-specific lifestyle modification and information about weight management as well.

The generic sessions aimed to bolster self-efficacy and empower patients to make changes. More lifestyle modification information was provided, and patients were given tools to help with goal-setting and implementation of concrete plans. The sessions also offered stress-management techniques and gave tips for effective communication with healthcare professionals.

Patients who received telephone calls from the patient support call center (PSCC) heard from trained nurses on a weekly to twice-weekly basis for 3 months and then on an as-needed basis for an additional 9 months.

The PSCC calls also were designed to reinforce self-care behavior by focusing on self-monitoring, managing risk factors and medications, improving diet and exercise, and sharpening coping and problem-solving skills. At each call, the nurse would engage in shared decision making with the patient to set targets related to diabetes management goals and realistic timetables and priorities. The jointly developed care plan was supported by additional services if indicated.

Slightly fewer than half of the patients in each group were male; the mean age was about 64 years. Patients with end-stage renal disease or cardiovascular disease (CVD) were excluded, as were those who were receiving specialist care.

Patients were not randomly assigned but rather were assigned according to the care management prescribed by primary care physicians, so there were some differences among groups, said Dr. Lam. Notably, patients assigned to the PSCC intervention had a significantly higher average hemoglobin A1c level (8.51%, compared with 7.18%-7.25% in the other two groups; P less than .001). They were also more likely to be insulin users (7.5% versus 2.02%-2.20%; P less than .001). These and other differences were accounted for in the multivariable analysis, said Dr. Lam.

Dr. Lam and her colleagues looked at the incidence of CVD – the primary outcome – as well as end-stage renal disease and death, the secondary outcomes. They also tracked hemoglobin A1c levels, blood pressure, and lipid values, as well as use of insulin, oral diabetes medication, and antihypertensive and lipid medications.

Having followed patients for a median 3 years, the investigators used multivariable analysis to ascertain the effect of participation in each group on the primary and secondary outcomes, adjusting for differences in baseline characteristics.

The cumulative incidence of CVD in the usual care group was 5.3%, compared with 4.0% for the PEP group and 4.8% for the PSCC group. After adjustment, this represented a relative risk reduction of 14% for the PEP group and 16% for the PSCC group, compared with usual care.

The incidence of all-cause mortality was 3.2% in the usual care group, 1.8% in the PEP group, and 2.7% in the PSCC group. Here, PEP participation was associated with a significantly reduced relative risk of mortality when compared with the PSCC group in the adjusted analysis (33%; hazard ratio, 0.67; P less than .001).

Although the study had some limitations centering on its retrospective, observational design, Dr. Lam emphasized that “this is truly a real-world study,” showing that interventions that target self-care enablement in a personalized way reduced both all-cause mortality and CVD in a large population. However, said Dr. Lam, “Generalization to private practice and to non-Chinese populations is uncertain.”

Dr. Lam reported no conflicts of interest.

SOURCE: Lam C et al. NAPCRG 2017, Abstract DB14 .