A multifactorial intervention to improve blood pressure control in co-existing diabetes and kidney disease: a feasibility randomized controlled trial.

AIMS

The aim of this study was to test the feasibility and impact of an intervention consisting of self-monitored blood pressure, medicine review, a Digital Versatile Disc, and motivational interviewing telephone calls to help people with diabetes and kidney disease improve their blood pressure control and adherence to prescribed medications.

BACKGROUND

People with co-existing diabetes, kidney disease and hypertension require multiple medications to manage their health. About 50% of people are non-adherent to their prescribed medications with non-adherence increasing in the presence of chronic conditions.

DESIGN

Randomized controlled trial.

METHODS

Patients aged ≥18 years with diabetes, chronic kidney disease and systolic hypertension were recruited from nephrology and diabetes outpatients' clinics of an Australian metropolitan hospital between 2008-2009. Participants were randomly allocated on a 1:1 basis to one of two groups in a randomized controlled trial: the intervention delivered over 3 months (n = 39) and usual care (n = 41), with follow-up at 3, 6 and 9 months postintervention. People collecting data and assessing outcomes were blinded to group assignment.

RESULTS

Seventy-five participants completed the study. The intervention was acceptable and feasible for this cohort. There were no statistically significant differences between groups, although the mean systolic blood pressure reduction in the intervention group (n = 36) was -6·9 mmHg 95% CI (-13·8, -0·02) at 9 months postintervention.

CONCLUSION

The study was feasible and statistically significant differences may be determinable in a larger sample to overcome the variability between groups, paying attention to recommendations for further research.

TRIAL REGISTRATION

The trial was prospectively registered with the Australian and New Zealand Clinical Trials Register (ACTRN12607000044426).