The devil is in the detail - a multifactorial intervention to reduce blood pressure in co-existing diabetes and chronic kidney disease: a single blind, randomized controlled trial

BMC Family Practice

Study Protocol

Rowan G Walker¹  Elizabeth Manias²  Allison F Williams² 

[1] Department of Medicine, The University of Melbourne, 3053, Carlton, Australia;Nephrology Department, Royal Melbourne Hospital, Parkville, Australia;Melbourne School of Health Sciences, The University of Melbourne, Level 5, 234 Queensberry Street, 3053, Carlton, Australia;

关键词: Chronic Kidney Disease;    Medication Adherence;    Gliclazide;    Usual Care Group;    Pill Count;   

DOI  :  10.1186/1471-2296-11-3

 received in 2009-08-19, accepted in 2010-01-12,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundAbout 30-60% of individuals are non-adherent to their prescribed medications and this risk increases as the number of prescribed medications increases. This paper outlines the development of a consumer-centred Medicine Self-Management Intervention (MESMI), designed to improve blood pressure control and medication adherence in consumers with diabetes and chronic kidney disease recruited from specialist outpatients' clinics.MethodsWe developed a multifactorial intervention consisting of Self Blood Pressure Monitoring (SBPM), medication review, a twenty-minute interactive Digital Versatile Disc (DVD), and follow-up support telephone calls to help consumers improve their blood pressure control and take their medications as prescribed. The intervention is novel in that it has been developed from analysis of consumer and health professional views, and includes consumer video exemplars in the DVD. The primary outcome measure was a drop of 3-6 mmHg systolic blood pressure at three months after completion of the intervention. Secondary outcome measures included: assessment of medication adherence, medication self-efficacy and general wellbeing. Consumers' adherence to their prescribed medications was measured by manual pill count, self-report of medication adherence, and surrogate biochemical markers of disease control.DiscussionThe management of complex health problems is an increasing component of health care practice, and requires interventions that improve patient outcomes. We describe the preparatory work and baseline data of a single blind, randomized controlled trial involving consumers requiring cross-specialty care with a follow-up period extending to 12 months post-baseline.Trial RegistrationThe trial was registered with the Australian and New Zealand Clinical Trials Register (ACTRN12607000044426).

【 授权许可】

CC BY   
© Williams et al; licensee BioMed Central Ltd. 2010