Tertiary Prevention in Type II Diabetes Mellitus in Canary Islands Study

Effectiveness and Cost-effectiveness of Two Multi-component Interventions to Improve the Health Outcomes in People With Type 2 Diabetes Mellitus

Objective:

• To improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by influencing disease self-management through lifestyle modification and by helping primary care professionals to improve health care provided to patients.
• To assess the effectiveness and cost-effectiveness of two complex interventions (education and behavioural modification, independently and conjointly, for primary health care teams (PHCT) and patients and their relatives) to improve the health results in people with T2DM.

Methodology:

Design: Randomized clinical trial. Setting: Basic healthcare district in Canary Islands. Spain. Subjects: Patients with T2DM, 18-65 years old, without complications. Main measures: HbA1c, rate of patients with properly controlled T2DM. Sample: 2328 patients, 582 per arm. Intervention: G1: Interventions on the patients: Educational and habit modification group program. G2: Intervention on the PHCT: a) Educative intervention to improve the knowledge about the disease and their abilities; b) Computer-based clinical decision support system; c) Feedback of results. G3: Interventions on the patients and the PHCT. G4: Control group. Patients receive only the usual care.

Inclusion Criteria:

Patients:

• T2DM diagnosis
• aged between 18 and 65

Health professionals:

• primary health care teams (PHCT) comprising a primary care physician and a nurse practitioner associated to a patient will be selected
• must have a permanent position or a stable substitute position

Exclusion Criteria:

• peripheral vascular disease
• diabetic nephropathy and/or chronic kidney disease
• cognitive impairment, dementia
• major depression
• insufficient level of Spanish
• to be pregnant or planning to become pregnant in the next 6 months
• cancer last 5 years
• ischemic disease or heart failure
• proliferative diabetic retinopathy