Tertiary Prevention in Type II Diabetes Mellitus in Canary Islands Study
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Behavioral: Intervention to patientsBehavioral: Intervention to professionalsOther: Usual care
- Registration Number
- NCT01657227
- Lead Sponsor
- Servicio Canario de Salud
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2334
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention to Patients Intervention to patients Only patients receive intervention Mixed Intervention Intervention to patients Patients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive intervention Intervention to Patients Usual care Only patients receive intervention Control Usual care Patients receive usual care Intervention to healthcare Professionals Intervention to professionals Primary care physicians and nurses practitioners receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals Intervention to healthcare Professionals Usual care Primary care physicians and nurses practitioners receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals Mixed Intervention Intervention to professionals Patients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive intervention Mixed Intervention Usual care Patients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive intervention
- Primary Outcome Measures
Name Time Method Change in Glycosylated hemoglobin (HbA1c) Baseline and 12 months Change in Glycosylated hemoglobin from baseline to 12 months
- Secondary Outcome Measures
Name Time Method Change in HDL level Baseline and 6, 12 and 24 months Change in LDL level Baseline and 6, 12 and 24 months Change in Total cholesterol level Baseline and 6, 12 and 24 months Medication administration Baseline and 6, 12, 18 and 24 months Initiation of new drugs or dosage adjustment: insulin, antidiabetics, hypolipidemics, antihypertensives, etc.
Change in Weight Baseline and 3, 6, 12, 18 and 24 months Change in ADDQoL score Baseline and 6, 12, 18 and 24 months ADDQoL is a specific questionnaire for health related quality of life (HRQL) assessment
Change in tabacco consumption Baseline and 3, 6, 12, 18 and 24 months Acceptability of interventions and satisfaction (INDICA-SATP) 24 months Change in Diabetes Knowledge Baseline, 12 and 24 months Change in Glycosylated hemoglobin (HbA1c) Baseline and 3, 6, 18 and 24 months Change in Waist circumference Baseline and 3, 6, 12, 18 and 24 months Change in Body Mass Index (BMI) Baseline and 3, 6,12, 18 and 24m Change in International Physical Activity Questionnarie (IPAQ) score Baseline and 6, 12, 18 and 24 months Change in Diabetes Empowerment Scale - Short Form (DES-SF) score Baseline, 12 and 24 months Change in Basal glucose Baseline and 3, 6, 12, 18 and 24 months Change in EQ-5D index Baseline and 6, 12, 18 and 24 months EQ-5D is a generic questionnaire for health related quality of life (HRQL) assessment
Change in Mediterranean Diet Adherence Screener (MEDAS) score Baseline and 6, 12, 18 and 24 months Change in Stait-Trait Anxiety Inventory (STAI) score Baseline, 12 and 24 months Change in Beck Depression Inventory - II (BDI-II) score Baseline, 12 and 24 months Change in Diabetes Distress Scale (DDS2) score Baseline, 12 and 24 months Change in Morisky Compliance Scale Baseline and 6, 12, 18 and 24 months Change in Triglycerides Baseline and 6, 12 and 24 months
Trial Locations
- Locations (1)
Servicio de Evaluación del Servicio Canario de la Salud
🇪🇸Santa Cruz de Tenerife, Spain