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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,334
Multifaceted intervention consisting of: * Program of education and behavior modification: group sessions conducted by health educators for the patient and a relative (who usually do the food shopping or prepare meals) every 3 months over 2 years (total:8 sessions). Main contents: diabetes, hygiene/nutrition and physical exercise. * Monitoring of patient conditions by Informational Communication Technologies (ICT): patient will complete at home a web-based short questionnaire once a week and an expanded version once a month. * Short text messaging to patient's mobile based on information obtained from self-reported questionnaires. 3 types of messages: 1) Reminders for completing web-based questionnaires, the attendance at group sessions and the follow-up appointments, 2) General advice on good habits, 3) Custom messages to reinforce behavior change.
Multifaceted intervention consisting of: * Educational intervention: Two theoretical and practical sessions to update knowledge on T2DM management and provide professionals with techniques to enhance the patient-centered clinical relationship model and the shared decision making model with the ultimate goal of improving patient adherence to treatment and self-care. * Computer-based clinical decision support system (CDSS): Implementation of an automated tool combining evidence-based knowledge with patient-specific information to assist clinicians in making clinical decisions in the management of T2DM patients. * Feedback: periodic mailing of personalized feedback reports with data on health results of all T2DM patients who are cared by the professional.
Usual care for T2DM received in primary health care
Servicio de Evaluación del Servicio Canario de la Salud
Santa Cruz de Tenerife, Spain
Change in Glycosylated hemoglobin (HbA1c)
Change in Glycosylated hemoglobin from baseline to 12 months
Time frame: Baseline and 12 months
Change in Glycosylated hemoglobin (HbA1c)
Time frame: Baseline and 3, 6, 18 and 24 months
Change in Weight
Time frame: Baseline and 3, 6, 12, 18 and 24 months
Change in Waist circumference
Time frame: Baseline and 3, 6, 12, 18 and 24 months
Change in Body Mass Index (BMI)
Time frame: Baseline and 3, 6,12, 18 and 24m
Change in Basal glucose
Time frame: Baseline and 3, 6, 12, 18 and 24 months
Change in Total cholesterol level
Time frame: Baseline and 6, 12 and 24 months
Change in HDL level
Time frame: Baseline and 6, 12 and 24 months
Change in LDL level
Time frame: Baseline and 6, 12 and 24 months
Change in Triglycerides
Time frame: Baseline and 6, 12 and 24 months
Change in EQ-5D index
EQ-5D is a generic questionnaire for health related quality of life (HRQL) assessment
Time frame: Baseline and 6, 12, 18 and 24 months
Change in ADDQoL score
ADDQoL is a specific questionnaire for health related quality of life (HRQL) assessment
Time frame: Baseline and 6, 12, 18 and 24 months
Medication administration
Initiation of new drugs or dosage adjustment: insulin, antidiabetics, hypolipidemics, antihypertensives, etc.
Time frame: Baseline and 6, 12, 18 and 24 months
Change in tabacco consumption
Time frame: Baseline and 3, 6, 12, 18 and 24 months
Acceptability of interventions and satisfaction (INDICA-SATP)
Time frame: 24 months
Change in Diabetes Knowledge
Time frame: Baseline, 12 and 24 months
Change in Mediterranean Diet Adherence Screener (MEDAS) score
Time frame: Baseline and 6, 12, 18 and 24 months
Change in International Physical Activity Questionnarie (IPAQ) score
Time frame: Baseline and 6, 12, 18 and 24 months
Change in Stait-Trait Anxiety Inventory (STAI) score
Time frame: Baseline, 12 and 24 months
Change in Beck Depression Inventory - II (BDI-II) score
Time frame: Baseline, 12 and 24 months
Change in Diabetes Distress Scale (DDS2) score
Time frame: Baseline, 12 and 24 months
Change in Diabetes Empowerment Scale - Short Form (DES-SF) score
Time frame: Baseline, 12 and 24 months
Change in Morisky Compliance Scale
Time frame: Baseline and 6, 12, 18 and 24 months
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