Tertiary Prevention in Type II Diabetes Mellitus in Canary Islands Study (INDICA)

Servicio Canario de Salud

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Intervention to professionals; Behavioral: Intervention to patients; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT01657227

ADE10 00032

Details and patient eligibility

About

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.

Enrollment: 2,334 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,334 participants in 4 patient groups

Intervention to Patients

Experimental group

Description:

Only patients receive intervention

Treatment:

Other: Usual care

Behavioral: Intervention to patients

Intervention to healthcare Professionals

Experimental group

Description:

Primary care physicians and nurses practitioners receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals

Treatment:

Other: Usual care

Behavioral: Intervention to professionals

Mixed Intervention

Experimental group

Description:

Patients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive intervention

Treatment:

Other: Usual care

Behavioral: Intervention to professionals

Behavioral: Intervention to patients

Control

Other group

Description:

Patients receive usual care

Treatment:

Other: Usual care