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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Servicio Canario de Salud
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Federación de Asociaciones de Diabetes de Canarias (FAdiCAN)
Information provided by (Responsible Party):
Servicio Canario de Salud
ClinicalTrials.gov Identifier:
NCT01657227
First received: July 31, 2012
Last updated: January 25, 2013
Last verified: January 2013

July 31, 2012
January 25, 2013
January 2013
March 2015   (final data collection date for primary outcome measure)
Glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline and 6,12,24 and 36 months ] [ Designated as safety issue: No ]
Change from baseline in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline and 6,12,24 and 36 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01657227 on ClinicalTrials.gov Archive Site
  • Weight [ Designated as safety issue: No ]
  • Waist circumference [ Designated as safety issue: No ]
  • Body Mass Index (BMI) [ Designated as safety issue: No ]
  • Glycemia [ Designated as safety issue: No ]
  • Total cholesterol level [ Designated as safety issue: No ]
  • HDL level [ Designated as safety issue: No ]
  • LDL level [ Designated as safety issue: No ]
  • Triglycerides [ Designated as safety issue: No ]
  • EQ-5D questionnaire [ Designated as safety issue: No ]
    EQ-5D is a generic questionnaire for health related quality of life (HRQL) assessment
  • ADDQoL questionnaire [ Designated as safety issue: No ]
    ADDQoL is a specific questionnaire for health related quality of life (HRQL) assessment
  • Medication administration [ Designated as safety issue: No ]
    Initiation of new drugs or dosage adjustment: insulin, antidiabetics, hypolipidemics, antihypertensives, etc.
  • Lifestyle habits [ Designated as safety issue: No ]
    Nutrition, physical activity, abandonment or reduction of tabacco consumption, etc.
  • Acceptability of interventions and satisfaction [ Designated as safety issue: No ]
  • Diabetes Knowledge [ Designated as safety issue: No ]
  • Changes from baseline in weight [ Designated as safety issue: No ]
  • Changes from baseline in waist circumference [ Designated as safety issue: No ]
  • Change from baseline in waist-hip ratio index [ Designated as safety issue: No ]
  • Change from baseline in glycemia [ Designated as safety issue: No ]
  • Change from baseline in total cholesterol level [ Designated as safety issue: No ]
  • Change from baseline in HDL level [ Designated as safety issue: No ]
  • Change from baseline in LDL level [ Designated as safety issue: No ]
  • Change from baseline in triglycerides [ Designated as safety issue: No ]
  • Change from baseline in albumin [ Designated as safety issue: No ]
  • Change from baseline in EQ-5D questionnaire [ Designated as safety issue: No ]
    EQ-5D is a generic questionnaire for ealth related quality of life (HRQL) assessment
  • Change from baseline in ADDQoL questionnaire [ Designated as safety issue: No ]
    ADDQoL is a specific questionnaire for ealth related quality of life (HRQL) assessment
  • Changes from baseline in medication administration [ Designated as safety issue: No ]
    Initiation of new drugs or dosage adjustment: insulin, antidiabetics, hipolipides, antihypertensives and/or antiproteinuric
  • Change in lifestyle habits [ Designated as safety issue: No ]
    Nutrition, physical activity, abandonment or reduction of tabacco consumption, etc.
  • Acceptability of interventions and satisfaction [ Designated as safety issue: No ]
  • Incidence of micro- and macrovascular complications [ Designated as safety issue: No ]
    Coronary events, peripheral vascular complications, cerebral vascular complications, diabetic retinopathy, diabetic nephropathy
  • Quality measures of the T2DM care process [ Designated as safety issue: No ]
    Adherence to recommendations on physical exam, lab test and treatment
  • Resource utilization and costs [ Designated as safety issue: No ]
  • Incidence of micro- and macrovascular complications [ Designated as safety issue: Yes ]
    Coronary events, peripheral vascular complications, cerebral vascular complications, diabetic retinopathy, diabetic nephropathy
  • Quality measures of the T2DM care process [ Designated as safety issue: No ]
    Adherence to recommendations on physical exam, lab test and treatment
  • Resource utilization and costs [ Designated as safety issue: No ]
  • Professional level of the PHCT [ Designated as safety issue: No ]
    Years of experience, continuing professional education extent, etc.
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Type 2 Diabetes Mellitus
  • Behavioral: Intervention to patients

    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.
  • Behavioral: Intervention to professionals

    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.
  • Other: Usual care
    Usual care for T2DM received in primary health care
  • Experimental: Intervention to Patients
    Only patients receive intervention
    Interventions:
    • Behavioral: Intervention to patients
    • Other: Usual care
  • Experimental: Intervention to healthcare Professionals
    Primary care physicians and nurses practitioners receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals
    Interventions:
    • Behavioral: Intervention to professionals
    • Other: Usual care
  • Experimental: Mixed Intervention
    Patients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive intervention
    Interventions:
    • Behavioral: Intervention to patients
    • Behavioral: Intervention to professionals
    • Other: Usual care
  • Control
    Patients receive usual care
    Intervention: Other: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2880
September 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Yolanda Ramallo-Fariña +34 922 684095 yramfar@sescs.es
Contact: Lidia García-Pérez +34 922 684095 lidia.garciaperez@sescs.es
Spain
 
NCT01657227
ADE10 00032
No
Servicio Canario de Salud
Servicio Canario de Salud
  • Instituto de Salud Carlos III
  • Federación de Asociaciones de Diabetes de Canarias (FAdiCAN)
Principal Investigator: Pedro G Serrano-Aguilar, MD, PhD Servicio de Evaluación del Servicio Canario de la Salud
Servicio Canario de Salud
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP