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

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
 Behavioral: Intervention to patients
Behavioral: Intervention to professionals
Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effectiveness and Cost-effectiveness of Two Multi-component Interventions to Improve the Health Outcomes in People With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Servicio Canario de Salud:

Primary Outcome Measures:
  • Glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline and 6,12,24 and 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 2880
Study Start Date: January 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention to Patients
Only patients receive intervention
 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.
Other: Usual care
Usual care for T2DM received in primary health 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
 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: Mixed Intervention
Patients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive intervention
 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
Control
Patients receive usual care
 Other: Usual care
Usual care for T2DM received in primary health care

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657227

Contacts
Contact: Yolanda Ramallo-Fariña +34 922 684095 yramfar@sescs.es
Contact: Lidia García-Pérez +34 922 684095 lidia.garciaperez@sescs.es

Locations
Spain
Servicio de Evaluación del Servicio Canario de la Salud Recruiting
Santa Cruz de Tenerife, Spain, 38004
Contact: Pedro G Serrano-Aguilar, MD,PhD     +34-922 475715     pserrano@gobiernodecanarias.org    
Sponsors and Collaborators
Servicio Canario de Salud
Instituto de Salud Carlos III
Federación de Asociaciones de Diabetes de Canarias (FAdiCAN)
Investigators
Principal Investigator: Pedro G Serrano-Aguilar, MD, PhD Servicio de Evaluación del Servicio Canario de la Salud
  More Information

No publications provided

Responsible Party: Servicio Canario de Salud
ClinicalTrials.gov Identifier: NCT01657227     History of Changes
Other Study ID Numbers: ADE10 00032
Study First Received: July 31, 2012
Last Updated: January 25, 2013
Health Authority: Spain: Instituto de Salud Carlos III. Ministerio de Economia y Competitividad

Keywords provided by Servicio Canario de Salud:
diabetes
self-management
lifestyle
 diet
physical exercise
computer-assisted decision support systems

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013