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

This study has been completed.
Sponsor:
Collaborators:
Instituto de Salud Carlos III
Asociación para la Diabetes de Tenerife
Asociación de Diabéticos de Gran Canaria
Information provided by (Responsible Party):
Servicio Canario de Salud
ClinicalTrials.gov Identifier:
NCT01657227
First received: July 31, 2012
Last updated: June 6, 2017
Last verified: June 2017
July 31, 2012
June 6, 2017
January 2013
October 20, 2016   (Final data collection date for primary outcome measure)
Change in Glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline and 12 months ]
Change in Glycosylated hemoglobin from baseline to 12 months
Change from baseline in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline and 6,12,24 and 36 months ]
Complete list of historical versions of study NCT01657227 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: Baseline and 6, 12, 18 and 24 months ]
    EQ-5D is a generic questionnaire for health related quality of life (HRQL) assessment
  • Change in ADDQoL score [ Time Frame: Baseline and 6, 12, 18 and 24 months ]
    ADDQoL is a specific questionnaire for health related quality of life (HRQL) assessment
  • Medication administration [ Time Frame: Baseline and 6, 12, 18 and 24 months ]
    Initiation of new drugs or dosage adjustment: insulin, antidiabetics, hypolipidemics, antihypertensives, etc.
  • Change in tabacco consumption [ Time Frame: Baseline and 3, 6, 12, 18 and 24 months ]
  • Acceptability of interventions and satisfaction [ 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 Problem Areas in Diabetes Scale (PAID) 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 ]
  • Changes from baseline in weight
  • Changes from baseline in waist circumference
  • Change from baseline in waist-hip ratio index
  • Change from baseline in glycemia
  • Change from baseline in total cholesterol level
  • Change from baseline in HDL level
  • Change from baseline in LDL level
  • Change from baseline in triglycerides
  • Change from baseline in albumin
  • Change from baseline in EQ-5D questionnaire
    EQ-5D is a generic questionnaire for ealth related quality of life (HRQL) assessment
  • Change from baseline in ADDQoL questionnaire
    ADDQoL is a specific questionnaire for ealth related quality of life (HRQL) assessment
  • Changes from baseline in medication administration
    Initiation of new drugs or dosage adjustment: insulin, antidiabetics, hipolipides, antihypertensives and/or antiproteinuric
  • Change in lifestyle habits
    Nutrition, physical activity, abandonment or reduction of tabacco consumption, etc.
  • Acceptability of interventions and satisfaction
  • Incidence of micro- and macrovascular complications [ Time Frame: Baseline, 12 and 24 months ]
    Coronary events, peripheral vascular complications, cerebral vascular complications, diabetic retinopathy, diabetic nephropathy
  • Quality measures of the T2DM care process [ Time Frame: Baseline and 6, 12, 18 and 24 months ]
    Adherence to recommendations on physical exam, lab test and treatment
  • Resource utilization and costs [ Time Frame: Baseline and 3, 6, 12, 18 and 24 months ]
  • Incidence of micro- and macrovascular complications
    Coronary events, peripheral vascular complications, cerebral vascular complications, diabetic retinopathy, diabetic nephropathy
  • Quality measures of the T2DM care process
    Adherence to recommendations on physical exam, lab test and treatment
  • Resource utilization and costs
  • Professional level of the PHCT
    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
Intervention Model: Parallel Assignment
Masking: Outcomes Assessor
Masking Description:
Participating FCUs were not told about their intervention assignment (groups 1-4) until the last patient agreed to participate at every FCU. To warrant patient participation and cooperation, interventions could neither be blinded to patients nor to healthcare professionals. Data analysis is blinded to the intervention assignment.
Primary Purpose: Prevention
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
Ramallo-Fariña Y, García-Pérez L, Castilla-Rodríguez I, Perestelo-Pérez L, Wägner AM, de Pablos-Velasco P, Domínguez AC, Cortés MB, Vallejo-Torres L, Ramírez ME, Martín PP, García-Puente I, Salinero-Fort MÁ, Serrano-Aguilar PG; INDICA team. Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients--the INDICA study: a cluster randomized controlled trial. Implement Sci. 2015 Apr 9;10:47. doi: 10.1186/s13012-015-0233-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2334
October 20, 2016
October 20, 2016   (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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01657227
ADE10 00032
No
Not Provided
Plan to Share IPD: Undecided
Servicio Canario de Salud
Servicio Canario de Salud
  • Instituto de Salud Carlos III
  • Asociación para la Diabetes de Tenerife
  • Asociación de Diabéticos de Gran Canaria
Principal Investigator: Pedro G Serrano-Aguilar, MD, PhD Servicio de Evaluación del Servicio Canario de la Salud
Study Director: Pedro Serrano Aguilar, MD, PhD Servicio de Evaluación del Servicio Canario de la Salud
Study Chair: Pedro Serrano Aguilar, MD, PhD Servicio de Evaluación del Servicio Canario de la Salud
Servicio Canario de Salud
June 2017

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