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Completed

NCT Number: NCT01657227

Tertiary Prevention in Type II Diabetes Mellitus in Canary Islands Study

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Servicio de Evaluación del Servicio Canario de la Salud

Santa Cruz de Tenerife, 38004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention to patients

Behavioral

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.

Intervention to professionals

Behavioral

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

Other

Usual care for T2DM received in primary health care

Primary outcomes

  1. Change in Glycosylated hemoglobin (HbA1c)

    Time frame: Baseline and 12 months

    Change in Glycosylated hemoglobin from baseline to 12 months

Secondary outcomes

  1. Change in Glycosylated hemoglobin (HbA1c)

    Time frame: Baseline and 3, 6, 18 and 24 months

  2. Change in Weight

    Time frame: Baseline and 3, 6, 12, 18 and 24 months

  3. Change in Waist circumference

    Time frame: Baseline and 3, 6, 12, 18 and 24 months

  4. Change in Body Mass Index (BMI)

    Time frame: Baseline and 3, 6,12, 18 and 24m

  5. Change in Basal glucose

    Time frame: Baseline and 3, 6, 12, 18 and 24 months

  6. Change in Total cholesterol level

    Time frame: Baseline and 6, 12 and 24 months

  7. Change in HDL level

    Time frame: Baseline and 6, 12 and 24 months

  8. Change in LDL level

    Time frame: Baseline and 6, 12 and 24 months

  9. Change in Triglycerides

    Time frame: Baseline and 6, 12 and 24 months

  10. 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

  11. 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

  12. Medication administration

    Time frame: Baseline and 6, 12, 18 and 24 months

    Initiation of new drugs or dosage adjustment: insulin, antidiabetics, hypolipidemics, antihypertensives, etc.

  13. Change in tabacco consumption

    Time frame: Baseline and 3, 6, 12, 18 and 24 months

  14. Acceptability of interventions and satisfaction (INDICA-SATP)

    Time frame: 24 months

  15. Change in Diabetes Knowledge

    Time frame: Baseline, 12 and 24 months

  16. Change in Mediterranean Diet Adherence Screener (MEDAS) score

    Time frame: Baseline and 6, 12, 18 and 24 months

  17. Change in International Physical Activity Questionnarie (IPAQ) score

    Time frame: Baseline and 6, 12, 18 and 24 months

  18. Change in Stait-Trait Anxiety Inventory (STAI) score

    Time frame: Baseline, 12 and 24 months

  19. Change in Beck Depression Inventory - II (BDI-II) score

    Time frame: Baseline, 12 and 24 months

  20. Change in Diabetes Distress Scale (DDS2) score

    Time frame: Baseline, 12 and 24 months

  21. Change in Diabetes Empowerment Scale - Short Form (DES-SF) score

    Time frame: Baseline, 12 and 24 months

  22. Change in Morisky Compliance Scale

    Time frame: Baseline and 6, 12, 18 and 24 months

Other outcomes

  1. 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

  2. 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

  3. Resource utilization and costs

    Time frame: Baseline and 3, 6, 12, 18 and 24 months

Sponsors and collaborators

Lead sponsor

Servicio Canario de Salud

Other

Collaborators

  • Asociación de Diabéticos de Gran Canaria
  • Asociación para la Diabetes de Tenerife
  • Instituto de Salud Carlos III

Registry information

Official study title

Effectiveness and Cost-effectiveness of Two Multi-component Interventions to Improve the Health Outcomes in People With Type 2 Diabetes Mellitus

Acronym: INDICA

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 6, 2012
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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