Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments intervention to patients, intervention to professionals, usual care
Sponsor Servicio Canario de Salud
Collaborator Instituto de Salud Carlos III
Start date January 2013
End date July 2016
Trial size 2880 participants
Trial identifier NCT01657227, ADE10 00032

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Experimental)
Only patients receive intervention
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.
usual care
Usual care for T2DM received in primary health care
(Experimental)
Primary care physicians and nurses practitioners receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals
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.
usual care
Usual care for T2DM received in primary health care
(Experimental)
Patients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive intervention
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.
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.
usual care
Usual care for T2DM received in primary health care
(Other)
Patients receive usual care
usual care
Usual care for T2DM received in primary health care

Primary Outcomes

Measure
Glycosylated hemoglobin (HbA1c)
time frame: Baseline and 3, 6, 12, 18 and 24 months

Secondary Outcomes

Measure
Weight
time frame: Baseline and 3, 6, 12, 18 and 24 months
Waist circumference
time frame: Baseline and 3, 6, 12, 18 and 24 months
Body Mass Index (BMI)
time frame: Baseline and 3, 6,12, 18 and 24m
Basal glucose
time frame: Baseline and 3, 6, 12, 18 and 24 months
Total cholesterol level
time frame: Baseline and 6, 12 and 24 months
HDL level
time frame: Baseline and 6, 12 and 24 months
LDL level
time frame: Baseline and 6, 12 and 24 months
Triglycerides
time frame: Baseline and 6, 12 and 24 months
EQ-5D questionnaire
time frame: Baseline and 6, 12, 18 and 24 months
ADDQoL questionnaire
time frame: Baseline and 6, 12, 18 and 24 months
Medication administration
time frame: Baseline and 6, 12, 18 and 24 months
Lifestyle habits
time frame: Baseline and 3, 6, 12, 18 and 24 months
Acceptability of interventions and satisfaction
time frame: 24 months
Diabetes Knowledge
time frame: Baseline, 12 and 24 months
Mediterranean Diet Adherence Screener (MEDAS) questionnaire
time frame: Baseline and 6, 12, 18 and 24 months
International Physical Activity Questionnarie (IPAQ)
time frame: Baseline and 6, 12, 18 and 24 months
Stait-Trait Anxiety Inventory (STAI)
time frame: Baseline, 12 and 24 months
Beck Depression Inventory - II (BDI-II)
time frame: Baseline, 12 and 24 months
Problem Areas in Diabetes Scale (PAID)
time frame: Baseline, 12 and 24 months
Diabetes Empowerment Scale - Short Form (DES-SF)
time frame: Baseline, 12 and 24 months
Morisky Compliance Scale
time frame: Baseline and 6, 12, 18 and 24 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Effectiveness and Cost-effectiveness of Two Multi-component Interventions to Improve the Health Outcomes in People With Type 2 Diabetes Mellitus
Principal investigator Pedro G Serrano-Aguilar, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Servicio Canario de Salud.