Tertiary Prevention in Type II Diabetes Mellitus in Canary Islands Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2334 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-10-20

Brief Summary

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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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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Intervention to Patients

Only patients receive intervention

Group Type EXPERIMENTAL

Intervention to patients

Intervention Type 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.

Usual care

Intervention Type OTHER

Usual care for T2DM received in primary health care

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

Group Type EXPERIMENTAL

Intervention to professionals

Intervention Type 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

Intervention Type OTHER

Usual care for T2DM received in primary health care

Mixed Intervention

Patients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive intervention

Group Type EXPERIMENTAL

Intervention to patients

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

Usual care for T2DM received in primary health care

Control

Patients receive usual care

Group Type OTHER

Usual care

Intervention Type OTHER

Usual care for T2DM received in primary health care

Interventions

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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 Type 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.

Intervention Type BEHAVIORAL

Usual care

Usual care for T2DM received in primary health care

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No