Tertiary Prevention in Type II Diabetes Mellitus in Canary Islands Study

Study Overview
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Intervention to patients
* Behavioral: Intervention to professionals
* Other: Usual care


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention to Patients<br>Only patients receive intervention | Behavioral: Intervention to patients<br>* 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.<br>Other: Usual care<br>* Usual care for T2DM received in primary health care<br>|
| Experimental: Intervention to healthcare Professionals<br>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<br>* 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.<br>Other: Usual care<br>* Usual care for T2DM received in primary health care<br>|
| Experimental: Mixed Intervention<br>Patients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive intervention | Behavioral: Intervention to patients<br>* 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.<br>Behavioral: Intervention to professionals<br>* 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.<br>Other: Usual care<br>* Usual care for T2DM received in primary health care<br>|
| Other: Control<br>Patients receive usual care | Other: Usual care<br>* Usual care for T2DM received in primary health care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated hemoglobin (HbA1c) | Change in Glycosylated hemoglobin from baseline to 12 months | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated hemoglobin (HbA1c) |  | Baseline and 3, 6, 18 and 24 months | 
| Change in Weight |  | Baseline and 3, 6, 12, 18 and 24 months | 
| Change in Waist circumference |  | Baseline and 3, 6, 12, 18 and 24 months | 
| Change in Body Mass Index (BMI) |  | Baseline and 3, 6,12, 18 and 24m | 
| Change in Basal glucose |  | Baseline and 3, 6, 12, 18 and 24 months | 
| Change in Total cholesterol level |  | Baseline and 6, 12 and 24 months | 
| Change in HDL level |  | Baseline and 6, 12 and 24 months | 
| Change in LDL level |  | Baseline and 6, 12 and 24 months | 
| Change in Triglycerides |  | Baseline and 6, 12 and 24 months | 
| Change in EQ-5D index | EQ-5D is a generic questionnaire for health related quality of life (HRQL) assessment | Baseline and 6, 12, 18 and 24 months | 
| Change in ADDQoL score | ADDQoL is a specific questionnaire for health related quality of life (HRQL) assessment | Baseline and 6, 12, 18 and 24 months | 
| Medication administration | Initiation of new drugs or dosage adjustment: insulin, antidiabetics, hypolipidemics, antihypertensives, etc. | Baseline and 6, 12, 18 and 24 months | 
| Change in tabacco consumption |  | Baseline and 3, 6, 12, 18 and 24 months | 
| Acceptability of interventions and satisfaction (INDICA-SATP) |  | 24 months | 
| Change in Diabetes Knowledge |  | Baseline, 12 and 24 months | 
| Change in Mediterranean Diet Adherence Screener (MEDAS) score |  | Baseline and 6, 12, 18 and 24 months | 
| Change in International Physical Activity Questionnarie (IPAQ) score |  | Baseline and 6, 12, 18 and 24 months | 
| Change in Stait-Trait Anxiety Inventory (STAI) score |  | Baseline, 12 and 24 months | 
| Change in Beck Depression Inventory - II (BDI-II) score |  | Baseline, 12 and 24 months | 
| Change in Diabetes Distress Scale (DDS2) score |  | Baseline, 12 and 24 months | 
| Change in Diabetes Empowerment Scale - Short Form (DES-SF) score |  | Baseline, 12 and 24 months | 
| Change in Morisky Compliance Scale |  | Baseline and 6, 12, 18 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, self-management, lifestyle, diet, physical exercise, computer-assisted decision support systems