Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, self-management, lifestyle, diet, physical exercise, computer-assisted decision support systems
Brief 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.
Interventions
BEHAVIORALIntervention 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.
BEHAVIORALIntervention 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.
OTHERUsual care
Usual care for T2DM received in primary health care
Sponsors
Instituto de Salud Carlos III
Asociación para la Diabetes de Tenerife
Asociación de Diabéticos de Gran Canaria
Servicio Canario de Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated hemoglobin (HbA1c) | Baseline and 12 months | Change in Glycosylated hemoglobin from baseline to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ADDQoL score | Baseline and 6, 12, 18 and 24 months | ADDQoL is a specific questionnaire for health related quality of life (HRQL) assessment |
| 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 | — |
| 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 | Baseline and 6, 12, 18 and 24 months | EQ-5D is a generic questionnaire for health related quality of life (HRQL) assessment |
| Medication administration | Baseline and 6, 12, 18 and 24 months | Initiation of new drugs or dosage adjustment: insulin, antidiabetics, hypolipidemics, antihypertensives, etc. |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Resource utilization and costs | Baseline and 3, 6, 12, 18 and 24 months | — |
| Incidence of micro- and macrovascular complications | Baseline, 12 and 24 months | Coronary events, peripheral vascular complications, cerebral vascular complications, diabetic retinopathy, diabetic nephropathy |
| Quality measures of the T2DM care process | Baseline and 6, 12, 18 and 24 months | Adherence to recommendations on physical exam, lab test and treatment |
Countries
Spain
Outcome results
None listed