Tertiary Prevention in Type II Diabetes Mellitus in Canary Islands Study

Type 2 Diabetes Mellitus Clinical Trial

— INDICA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657227
• Other study ID #: ADE10 00032
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: October 20, 2016

Study information

• Verified date: September 2021
• Source: Servicio Canario de Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2334
• Est. completion date: October 20, 2016
• Est. primary completion date: October 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• 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.

Other:
• Usual care
Usual care for T2DM received in primary health care

Locations

Country	Name	City	State
Spain	Servicio de Evaluación del Servicio Canario de la Salud	Santa Cruz de Tenerife

Sponsors (4)

Lead Sponsor	Collaborator
Servicio Canario de Salud	Asociación de Diabéticos de Gran Canaria, Asociación para la Diabetes de Tenerife, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of micro- and macrovascular complications	Coronary events, peripheral vascular complications, cerebral vascular complications, diabetic retinopathy, diabetic nephropathy	Baseline, 12 and 24 months
Other	Quality measures of the T2DM care process	Adherence to recommendations on physical exam, lab test and treatment	Baseline and 6, 12, 18 and 24 months
Other	Resource utilization and costs		Baseline and 3, 6, 12, 18 and 24 months
Primary	Change in Glycosylated hemoglobin (HbA1c)	Change in Glycosylated hemoglobin from baseline to 12 months	Baseline and 12 months
Secondary	Change in Glycosylated hemoglobin (HbA1c)		Baseline and 3, 6, 18 and 24 months
Secondary	Change in Weight		Baseline and 3, 6, 12, 18 and 24 months
Secondary	Change in Waist circumference		Baseline and 3, 6, 12, 18 and 24 months
Secondary	Change in Body Mass Index (BMI)		Baseline and 3, 6,12, 18 and 24m
Secondary	Change in Basal glucose		Baseline and 3, 6, 12, 18 and 24 months
Secondary	Change in Total cholesterol level		Baseline and 6, 12 and 24 months
Secondary	Change in HDL level		Baseline and 6, 12 and 24 months
Secondary	Change in LDL level		Baseline and 6, 12 and 24 months
Secondary	Change in Triglycerides		Baseline and 6, 12 and 24 months
Secondary	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
Secondary	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
Secondary	Medication administration	Initiation of new drugs or dosage adjustment: insulin, antidiabetics, hypolipidemics, antihypertensives, etc.	Baseline and 6, 12, 18 and 24 months
Secondary	Change in tabacco consumption		Baseline and 3, 6, 12, 18 and 24 months
Secondary	Acceptability of interventions and satisfaction (INDICA-SATP)		24 months
Secondary	Change in Diabetes Knowledge		Baseline, 12 and 24 months
Secondary	Change in Mediterranean Diet Adherence Screener (MEDAS) score		Baseline and 6, 12, 18 and 24 months
Secondary	Change in International Physical Activity Questionnarie (IPAQ) score		Baseline and 6, 12, 18 and 24 months
Secondary	Change in Stait-Trait Anxiety Inventory (STAI) score		Baseline, 12 and 24 months
Secondary	Change in Beck Depression Inventory - II (BDI-II) score		Baseline, 12 and 24 months
Secondary	Change in Diabetes Distress Scale (DDS2) score		Baseline, 12 and 24 months
Secondary	Change in Diabetes Empowerment Scale - Short Form (DES-SF) score		Baseline, 12 and 24 months
Secondary	Change in Morisky Compliance Scale		Baseline and 6, 12, 18 and 24 months