INDICA: Tertiary Prevention in Type II Diabetes Mellitus in Canary Islands Study

Sponsor

Servicio Canario de Salud (Other)

Overall Status

Completed

CT.gov ID

NCT01657227

Collaborator

Instituto de Salud Carlos III (Other), Asociación para la Diabetes de Tenerife (Other), Asociación de Diabéticos de Gran Canaria (Other)

2,334

Enrollment

Location

Arms

45.6

Duration (Months)

51.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Behavioral: Intervention to patients Behavioral: Intervention to professionals Other: Usual care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

2334 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Oct 20, 2016

Actual Study Completion Date :

Oct 20, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention to Patients Only patients receive 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. Other: Usual care Usual care for T2DM received in primary health care
Experimental: 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	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. Other: Usual care Usual care for T2DM received in primary health care
Experimental: Mixed Intervention Patients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive 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. 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. Other: Usual care Usual care for T2DM received in primary health care
Other: Control Patients receive usual care	Other: Usual care Usual care for T2DM received in primary health care

Outcome Measures

Primary Outcome Measures

Change in Glycosylated hemoglobin (HbA1c) [Baseline and 12 months]
Change in Glycosylated hemoglobin from baseline to 12 months

Secondary Outcome Measures

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
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
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]
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]

Other Outcome Measures

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
Resource utilization and costs [Baseline and 3, 6, 12, 18 and 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Servicio de Evaluación del Servicio Canario de la Salud	Santa Cruz de Tenerife		Spain	38004

Sponsors and Collaborators

Servicio Canario de Salud
Instituto de Salud Carlos III
Asociación para la Diabetes de Tenerife
Asociación de Diabéticos de Gran Canaria

Investigators

Principal Investigator: Pedro G Serrano-Aguilar, MD, PhD, Servicio de Evaluación del Servicio Canario de la Salud
Study Director: Pedro Serrano Aguilar, MD, PhD, Servicio de Evaluación del Servicio Canario de la Salud
Study Chair: Pedro Serrano Aguilar, MD, PhD, Servicio de Evaluación del Servicio Canario de la Salud