Tertiary Prevention in Type II Diabetes Mellitus in Canary Islands Study (INDICA)

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Intervention to patients; Other: Usual care; Behavioral: Intervention to professionals

• Study Type: Interventional
• Enrollment (Actual): 2334
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Santa Cruz de Tenerife, Spain, 38004
    • Servicio de Evaluación del Servicio Canario de la Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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	Other: Usual care; Usual care for T2DM received in primary health care; 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.
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.; Other: Usual care; Usual care for T2DM received in primary health care; 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: Control; Patients receive usual care	Other: Usual care; Usual care for T2DM received in primary health care

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of micro- and macrovascular complications	Coronary events, peripheral vascular complications, cerebral vascular complications, diabetic retinopathy, diabetic nephropathy	Baseline, 12 and 24 months
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
Resource utilization and costs		Baseline and 3, 6, 12, 18 and 24 months

Collaborators and Investigators

• Sponsor: Servicio Canario de Salud
• Collaborators: 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

Publications and helpful links

General Publications

• García-Pérez L, Ramallo-Fariña Y, Vallejo-Torres L, Rodríguez-Rodríguez L, González-Pacheco H, Santos-Hernández B, García-Bello MA, Wägner AM, Carmona M, Serrano-Aguilar PG; INDICA team. Cost-effectiveness of multicomponent interventions in type 2 diabetes mellitus in a cluster randomised controlled trial: the INDICA study. BMJ Open. 2022 Apr 8;12(4):e058049. doi: 10.1136/bmjopen-2021-058049.
• Ramallo-Farina Y, Rivero-Santana A, Garcia-Perez L, Garcia-Bello MA, Wagner AM, Gonzalez-Pacheco H, Rodriguez-Rodriguez L, Kaiser-Girardot S, Monzon-Monzon G, Guerra-Marrero C, Daranas-Aguilar C, Roldan-Ruano M, Carmona M, Serrano-Aguilar PG; INDICA Team. Patient-reported outcome measures for knowledge transfer and behaviour modification interventions in type 2 diabetes-the INDICA study: a multiarm cluster randomised controlled trial. BMJ Open. 2021 Dec 15;11(12):e050804. doi: 10.1136/bmjopen-2021-050804.
• Ramallo-Farina Y, Garcia-Bello MA, Garcia-Perez L, Boronat M, Wagner AM, Rodriguez-Rodriguez L, de Pablos-Velasco P, Llorente Gomez de Segura I, Gonzalez-Pacheco H, Carmona Rodriguez M, Serrano-Aguilar P; INDICA Team. Effectiveness of Internet-Based Multicomponent Interventions for Patients and Health Care Professionals to Improve Clinical Outcomes in Type 2 Diabetes Evaluated Through the INDICA Study: Multiarm Cluster Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Nov 2;8(11):e18922. doi: 10.2196/18922.
• Ramallo-Farina Y, Garcia-Perez L, Castilla-Rodriguez I, Perestelo-Perez L, Wagner AM, de Pablos-Velasco P, Dominguez AC, Cortes MB, Vallejo-Torres L, Ramirez ME, Martin PP, Garcia-Puente I, Salinero-Fort MA, Serrano-Aguilar PG; INDICA team. Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients--the INDICA study: a cluster randomized controlled trial. Implement Sci. 2015 Apr 9;10:47. doi: 10.1186/s13012-015-0233-1.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): October 20, 2016
• Study Completion (Actual): October 20, 2016

Study Registration Dates

• First Submitted: July 31, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimate): August 6, 2012

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: diabetes; self-management; diet; physical exercise; lifestyle; computer-assisted decision support systems
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ADE10 00032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided