- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01657227
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Santa Cruz de Tenerife, Spain, 38004
- Servicio de Evaluación del Servicio Canario de la Salud
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention to Patients
Only patients receive intervention
|
Multifaceted intervention consisting of:
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
|
Usual care for T2DM received in primary health care
Multifaceted intervention consisting of:
|
Experimental: Mixed Intervention
Patients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive intervention
|
Multifaceted intervention consisting of:
Usual care for T2DM received in primary health care
Multifaceted intervention consisting of:
|
Other: Control
Patients receive 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)
Time Frame: Baseline and 12 months
|
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)
Time Frame: Baseline and 3, 6, 18 and 24 months
|
Baseline and 3, 6, 18 and 24 months
|
|
Change in Weight
Time Frame: Baseline and 3, 6, 12, 18 and 24 months
|
Baseline and 3, 6, 12, 18 and 24 months
|
|
Change in Waist circumference
Time Frame: Baseline and 3, 6, 12, 18 and 24 months
|
Baseline and 3, 6, 12, 18 and 24 months
|
|
Change in Body Mass Index (BMI)
Time Frame: Baseline and 3, 6,12, 18 and 24m
|
Baseline and 3, 6,12, 18 and 24m
|
|
Change in Basal glucose
Time Frame: Baseline and 3, 6, 12, 18 and 24 months
|
Baseline and 3, 6, 12, 18 and 24 months
|
|
Change in Total cholesterol level
Time Frame: Baseline and 6, 12 and 24 months
|
Baseline and 6, 12 and 24 months
|
|
Change in HDL level
Time Frame: Baseline and 6, 12 and 24 months
|
Baseline and 6, 12 and 24 months
|
|
Change in LDL level
Time Frame: Baseline and 6, 12 and 24 months
|
Baseline and 6, 12 and 24 months
|
|
Change in Triglycerides
Time Frame: Baseline and 6, 12 and 24 months
|
Baseline and 6, 12 and 24 months
|
|
Change in EQ-5D index
Time Frame: Baseline and 6, 12, 18 and 24 months
|
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
Time Frame: Baseline and 6, 12, 18 and 24 months
|
ADDQoL is a specific questionnaire for health related quality of life (HRQL) assessment
|
Baseline and 6, 12, 18 and 24 months
|
Medication administration
Time Frame: Baseline and 6, 12, 18 and 24 months
|
Initiation of new drugs or dosage adjustment: insulin, antidiabetics, hypolipidemics, antihypertensives, etc.
|
Baseline and 6, 12, 18 and 24 months
|
Change in tabacco consumption
Time Frame: Baseline and 3, 6, 12, 18 and 24 months
|
Baseline and 3, 6, 12, 18 and 24 months
|
|
Acceptability of interventions and satisfaction (INDICA-SATP)
Time Frame: 24 months
|
24 months
|
|
Change in Diabetes Knowledge
Time Frame: Baseline, 12 and 24 months
|
Baseline, 12 and 24 months
|
|
Change in Mediterranean Diet Adherence Screener (MEDAS) score
Time Frame: Baseline and 6, 12, 18 and 24 months
|
Baseline and 6, 12, 18 and 24 months
|
|
Change in International Physical Activity Questionnarie (IPAQ) score
Time Frame: Baseline and 6, 12, 18 and 24 months
|
Baseline and 6, 12, 18 and 24 months
|
|
Change in Stait-Trait Anxiety Inventory (STAI) score
Time Frame: Baseline, 12 and 24 months
|
Baseline, 12 and 24 months
|
|
Change in Beck Depression Inventory - II (BDI-II) score
Time Frame: Baseline, 12 and 24 months
|
Baseline, 12 and 24 months
|
|
Change in Diabetes Distress Scale (DDS2) score
Time Frame: Baseline, 12 and 24 months
|
Baseline, 12 and 24 months
|
|
Change in Diabetes Empowerment Scale - Short Form (DES-SF) score
Time Frame: Baseline, 12 and 24 months
|
Baseline, 12 and 24 months
|
|
Change in Morisky Compliance Scale
Time Frame: Baseline and 6, 12, 18 and 24 months
|
Baseline and 6, 12, 18 and 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of micro- and macrovascular complications
Time Frame: Baseline, 12 and 24 months
|
Coronary events, peripheral vascular complications, cerebral vascular complications, diabetic retinopathy, diabetic nephropathy
|
Baseline, 12 and 24 months
|
Quality measures of the T2DM care process
Time Frame: Baseline and 6, 12, 18 and 24 months
|
Adherence to recommendations on physical exam, lab test and treatment
|
Baseline and 6, 12, 18 and 24 months
|
Resource utilization and costs
Time Frame: Baseline and 3, 6, 12, 18 and 24 months
|
Baseline and 3, 6, 12, 18 and 24 months
|
Collaborators and Investigators
Sponsor
Collaborators
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
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADE10 00032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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