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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| Asociación para la Diabetes de Tenerife | UNKNOWN |
| Asociación de Diabéticos de Gran Canaria | UNKNOWN |
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Objective:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention to Patients | Experimental | Only patients receive intervention |
|
| Intervention to healthcare Professionals | Experimental | Primary care physicians and nurses practitioners receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals |
|
| Mixed Intervention | Experimental | Patients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive intervention |
|
| Control | Other | Patients receive usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention to patients | Behavioral | Multifaceted intervention consisting of:
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated hemoglobin (HbA1c) | Change in Glycosylated hemoglobin from baseline to 12 months | Baseline and 12 months |
| 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 |
| 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 |
Inclusion Criteria:
Patients:
Health professionals:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro G Serrano-Aguilar, MD, PhD | Servicio de Evaluación del Servicio Canario de la Salud | Principal Investigator |
| Pedro 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio de Evaluación del Servicio Canario de la Salud | Santa Cruz de Tenerife | 38004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35396305 | Derived | Garcia-Perez L, Ramallo-Farina Y, Vallejo-Torres L, Rodriguez-Rodriguez L, Gonzalez-Pacheco H, Santos-Hernandez B, Garcia-Bello MA, Wagner 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. | |
| 34911711 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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.
|
| Intervention to professionals | Behavioral | Multifaceted intervention consisting of:
|
|
| Usual care | Other | Usual care for T2DM received in primary health care |
|
| 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 |
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 |
| Derived |
| 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. |
| 33136059 | Derived | 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. |
| 25880498 | Derived | 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. |
| D001519 | Behavior |