Clinical trial NCT01657227: Tertiary Prevention in Type II Diabetes Mellitus in Canary Islands Study
Official title: Effectiveness and Cost-effectiveness of Two Multi-component Interventions to Improve the Health Outcomes in People With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
self-management
lifestyle
diet
physical exercise
computer-assisted decision support systems
Lead sponsor: Servicio Canario de Salud
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Asociación para la Diabetes de Tenerife
name: Asociación de Diabéticos de Gran Canaria
First posted: 2012-08-06
Enrollment: 2334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Glycosylated hemoglobin (HbA1c)
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in Glycosylated hemoglobin (HbA1c)
timeFrame: Baseline and 3, 6, 18 and 24 months
measure: Change in Weight
timeFrame: Baseline and 3, 6, 12, 18 and 24 months
measure: Change in Waist circumference
timeFrame: Baseline and 3, 6, 12, 18 and 24 months
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline and 3, 6,12, 18 and 24m
measure: Change in Basal glucose
timeFrame: Baseline and 3, 6, 12, 18 and 24 months
measure: Change in Total cholesterol level
timeFrame: Baseline and 6, 12 and 24 months
measure: Change in HDL level
timeFrame: Baseline and 6, 12 and 24 months
measure: Change in LDL level
timeFrame: Baseline and 6, 12 and 24 months
measure: Change in Triglycerides
timeFrame: Baseline and 6, 12 and 24 months
measure: Change in EQ-5D index
timeFrame: Baseline and 6, 12, 18 and 24 months
measure: Change in ADDQoL score
timeFrame: Baseline and 6, 12, 18 and 24 months
measure: Medication administration
timeFrame: Baseline and 6, 12, 18 and 24 months
measure: Change in tabacco consumption
timeFrame: Baseline and 3, 6, 12, 18 and 24 months
measure: Acceptability of interventions and satisfaction (INDICA-SATP)
timeFrame: 24 months
measure: Change in Diabetes Knowledge
timeFrame: Baseline, 12 and 24 months
measure: Change in Mediterranean Diet Adherence Screener (MEDAS) score
timeFrame: Baseline and 6, 12, 18 and 24 months
measure: Change in International Physical Activity Questionnarie (IPAQ) score
timeFrame: Baseline and 6, 12, 18 and 24 months
measure: Change in Stait-Trait Anxiety Inventory (STAI) score
timeFrame: Baseline, 12 and 24 months
measure: Change in Beck Depression Inventory - II (BDI-II) score
timeFrame: Baseline, 12 and 24 months
measure: Change in Diabetes Distress Scale (DDS2) score
timeFrame: Baseline, 12 and 24 months
measure: Change in Diabetes Empowerment Scale - Short Form (DES-SF) score
timeFrame: Baseline, 12 and 24 months
measure: Change in Morisky Compliance Scale
timeFrame: Baseline and 6, 12, 18 and 24 months
Other outcomes:
measure: Incidence of micro- and macrovascular complications
timeFrame: Baseline, 12 and 24 months
measure: Quality measures of the T2DM care process
timeFrame: Baseline and 6, 12, 18 and 24 months
measure: Resource utilization and costs
timeFrame: Baseline and 3, 6, 12, 18 and 24 months
Locations:
city: Santa Cruz de Tenerife
country: Spain
facility: Servicio de Evaluación del Servicio Canario de la Salud
Study officials:
affiliation: Servicio de Evaluación del Servicio Canario de la Salud
name: Pedro G Serrano-Aguilar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio de Evaluación del Servicio Canario de la Salud
name: Pedro Serrano Aguilar, MD, PhD
role: STUDY_DIRECTOR
affiliation: Servicio de Evaluación del Servicio Canario de la Salud
name: Pedro Serrano Aguilar, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.