Tertiary Prevention in Type II Diabetes Mellitus in Canary Islands Study

NCT01657227 | Completed

• 1 other identifier: ADE10 00032
• Study Type: interventional
• Target: 2,334
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes; self-management; lifestyle; diet; physical exercise; computer-assisted decision support systems

Outcome Measures

Primary Outcomes (1)

• Change in Glycosylated hemoglobin (HbA1c)

  Change in Glycosylated hemoglobin from baseline to 12 months

  Baseline and 12 months

Secondary Outcomes (22)

• 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

Other Outcomes (3)

• Incidence of micro- and macrovascular complications

  Baseline, 12 and 24 months

• Quality measures of the T2DM care process

  Baseline and 6, 12, 18 and 24 months

• Resource utilization and costs

  Baseline and 3, 6, 12, 18 and 24 months

Study Arms (4)

Intervention to Patients

EXPERIMENTAL

Only patients receive intervention

Behavioral: Intervention to patients; Other: Usual care

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

Behavioral: Intervention to professionals; Other: Usual care

Mixed Intervention

EXPERIMENTAL

Patients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive intervention

Behavioral: Intervention to patients; Behavioral: Intervention to professionals; Other: Usual care

Control

OTHER

Patients receive usual care

Other: Usual care

Interventions

Intervention to patients BEHAVIORAL

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.

Intervention to Patients; Mixed Intervention

Intervention to professionals BEHAVIORAL

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.

Intervention to healthcare Professionals; Mixed Intervention

Usual care OTHER

Usual care for T2DM received in primary health care

Control; Intervention to Patients; Intervention to healthcare Professionals; Mixed Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Servicio Canario de Salud: lead
• Instituto de Salud Carlos III: collaborator
• Asociación para la Diabetes de Tenerife: collaborator
• Asociación de Diabéticos de Gran Canaria: collaborator

Study Sites (1)

Servicio de Evaluación del Servicio Canario de la Salud

Santa Cruz de Tenerife, 38004, Spain

Location

Related Publications (4)

• 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.

  PMID: 35396305 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.

  PMID: 34911711 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.

  PMID: 33136059 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.

  PMID: 25880498 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 6, 2012
• Study Start: January 1, 2013
• Primary Completion: October 20, 2016
• Study Completion: October 20, 2016
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

ES (1)