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Type 2 Diabetes MellitusINDICANCT01657227

Tertiary Prevention in Type II Diabetes Mellitus in Canary Islands Study

A study testing Intervention to patients and Intervention to professionals in people with Type 2 Diabetes Mellitus, run by Servicio Canario de Salud at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Intervention to patients and Intervention to professionals
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,334 participants
Where
1 siteSpain
Study dates
Jan 2013to 20 Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • cancer last 5 years
  • ischemic disease or heart failure
  • proliferative diabetic retinopathy

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Servicio de Evaluación del Servicio Canario de la Salud

    Santa Cruz de Tenerife, 38004

Other trials in Spain

About this study

Official title: 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.
Read more

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.

Being tested
Intervention to patients, Intervention to professionals, Usual care
Keywords
diabetes, self-management, lifestyle, diet, physical exercise, computer-assisted decision support systems
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention to patientsBehavioural

    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 professionalsBehavioural

    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.

  • Usual careOther

    Usual care for T2DM received in primary health care

Study groups in NCT01657227
Study groupRoleWhat they receive
Intervention to PatientsExperimentalOnly patients receive intervention
Receives: Behavioral: Intervention to patients; Other: Usual care
Intervention to healthcare ProfessionalsExperimentalPrimary care physicians and nurses practitioners receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals
Receives: Behavioral: Intervention to professionals; Other: Usual care
Mixed InterventionExperimentalPatients and healthcare professionals (primary care physicians and nurses practitioners) associated with these patients receive intervention
Receives: Behavioral: Intervention to patients; Behavioral: Intervention to professionals; Other: Usual care
ControlOtherPatients receive usual care
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glycosylated hemoglobin (HbA1c)

    Change in Glycosylated hemoglobin from baseline to 12 months

    Measured: Baseline and 12 months

Secondary outcomes (22)

  1. Change in Glycosylated hemoglobin (HbA1c)

    Measured: Baseline and 3, 6, 18 and 24 months

  2. Change in Weight

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

  3. Change in Waist circumference

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

  4. Change in Body Mass Index (BMI)

    Measured: Baseline and 3, 6,12, 18 and 24m

  5. Change in Basal glucose

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

  6. Change in Total cholesterol level

    Measured: Baseline and 6, 12 and 24 months

  7. Change in HDL level

    Measured: Baseline and 6, 12 and 24 months

  8. Change in LDL level

    Measured: Baseline and 6, 12 and 24 months

  9. Change in Triglycerides

    Measured: Baseline and 6, 12 and 24 months

  10. Change in EQ-5D index

    EQ-5D is a generic questionnaire for health related quality of life (HRQL) assessment

    Measured: Baseline and 6, 12, 18 and 24 months

  11. Change in ADDQoL score

    ADDQoL is a specific questionnaire for health related quality of life (HRQL) assessment

    Measured: Baseline and 6, 12, 18 and 24 months

  12. Medication administration

    Initiation of new drugs or dosage adjustment: insulin, antidiabetics, hypolipidemics, antihypertensives, etc.

    Measured: Baseline and 6, 12, 18 and 24 months

  13. Change in tabacco consumption

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

  14. Acceptability of interventions and satisfaction (INDICA-SATP)

    Measured: 24 months

  15. Change in Diabetes Knowledge

    Measured: Baseline, 12 and 24 months

  16. Change in Mediterranean Diet Adherence Screener (MEDAS) score

    Measured: Baseline and 6, 12, 18 and 24 months

  17. Change in International Physical Activity Questionnarie (IPAQ) score

    Measured: Baseline and 6, 12, 18 and 24 months

  18. Change in Stait-Trait Anxiety Inventory (STAI) score

    Measured: Baseline, 12 and 24 months

  19. Change in Beck Depression Inventory - II (BDI-II) score

    Measured: Baseline, 12 and 24 months

  20. Change in Diabetes Distress Scale (DDS2) score

    Measured: Baseline, 12 and 24 months

  21. Change in Diabetes Empowerment Scale - Short Form (DES-SF) score

    Measured: Baseline, 12 and 24 months

  22. Change in Morisky Compliance Scale

    Measured: Baseline and 6, 12, 18 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2012 (estimated)
  2. Study startJan 2013
  3. Primary completion20 Oct 2016
  4. Study completion20 Oct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01657227
Sponsor's protocol ID
ADE10 00032
Acronym
INDICA
Status last verified
Sep 2021
First submitted
31 Jul 2012
Last updated
4 Oct 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35396305

  • 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.

    PubMed 34911711

  • 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.

    PubMed 33136059

  • 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.

    PubMed 25880498

Questions about this trial

What is this clinical trial studying?

A study testing Intervention to patients and Intervention to professionals in people with Type 2 Diabetes Mellitus, run by Servicio Canario de Salud at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycosylated hemoglobin (HbA1c) (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01657227, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.

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