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Diabetes Mellitus, Type 2Edep-TiNCT03453970

Effectiveness of a Diabetes Education Program Based on Tailored Interventions (Edep-Ti Study)

A study testing Therapeutic Education Program in people with Diabetes Mellitus, Type 2, run by University of Malaga 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

GOALS: PRIMARY: 1. Analyze the overall impact of the proposed diabetes education program on metabolic control (HbA1c) and modifiable cardiovascular risk factors (lipid profile and blood pressure). SECONDARY: 2. Evaluate the effectiveness of the program on smoking habits and body mass index (weight, height). 3. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Therapeutic Education Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
410 participants
Where
1 siteSpain
Study dates
1 Dec 2018to 31 Dec 2021
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with Type II Diabetes Mellitus diagnosed <10 years and classified in a computerized clinical history with poor metabolic control (HbA1c> 7% or BMI > 27.5) and in treatment with oral antidiabetics.

Who cannot join

  • Diabetes Mellitus type 1
  • Insulinized patients.
  • Patients who have received some type of structured educational intervention in the last year according to the data obtained in their clinical history.
  • Patients with some type of sensory or mental disability.
  • Gestational diabetes.
  • Patients with age equal to or greater than 75 years of age or minors.
  • Patients with inability to travel to their Health Center.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Public Health Service of Andalucía

    Málaga

Other trials in Spain

About this study

Official title: Effectiveness of a Diabetes Education Program Based on Tailored Interventions in the Andalusian Public Health and Social System (Edep-Ti Study).

GOALS:

PRIMARY:

  1. Analyze the overall impact of the proposed diabetes education program on metabolic control (HbA1c) and modifiable cardiovascular risk factors (lipid profile and blood pressure). SECONDARY:
  2. Evaluate the effectiveness of the program on smoking habits and body mass index (weight, height).
  3. Analyze the impact of the program on the quality of life related to health.
  4. Check the effect on lifestyles: compliance levels of physical exercise and adherence to diet mediterranean.

DESIGN: Cluster randomized controlled trial

Read the detailed description

The reference population will be patients with a diagnosis of diabetes mellitus in treatment with oral antidiabetics, excluding the insulinized patients. They will then be randomly assigned by cluster, to the intervention group (individual education) or control (usual care) in the context of each health center participating in the project. After randomization centers, all professionals who decide to cooperate receive a training process on methodology for measuring results (clinical and questionnaire variables), while assigned to the experimental intervention, will also receive training on how to carry out the program of diabetologic education proposed. The follow-up period for both groups is 18 months obtained as clinical determinations: glycosylated hemoglobin (metabolic control), blood pressure, lipid profile, smoking and BMI; and as results reported by the patient through questionnaires: quality of life related to health, level of physical activity performed or adherence to the Mediterranean diet.

Being tested
Therapeutic Education Program
Keywords
patient education, self-care, Controlled Trial
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Therapeutic Education ProgramBehavioural

    The total duration of the program will be 12 weeks with a maximum of 6 sessions of 30 minutes each. In the first session, through the EBADE questionnaire, the needs will be identified by grouping them by the 4 constructs of the theory of planned behavior (behavioral beliefs, subjective norm, behaviors of perceived control and behavioral intention). The interventions and the number of sessions will be adapted depending on the areas identified with barriers. These interventions will be applied in both face-to-face and telephone modalities, using the Nursing Intervention Classification and their respective activities. The interventions will be carried out by nurses who have previously received training on the proposed program. Follow-ups will be carried out every 15 days.

Study groups in NCT03453970
Study groupRoleWhat they receive
Therapeutic Education ProgramExperimentalThe program is based on adapted interventions and will consist of the following phases: Phase I: Identification of self-care needs in Diabetes Mellitus through the EBADE questionnaire. This instrument will identify the needs grouped by constructs of the theory of planned behavior (behavioral beliefs, subjective norm, behaviors of perceived control and behavioral intention). Phase II: Application of interventions adapted according to the behavioral mediator who encounters barriers. The interventions will be applied both in the face-to-face and telephone modality, using the Nursing Intervention Classification and their respective activities. Phase III: measurement of the clinical variables and reported by the patients described in the objectives.
Receives: Behavioral: Therapeutic Education Program
Usual CareNo interventionThe conventional intervention consists of the usual care that is followed in the nursing consultations in primary care to patients with type 2 DM, based on the recommendations of the Clinical Practice Guide of the National Health System

What is being measured

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

  1. Change from basal glycosylated hemoglobin (HbA1c) at 6 months, change from basal HbA1c at 12 months and change from basal HbA1c at 18 months

    Determination of HbA1c measured as a percentage

    Measured: 0,6,12 and18 months

  2. Lipidic profile: change from basal total cholesterol (TC) at 6 months, change from total basal cholesterol at 12 months and change from total basal cholesterol at 18 months.

    Determination of total cholesterol (TC) values measured in milligrams per deciliter (mg/dl).

    Measured: 0,6,12 and18 months

  3. Lipidic profile: change from baseline LDL cholesterol (LDLc) at 6 months, change from baseline LDLc at 12 months and change from baseline LDL cholesterol at 18 months.

    Determination of LDLc measured in milligrams per deciliter (mg/dl).

    Measured: 0,6,12 and18 months

  4. Lipidic profile:change from basal triglyceride (TG) levels at 6 months, change from basal TG levels at 12 months and change from baseline TG levels at 18 months.

    Determination of TG measured in milligrams per deciliter (mg/dl).

    Measured: 0,6,12 and18 months

  5. Change from baseline systolic blood pressure (SBP) at 6 months, change from baseline systolic blood pressure at 12 months and change from baseline systolic blood pressure at 18 months.

    Determination of systolic blood pressure measured in millimeters of mercury (mm / Hg), average of 2 determinations.

    Measured: 0,6,12 and18 months

  6. Change from baseline diastolic blood pressure (DBP) at 6 months, change from baseline diastolic blood pressure at 12 months and change from baseline diastolic blood pressure at 18 months.

    Determination of diastolic blood pressure measured in millimeters of mercury (mm / Hg), average of 2 determinations.

    Measured: 0,6,12 and18 months

Secondary outcomes (6)

  1. Development in smoking habits

    Number of cigarettes consumed per day on average (measured at 0,6,12 and 18 months)

    Measured: 0,6,12 and18 months

  2. Smoking rate

    Percentage of smokers of the total of the participants (measured at 0,6,12 and 18 months).

    Measured: 0,6,12 and18 months

  3. Change from baseline weight at 6 months, change from baseline weight at 12 months and change from baseline weight at 18 months.

    Determination of the body mass index calculated as the weight measured in kilograms (kg) divided by the height measured in meters squared (weight / height2) (Kg /m2) (measured at 0,6,12 and 18 months).

    Measured: 0,6,12 and18 months

  4. Change in the quality of life related to health (HRQoL) from the baseline determination at 6 months, change in the HRQoL from the baseline determination at 12 months and change in the HRQoL from the baseline determination at 18 months.

    The Diabetes Quality of Life Questionnaire EuroQol-5D (EQ-5D) in a Spanish version will be implemented at 0, 6, 12 and 18 months. With this questionnaire the individual himself assesses his health status, first in levels of severity (1-without problems, 2-some problems or moderate problems and 3-serious problems) by health dimensions (mobility, personal care, daily activities, pain/discomfort and anxiety / depression). The combination of the values of all dimensions generates 5-digit numbers, with 243 combinations of possible health states. A second part of the questionnaire includes a vertical analog visual scale ranging from 0 (worst imaginable health status) to 100 (best imaginable health status). In it, the individual must mark the point in the vertical line that best reflects his or her subjective assessment of their overall health status.

    Measured: 0,6,12 and18 months

  5. Change from the basal level of physical activity to 6 months, change from the basal level of physical activity to 12 months and change from the basal level of physical activity to 18 months.

    The International Physical Activity Questionnaire (IPAQ short version) will be implemented at 0, 6, 12 and 18 months. The IPAQ questionnaire in its short version is self-administered and consists of 7 questions that provide information on the time spent doing physical activities of moderate and vigorous intensity, separating time spent walking and time spent in a more passive state. Individuals can be classified into: low level of activity, moderate level (there are 3 criteria to classify a person as active) and high level of activity (there are 2 criteria to classify a person as very active).

    Measured: 0,6,12 and18 months

  6. Change from the baseline level of adherence to the diet at 6 months, change from the baseline level of adherence to the diet at 12 months and change from the baseline level of adherence to the diet at 18 months.

    The Questionnaire of Adherence to the Mediterranean Diet will be implemented at 0, 6, 12 and 18 months. It is a self-administered questionnaire consisting of 14 segments dedicated to eating habits. To estimate the results, the value 1 is assigned to each segment with an affirmative response and 0 to each segment with a non compliant response. From the sum of the values obtained, the degree of adherence is determined, establishing two levels, so that if the total score is greater than or equal to 9 it is considered a diet with a good level of adherence and if the total sum is lower of 9 the diet is considered to be of a low adherence.

    Measured: 0,6,12 and18 months

Timeline

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

  1. First posted5 Mar 2018
  2. Study start1 Dec 2018
  3. Primary completion1 Dec 2021
  4. Study completion31 Dec 2021

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03453970
Sponsor's protocol ID
AP-0005-2015 / PI14-01127
Acronym
Edep-Ti
Status last verified
Jul 2025
First submitted
17 Jan 2018
Last updated
29 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aguilar Diosdado M et al. II Plan Integral de Diabetes de Andalucía: 2009-2013. Sevilla: Consejería de Salud,2009

  • American Diabetes Association. Standars of Medical Care in Diabetes. Diabetes Care. 2015; 38(Suppl. 1):S1-2. DOI: 10.2337/dc15-S001

  • Andersson C, van Gaal L, Caterson ID, Weeke P, James WP, Coutinho W, Finer N, Sharma AM, Maggioni AP, Torp-Pedersen C. Relationship between HbA1c levels and risk of cardiovascular adverse outcomes and all-cause mortality in overweight and obese cardiovascular high-risk women and men with type 2 diabetes. Diabetologia. 2012 Sep;55(9):2348-55. doi: 10.1007/s00125-012-2584-3. Epub 2012 May 26.

    PubMed 22638548

  • Ajzen I. The theory of planned behavior. Organ. Behav. Hum. Decis. Process. 1991; 50(2):179-211.

  • Blackberry ID, Furler JS, Best JD, Chondros P, Vale M, Walker C, Dunning T, Segal L, Dunbar J, Audehm R, Liew D, Young D. Effectiveness of general practice based, practice nurse led telephone coaching on glycaemic control of type 2 diabetes: the Patient Engagement and Coaching for Health (PEACH) pragmatic cluster randomised controlled trial. BMJ. 2013 Sep 18;347:f5272. doi: 10.1136/bmj.f5272.

    PubMed 24048296

  • Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000 Sep 16;321(7262):694-6. doi: 10.1136/bmj.321.7262.694. No abstract available.

    PubMed 10987780

  • Carnethon MR, De Chavez PJ, Biggs ML, Lewis CE, Pankow JS, Bertoni AG, Golden SH, Liu K, Mukamal KJ, Campbell-Jenkins B, Dyer AR. Association of weight status with mortality in adults with incident diabetes. JAMA. 2012 Aug 8;308(6):581-90. doi: 10.1001/jama.2012.9282.

    PubMed 22871870

  • Cardenas-Valladolid J, Salinero-Fort MA, Gomez-Campelo P, de Burgos-Lunar C, Abanades-Herranz JC, Arnal-Selfa R, Andres AL. Effectiveness of standardized Nursing Care Plans in health outcomes in patients with type 2 Diabetes Mellitus: a two-year prospective follow-up study. PLoS One. 2012;7(8):e43870. doi: 10.1371/journal.pone.0043870. Epub 2012 Aug 27.

    PubMed 22952794

  • Caro-Bautista J, Martin-Santos FJ, Villa-Estrada F, Morilla-Herrera JC, Cuevas-Fernandez-Gallego M, Morales-Asencio JM. Using qualitative methods in developing an instrument to identify barriers to self-care among persons with type 2 diabetes mellitus. J Clin Nurs. 2015 Apr;24(7-8):1024-37. doi: 10.1111/jocn.12740. Epub 2014 Dec 19.

    PubMed 25523621

  • Caro-Bautista J, Martin-Santos FJ, Morales-Asencio JM. Systematic review of the psychometric properties and theoretical grounding of instruments evaluating self-care in people with type 2 diabetes mellitus. J Adv Nurs. 2014 Jun;70(6):1209-27. doi: 10.1111/jan.12298. Epub 2013 Nov 17.

    PubMed 24237156

  • Cassimatis M, Kavanagh DJ. Effects of type 2 diabetes behavioural telehealth interventions on glycaemic control and adherence: a systematic review. J Telemed Telecare. 2012 Dec;18(8):447-50. doi: 10.1258/jtt.2012.gth105. Epub 2012 Dec 3.

    PubMed 23209266

  • Claydon-Platt K, Manias E, Dunning T. The barriers and facilitators people with diabetes from a nonEnglish speaking background experience when managing their medications: a qualitative study. J Clin Nurs. 2014 Aug;23(15-16):2234-46. doi: 10.1111/jocn.12501. Epub 2013 Dec 26.

    PubMed 24372586

  • Deakin T, McShane CE, Cade JE, Williams RD. Group based training for self-management strategies in people with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003417. doi: 10.1002/14651858.CD003417.pub2.

    PubMed 15846663

  • Debussche X, Collin F, Fianu A, Balcou-Debussche M, Fouet-Rosiers I, Koleck M, Favier F. Structured self-management education maintained over two years in insufficiently controlled type 2 diabetes patients: the ERMIES randomised trial in Reunion Island. Cardiovasc Diabetol. 2012 Aug 2;11:91. doi: 10.1186/1475-2840-11-91.

    PubMed 22856504

  • Didarloo AR, Shojaeizadeh D, Gharaaghaji Asl R, Habibzadeh H, Niknami Sh, Pourali R. Prediction of Self-Management Behavior among Iranian Women with Type 2 Diabetes: Application of the Theory of Reasoned Action along with Self-Efficacy (ETRA). Iran Red Crescent Med J. 2012 Feb;14(2):86-95. Epub 2012 Feb 1.

    PubMed 22737561

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic Education Program in people with Diabetes Mellitus, Type 2, run by University of Malaga 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 1 inclusion and 7 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 29 Jul 2025. 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 from basal glycosylated hemoglobin (HbA1c) at 6 months, change from basal HbA1c at 12 months and change from basal HbA1c at 18 months (time frame: 0,6,12 and18 months). The study lists 6 primary outcomes in all. 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 NCT03453970, which also lists 46 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 29 Jul 2025; AzTrials last refreshed its copy on 29 Oct 2026.

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