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Type 2 Diabetes MellitusNCT02663245

INTEGRA Study: Primary Care Intervention in Type 2 Diabetes Patients With Poor Glycaemic Control

A study testing Intervention 1 and Intervention 2 in people with Type 2 Diabetes Mellitus, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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

The intensification of the management for the control of glycaemia and other risk factors in patients with type 2 diabetes (DM2) results in a reduction of diabetes-related complications. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Intervention 1 and Intervention 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
564 participants
Where
1 siteSpain
Study dates
Dec 2015to 31 Dec 2018
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 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Type 2 DM according to criteria of the World Health Organisation of one or more years of disease duration.
  • Age from 30 to 80 years.
  • HbA1C ≥ 9% (DCCT) according to the last blood test carried out during the 12 months prior to inclusion in the study
  • No changes in the treatment that can influence the main variable during the 3 months prior inclusion in the study.
  • Accepting to participate in the study and signing of the informed consent form.

Who cannot join

  • Patient refuses to participate and any other condition that prevents signing the informed consent form.
  • Other types of diabetes: Type 1 DM, gestational diabetes and diabetes secondary to other diseases.
  • Pharmacological treatments that interfere with carbohydrate metabolism, such as steroids.
  • Life expectancy under 2 years.
  • Current treatment for cancer other than basocellular or epidermoid skin cancer.
  • Severe mental disease and dementia.
Show all 18Show fewer
  • Heart failure Class III or IV (NYHA).
  • Renal transplant or current treatment with dialysis.
  • Alcohol and drug abuse.
  • Pregnancy or intention to get pregnant.
  • Breastfeeding.
  • Chronic treatment with steroids; treatment with steroids during the 2 months prior inclusion in the study.
  • Pharmacological treatment for weight loss during the 2 months prior to inclusion in the - study.
  • Treatment with immunosuppressants.
  • Haemoglobinopathies and chronic anaemia.
  • Body Mass Index > 45 mg/kg2 (1)
  • Participation in clinical trials for medicines.
  • Patients with conditions that prevent follow up and completion of protocol.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Laura Montero

    Tàrrega, LLeida, 25300

Other trials in Spain

About this study

Official title: INTEGRA Study: Intervention in Type 2 Diabetes Mellitus Patients With Poor Glycemic Control on Primary Health Care.

The intensification of the management for the control of glycaemia and other risk factors in patients with type 2 diabetes (DM2) results in a reduction of diabetes-related complications.

The strategy to increase the competences of primary care professionals to improve health care has been mainly prompted by the current context of limited resources and restricted access to specialty care.

Read more

This study aims to evaluate the effectiveness and cost-effectiveness of an integral intervention carried out by primary care professionals with the following components:

  1. detection of patients with poor diabetic control;
  2. introduction of a specific consultation on diabetes followed by virtual and telephone specialist support;
  3. introduction of other measures to overcome patients and professionals barriers to treatment.

The main objective of the study is to determine if glycaemic control as measured by the mean concentration of HbA1c of poorly controlled patients improves when these patients are evaluated and treated in primary care under the integral strategy proposed in this study. The INTEGRA project also includes Phase 1 (qualitative research study), which is aimed at identifying viable strategies to suppress barriers to treatment; these strategies have been included to the intervention study (phase 2).

Phase 2 is a controlled, quasi-experimental intervention that involves 9 primary care centres of 3 regions (Lleida, Girona, Barcelona). The participants are patients with DM2 with poor glycaemic control that meet all the inclusion criteria and sign the informed consent. The intervention study will have three arms: (1) Control Group; (2) Intervention Group 1 (diabetes specific consultation + additional measures originated in phase 1; and (3) Intervention Group 2 (additional measures originated in phase 1).

Phase 1 has been conducted during the last 6 months previous to the initiation of the proposed intervention study and consisted of a qualitative design (individualized interviews with randomly selected patients in each of the participating centers); this qualitative study has contributed to design the final intervention applied on phase 2, particularly, implementing additional measures as coaching sessions to health professionals of the participating centers and automated messaging to patients with reminder and motivational objectives.

Phase 2 consists of a recruitment period of 6 months, followed by a 12-month follow-up for each patient

Being tested
Intervention 1, Intervention 2
Keywords
Type 2 diabetes mellitus, glycemic control
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.

  • Intervention 1Other

    • Diabetes specific consultation
    • Basic training in clinical guidelines
    • Platform of communication for professionals
    • Training update to review and evaluate actual cases where the coaching strategy has been applied 2-hours training programme to update and review the training of month 0.
    • 7-hour training programme in group coaching for primary care professionals with a theoretical and practical approach.
    • Intervention based on text messaging to patients to remind them of strategies that promote behaviour change in relation to diabetes.

  • Intervention 2Other

    • 7-hour training programme in group coaching for primary care professionals with a theoretical and practical approach.
    • Training update to review and evaluate actual cases where the coaching strategy has been applied 2-hour training programme to update and review the training of month 0.
    • Basic training in clinical guidelines.
    • Platform of communication for professionals.
    • Intervention based on text messaging to patients to remind them of strategies that promote behaviour change in relation to diabetes.
Study groups in NCT02663245
Study groupRoleWhat they receive
Intervention 1ExperimentalDiabetes specific consultation + multicomponent intervention aimed at professionals and patients
Receives: Other: Intervention 1
Intervention 2ExperimentalMulticomponent intervention aimed at professionals and patients minus the diabetes specific consultation.
Receives: Other: Intervention 2
Control groupNo interventionNo intervention. Data of the control groups will be retrieved from the SIDIAP.

What is being measured

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

  1. Glycaemic control measured by HbA1c

    Measured: 12 months

Secondary outcomes (8)

  1. lipid profile control as measured by the mean concentration of LDL-cholesterol, non-HDL cholesterol and triglycerides

    Measured: 12 months

  2. measurement of systolic blood pressure and of diastolic blood pressure

    Measured: 12 months

  3. control of chronic complications associated with type 2 diabetes according to the protocol of the CIH

    Measured: 12 months

  4. direct health costs of type 2 diabetic patients

    Measured: 12 months

  5. evaluation of patient satisfaction using spanish version of diabetes treatment satisfaction questionnaire (DTSQ)

    Measured: 12 months

  6. control of risk factors, smoking and exercise: Patient Activation Measure questionnaire

    Measured: 12 months

  7. evaluation of therapeutic inertia: specific questionnaire created by Redgedaps

    Measured: 12 months

  8. evaluation of quality of life using spanish version of diabetes quality of life questionnaire (EsDQOL)

    Measured: 12 months

Timeline

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

  1. First posted26 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completion31 Oct 2018
  4. Study completion31 Dec 2018

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
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
564 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02663245
Sponsor's protocol ID
P14/129
Status last verified
Feb 2019
First submitted
4 Dec 2015
Last updated
15 Feb 2019
Results posted
No
Data monitoring committee
No

Publications

  • Mollo A, Vlacho B, Gratacos M, Mata-Cases M, Rubinat E, Berenguera Osso A, Cos FX, Franch-Nadal J, Khunti K, Mauricio D; INTEGRA research group. A multicomponent health care intervention is associated with improved glycaemic control in subjects with poorly controlled type 2 diabetes compared with routine care: The INTEGRA study. Diabetes Obes Metab. 2023 Dec;25(12):3549-3559. doi: 10.1111/dom.15250. Epub 2023 Aug 22.

    PubMed 37608473

  • Mollo A, Berenguera A, Rubinat E, Vlacho B, Mata M, Franch J, Bolibar B, Mauricio D. INTEGRA study protocol: primary care intervention in type 2 diabetes patients with poor glycaemic control. BMC Fam Pract. 2019 Feb 7;20(1):25. doi: 10.1186/s12875-019-0916-9.

    PubMed 30732583

Questions about this trial

What is this clinical trial studying?

A study testing Intervention 1 and Intervention 2 in people with Type 2 Diabetes Mellitus, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina 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 5 inclusion and 18 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 15 Feb 2019. 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?

Glycaemic control measured by HbA1c (time frame: 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 NCT02663245, which also lists 2 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 15 Feb 2019.

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Clinical Trial NCT02663245 | AzTrials