Impact of a Program of Non-pharmacological Intervention in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT02456064

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-01-31

Brief Summary

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The purpose of this study is to determine whether a non-drug intensive program can help improve control of type 2 diabetes mellitus.

Detailed Description

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This study is based on the creation of two groups of patients with type 2 diabetes mellitus over a period of six months .

In one of the groups an intensive program be developed through : group medical consultations , workshops , informative talks, " expert patient " telephone inquiries .. etc. Meanwhile , the control group that will be followed in the consultations as usual.

We will make a determination of HbA1c at 3 months and 6 months later to assess whether there are significant differences between the two groups .

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lifestyle counseling

In this group we will make an intensive program based on: workshops, educational talks, group medical practices and "expert patient" among others conduct auditions.

Group Type EXPERIMENTAL

Lifestyle counseling

Intervention Type BEHAVIORAL

* Group medical visits
* Telephone medical consultations
* Expert patient
* Training workshops

Normal group

In this group will be controlled as usual in the consultations.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle counseling

* Group medical visits
* Telephone medical consultations
* Expert patient
* Training workshops

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients with type 2 diabetes mellitus with poor control of their disease.
* No changes have been made in pharmacological previous 3 months.

Exclusion Criteria

* Changes in their drug treatment in the past 3 months.
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Equipo Multidisciplinar Sanitario CS Foietes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ivan S Silvera

Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

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Equipo Multidisciplinar

Identifier Type: -

Identifier Source: org_study_id

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