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

March 25, 2017 updated by: Equipo Multidisciplinar Sanitario CS Foietes

Impact of a Program of Non-pharmacological Intervention in Patients With Type 2 Diabetes Mellitus With Poor Control of Their Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 .

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Lifestyle counseling
  • Group medical visits
  • Telephone medical consultations
  • Expert patient
  • Training workshops
No Intervention: Normal group
In this group will be controlled as usual in the consultations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Equipo Multidisciplinar Sanitario CS Foietes

Investigators

  • Principal Investigator: Ivan S Silvera

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 24, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 25, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Equipo Multidisciplinar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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