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Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Vívian Saraiva Veras, University of Sao Paulo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01475422
First Posted: November 21, 2011
Last Update Posted: November 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vívian Saraiva Veras, University of Sao Paulo
  Purpose
The self-monitoring of capillary blood glucose is part of the package of interventions in diabetes mellitus and an effective therapeutic strategy for the adequate control of the disease; and the continuing education of people with DM is recognized as one of the goals to delay the complications arising from chronic disease and alleviate the symptoms of hypoglycemia and hyperglycemia.

Condition Intervention
Diabetes Mellitus Behavioral: Conversation Maps Diabetes Education Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home in Metabolic Control of People With Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Vívian Saraiva Veras, University of Sao Paulo:

Primary Outcome Measures:
  • HbA1c [ Time Frame: baseline, 3 and 6 months post intervention ]
    Change from baseline in HbA1c at 6 months to less than 7%


Secondary Outcome Measures:
  • Diabetes Knowledge Questionnaire - DKN-A [ Time Frame: baseline, 3 and 6 months post intervention ]
    Change from baseline in DKN-A at six months

  • Diabetes Attitude Questionnaire - ATT-19 [ Time Frame: baseline, 3 and 6 months post intervention ]
    Change from baseline in ATT-19 at six months


Estimated Enrollment: 91
Study Start Date: September 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conversation Maps Diabetes Education Behavioral: Conversation Maps Diabetes Education
The Conversation Maps program is a set of innovative, interactive diabetes education tools developed by the Healthy Interactions, and endorsed by the American Diabetes Association. It consists of four conversation maps covering: 1) how the body and diabetes works, 2) healthy eating and physical activity, 3) treatment with medication and monitoring blood glucose, and 4) reaching the targets with insulin (a fifth map covering gestational diabetes will not be used in this study), and a program manual to help educators successfully implement the program. Participants will be followed for an expected average of 12 weeks.
Active Comparator: Usual Care Behavioral: Usual Care
Patients are followed in the medical appointments for evaluation and treatment of diabetes mellitus, according to service routine. Participants will be followed for an expected average of 12 weeks.

Detailed Description:
This study aims to evaluate the effects of educational intervention on self-monitoring of capillary blood glucose in metabolic control, knowledge and attitude in two groups of patients with diabetes mellitus: a group of diabetic patients who participate in the Self-Monitoring of Capillary Blood Glucose at Home Program and receive educational interventions (Intervention Group - G1) and a group of diabetic patients who participle in the Self-Monitoring of Capillary Blood Glucose at Home Program and receive conventional treatment (Control Group - G2). As an educational tool in diabetes will be used Conversation Maps which is considered an interactive program of diabetes education.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 18 Years and older;
  • Diagnosis of type 1 and 2 diabetes mellitus;
  • In follow-up in the Self-Monitoring of Capillary Blood Glucose at Home Program;
  • Have cognitive conditions that enable participation (minimum ability of users to understand issues of data collection instruments, observation of the researcher and/or of the caregivers).

Exclusion Criteria:

  • Patients with gestational DM;
  • Patients with DM who are not located;
  • Those who die in the proposed period for the research;
  • Those who dropout the Self-Monitoring of Capillary Blood Glucose at Home Program;
  • Those who report difficulties to participate of the study due to work and those with amaurosis;
  • Used Conversation Maps as an educational tool.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475422


Contacts
Contact: Vívian Saraiva Veras, Principal Investigator 55 16 88074113 vivianveras@hotmail.com

Locations
Brazil
University of São Paulo Recruiting
Ribeirão Preto, São Paulo, Brazil
Contact: Vívian Saraiva Veras, Principal Investigator    55 16 88074113    vivianveras@hotmail.com   
Principal Investigator: Vívian Saraiva Veras         
Sub-Investigator: Maria Lúcia Zanetti, Study Chair         
Sponsors and Collaborators
University of Sao Paulo
  More Information

Responsible Party: Vívian Saraiva Veras, PhD Student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01475422     History of Changes
Other Study ID Numbers: 6266936
First Submitted: November 10, 2011
First Posted: November 21, 2011
Last Update Posted: November 21, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases