Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Vívian Saraiva Veras, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01475422
First received: November 10, 2011
Last updated: November 16, 2011
Last verified: November 2011
  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 Blind (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 University of Sao Paulo:

Primary Outcome Measures:
  • HbA1c [ Time Frame: baseline, 3 and 6 months post intervention ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Change from baseline in DKN-A at six months

  • Diabetes Attitude Questionnaire - ATT-19 [ Time Frame: baseline, 3 and 6 months post intervention ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Vívian Saraiva Veras, PhD Student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01475422     History of Changes
Other Study ID Numbers: 6266936
Study First Received: November 10, 2011
Last Updated: November 16, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on October 21, 2014