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

November 10, 2011
November 16, 2011
September 2011
December 2011   (final data collection date for primary outcome measure)
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%
Same as current
Complete list of historical versions of study NCT01475422 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home
Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home in Metabolic Control of People With Diabetes Mellitus

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Diabetes Mellitus
  • 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.
  • 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.
  • Experimental: Conversation Maps Diabetes Education
    Intervention: Behavioral: Conversation Maps Diabetes Education
  • Active Comparator: Usual Care
    Intervention: Behavioral: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
91
March 2012
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact: Vívian Saraiva Veras, Principal Investigator 55 16 88074113 vivianveras@hotmail.com
Brazil
 
NCT01475422
6266936
Yes
Vívian Saraiva Veras, University of Sao Paulo
University of Sao Paulo
Not Provided
Not Provided
University of Sao Paulo
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP