Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home

NCT01475422 | Unknown DMC

• 1 other identifier: 6266936
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Change from baseline in HbA1c at 6 months to less than 7%

  baseline, 3 and 6 months post intervention

Secondary Outcomes (2)

• Diabetes Knowledge Questionnaire - DKN-A

  baseline, 3 and 6 months post intervention

• Diabetes Attitude Questionnaire - ATT-19

  baseline, 3 and 6 months post intervention

Study Arms (2)

Conversation Maps Diabetes Education

EXPERIMENTAL

Behavioral: Conversation Maps Diabetes Education

Usual Care

ACTIVE COMPARATOR

Behavioral: Usual Care

Interventions

Conversation Maps Diabetes Education BEHAVIORAL

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.

Conversation Maps Diabetes Education

Usual Care BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo

Ribeirão Preto, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Vívian Saraiva Veras, Principal Investigator

CONTACT

55 16 88074113; vivianveras@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 21, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: November 21, 2011

Record last verified: 2011-11

Locations

BR (1)