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Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home

NCT ID: NCT01475422

Last Updated: 2011-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conversation Maps Diabetes Education

Group Type EXPERIMENTAL

Conversation Maps Diabetes Education

Intervention Type 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.

Usual Care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Vívian Saraiva Veras

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of São Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Vívian Saraiva Veras, Principal Investigator

Role: CONTACT

Phone: 55 16 88074113

Email: [email protected]

Facility Contacts

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Vívian Saraiva Veras, Principal Investigator

Role: primary

Other Identifiers

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6266936

Identifier Type: -

Identifier Source: org_study_id