Educational Intervention and Social Support in Diabetes Mellitus

NCT ID: NCT01387633

Last Updated: 2011-07-04

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

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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The purpose of this study is to evaluate the impact of an educational program for people with diabetes mellitus based on the family social support.

Detailed Description

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H0: The person with diabetes who participates in the educational group whose family member/caregiver receives educational interventions hasn't greater glycemic control.

HA: The person with diabetes who participates in the educational group whose family member/caregiver receives educational interventions has greater glycemic control.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Educational intervention through telephone contact

Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact

Group Type EXPERIMENTAL

Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact

Intervention Type OTHER

For family members/caregivers: telephone contacts will be conducted in day and time which family member/caregiver prefers, and he/she may make collect calls to the researcher always he/she judges it necessary during the period of study. Phone contacts will be recorded to ensure the registration of orientation given, using a digital phone recorder PCTEL. And they will be arranged with the technique of motivational interviewing that includes the skills to ask, listen and inform. For this, protocols based on these skills, which the covered topics will be those worked in group sessions through Diabetes Conversation Maps. Voice quality related to the tone, volume and clarity as well as the skills and strategies to listen to the interviews will be worked under the guidance of an audiologist

Educational intervention group

Educational intervention group for people with diabetes through Diabetes Conversation Maps.

Group Type ACTIVE_COMPARATOR

Educational intervention group for people with diabetes through Diabetes Conversation Maps

Intervention Type OTHER

For people with diabetes mellitus: educational interventions will be conducted in accordance with the assumptions of the Social Cognitive Theory, through Diabetes Conversation Maps , whose use is consistent with this theory (ADA, 2007). Diabetes Conversation Maps are a tool which involves people in the learning process about the disease, to make them able to process information more effectively and use them in making daily decisions in the management of diabetes mellitus (DM). It is recommended that this tool is used in small groups of three to ten people, in order to provide dynamic discussions among the participants (ADA, 2007). Currently, the maps that cover the following learning contexts: How the Body and Diabetes Work, Healthy Eating and Physical Activity, and Medication Treatment and Monitoring of Blood Glucose; Achieving the Goals with the Insulin and Weather Map of Diabetic Foot are available for the Brazilian Portuguese language.

Interventions

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Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact

For family members/caregivers: telephone contacts will be conducted in day and time which family member/caregiver prefers, and he/she may make collect calls to the researcher always he/she judges it necessary during the period of study. Phone contacts will be recorded to ensure the registration of orientation given, using a digital phone recorder PCTEL. And they will be arranged with the technique of motivational interviewing that includes the skills to ask, listen and inform. For this, protocols based on these skills, which the covered topics will be those worked in group sessions through Diabetes Conversation Maps. Voice quality related to the tone, volume and clarity as well as the skills and strategies to listen to the interviews will be worked under the guidance of an audiologist

Intervention Type OTHER

Educational intervention group for people with diabetes through Diabetes Conversation Maps

For people with diabetes mellitus: educational interventions will be conducted in accordance with the assumptions of the Social Cognitive Theory, through Diabetes Conversation Maps , whose use is consistent with this theory (ADA, 2007). Diabetes Conversation Maps are a tool which involves people in the learning process about the disease, to make them able to process information more effectively and use them in making daily decisions in the management of diabetes mellitus (DM). It is recommended that this tool is used in small groups of three to ten people, in order to provide dynamic discussions among the participants (ADA, 2007). Currently, the maps that cover the following learning contexts: How the Body and Diabetes Work, Healthy Eating and Physical Activity, and Medication Treatment and Monitoring of Blood Glucose; Achieving the Goals with the Insulin and Weather Map of Diabetic Foot are available for the Brazilian Portuguese language.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* People with DM2
* Both sexes
* Minimum age of 40 years
* Able to dialogue
* Lack of complications in advanced

Exclusion Criteria

* Hemodialysis treatment
* Amaurosis
* Sequelae of Stroke and/or Heart Failure
* Previous amputations at any level of the lower limb
* Active ulcer in the lower limbs
* People in wheelchairs and/or litter
* People with limited understanding of the instruments due to cultural factors
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 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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University of Sao Paulo at Ribeirão Preto College of Nursing

Locations

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Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Ana Emilia Pace, Principal Investigator

Role: CONTACT

(55) 16 3603-3401

Facility Contacts

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Ana Emilia Pace, Principal Investigator

Role: primary

(55) 16 3602-3401

Other Identifiers

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diabetes2011

Identifier Type: -

Identifier Source: org_study_id

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