Educational Intervention and Social Support in Diabetes Mellitus

Not Applicable

• Conditions: Diabetes Mellitus
• Interventions: Other: Educational intervention group for people with diabetes through Diabetes Conversation Maps; Other: Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact

• Registration Number: NCT01387633
• Lead Sponsor: University of Sao Paulo

Brief Summary

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

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.

Study Timeline

• Status Verified: 2010-02
• Study Start: 2011-06
• Primary Completion: 2011-06
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-07-01
• Last Update Submitted: 2011-07-01
• Study First Posted: 2011-07-04
• Last Update Posted: 2011-07-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational intervention group	Educational intervention group for people with diabetes through Diabetes Conversation Maps	Educational intervention group for people with diabetes through Diabetes Conversation Maps.
Educational intervention through telephone contact	Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact	Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact

Primary Outcome Measures

Name	Time	Method
glycated hemoglobin	21 mounths
fasting plasma glucose	21 mounths
triglycerides	21 mounths
total cholesterol and fractions	21 mounths
microalbuminuria	21 mounths
urea	21 mounths
creatinine	21 mounths
body mass index	21 mounths
waist circumference	21 mounths
blood pressure	21 mounths

Secondary Outcome Measures

Name	Time	Method
Perceived Self-Efficacy: Diabetes Management Self-efficacy Scale for Patients with Type 2 Diabetes Mellitus	21 mounths
Knowledge about diabetes mellitus: Diabetes Mellitus knowledge (DKN-A)	21 mounths
Adherence to medication treatment: Self-Reported Measure of Medication Adherence (Measure of Treatment Adherence - MTA)	21 mounths
Adherence to self care: Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) ( Diabetes Self-Care Activities Questionnaire)	21 mounths
Perception of stress: Perceived Stress Scale (Perceived Stress Scale)	21 mounths
Ways of coping: Ways of Coping Scale (Ways of Coping Scale)	21 mounths
Acceptance of Illness (Acceptance of Illness Scale)	21 mounths
Perception of social support: The Social Support Network Inventory	21 mounths
Self-monitoring of blood glucose	21 mounths

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo; 🇧🇷 Ribeirão Preto, São Paulo, Brazil