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Clinical Trials/NCT01387633
NCT01387633
Unknown
N/A

Educational Intervention and Social Support in Diabetes Mellitus

University of Sao Paulo1 site in 1 country264 target enrollmentJune 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
University of Sao Paulo
Enrollment
264
Locations
1
Primary Endpoint
glycated hemoglobin
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
June 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

glycated hemoglobin

Time Frame: 21 mounths

fasting plasma glucose

Time Frame: 21 mounths

triglycerides

Time Frame: 21 mounths

total cholesterol and fractions

Time Frame: 21 mounths

microalbuminuria

Time Frame: 21 mounths

urea

Time Frame: 21 mounths

creatinine

Time Frame: 21 mounths

body mass index

Time Frame: 21 mounths

waist circumference

Time Frame: 21 mounths

blood pressure

Time Frame: 21 mounths

Secondary Outcomes

  • 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)

Study Sites (1)

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