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临床试验/NCT01387633
NCT01387633Unknown不适用

Educational Intervention and Social Support in Diabetes Mellitus

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2011年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
264
试验地点
1
主要终点
glycated hemoglobin

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

  • •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

研究组 & 干预措施

Educational intervention through telephone contact

Experimental

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

干预措施: Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact (Other)

Educational intervention group

Active Comparator

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

干预措施: Educational intervention group for people with diabetes through Diabetes Conversation Maps (Other)

结局指标

主要结局

glycated hemoglobin

时间窗: 21 mounths

fasting plasma glucose

时间窗: 21 mounths

triglycerides

时间窗: 21 mounths

total cholesterol and fractions

时间窗: 21 mounths

microalbuminuria

时间窗: 21 mounths

urea

时间窗: 21 mounths

creatinine

时间窗: 21 mounths

body mass index

时间窗: 21 mounths

waist circumference

时间窗: 21 mounths

blood pressure

时间窗: 21 mounths

次要结局

  • 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)

研究者

申办方类型
Other

研究点 (1)

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