Clinical trial NCT01387633: Educational Intervention and Social Support in Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Nursing care
Diabetes mellitus
Health Education
Patient compliance
Social support
Self-efficacy
Adaptation strategy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-07-04
Enrollment: 264
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

Primary outcomes:
measure: glycated hemoglobin
timeFrame: 21 mounths
measure: fasting plasma glucose
timeFrame: 21 mounths
measure: triglycerides
timeFrame: 21 mounths
measure: total cholesterol and fractions
timeFrame: 21 mounths
measure: microalbuminuria
timeFrame: 21 mounths
measure: urea
timeFrame: 21 mounths
measure: creatinine
timeFrame: 21 mounths
measure: body mass index
timeFrame: 21 mounths
measure: waist circumference
timeFrame: 21 mounths
measure: blood pressure
timeFrame: 21 mounths
Secondary outcomes:
measure: Perceived Self-Efficacy: Diabetes Management Self-efficacy Scale for Patients with Type 2 Diabetes Mellitus
timeFrame: 21 mounths
measure: Knowledge about diabetes mellitus: Diabetes Mellitus knowledge (DKN-A)
timeFrame: 21 mounths
measure: Adherence to medication treatment: Self-Reported Measure of Medication Adherence (Measure of Treatment Adherence - MTA)
timeFrame: 21 mounths
measure: Adherence to self care: Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) ( Diabetes Self-Care Activities Questionnaire)
timeFrame: 21 mounths
measure: Perception of stress: Perceived Stress Scale (Perceived Stress Scale)
timeFrame: 21 mounths
measure: Ways of coping: Ways of Coping Scale (Ways of Coping Scale)
timeFrame: 21 mounths
measure: Acceptance of Illness (Acceptance of Illness Scale)
timeFrame: 21 mounths
measure: Perception of social support: The Social Support Network Inventory
timeFrame: 21 mounths
measure: Self-monitoring of blood glucose
timeFrame: 21 mounths
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
state: São Paulo
Study officials:
References: