Educational Intervention and Social Support in Diabetes Mellitus

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14048-900
      • Recruiting
      • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
      • Contact: Ana Emilia Pace, Principal Investigator; Phone Number: (55) 16 3602-3401; Email: aepace@eerp.usp.br
      • Principal Investigator: Ana Emilia Pace, Principal Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational intervention through telephone contact; Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact	Other: 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
Active Comparator: Educational intervention group; Educational intervention group for people with diabetes through Diabetes Conversation Maps.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: July 1, 2011
• First Posted (Estimate): July 4, 2011

Study Record Updates

• Last Update Posted (Estimate): July 4, 2011
• Last Update Submitted That Met QC Criteria: July 1, 2011
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Diabetes mellitus; Health Education; Self-efficacy; Nursing care; Social support; Patient compliance; Adaptation strategy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: diabetes2011