Educational Intervention and Social Support in Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01387633
• Other study ID #: diabetes2011
• Status: Unknown status
• Phase: N/A
• First received: June 16, 2011
• Last updated: July 1, 2011
• Start date: June 2011

Study information

• Verified date: February 2010
• Source: University of Sao Paulo
• Contact: Ana Emilia Pace, Principal Investigator
• Phone: (55) 16 3603-3401
• Email: aepace[@]eerp.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 264
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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
• 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.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycated hemoglobin		21 mounths
Primary	fasting plasma glucose		21 mounths
Primary	triglycerides		21 mounths
Primary	total cholesterol and fractions		21 mounths
Primary	microalbuminuria		21 mounths
Primary	urea		21 mounths
Primary	creatinine		21 mounths
Primary	body mass index		21 mounths
Primary	waist circumference		21 mounths
Primary	blood pressure		21 mounths
Secondary	Perceived Self-Efficacy: Diabetes Management Self-efficacy Scale for Patients with Type 2 Diabetes Mellitus		21 mounths
Secondary	Knowledge about diabetes mellitus: Diabetes Mellitus knowledge (DKN-A)		21 mounths
Secondary	Adherence to medication treatment: Self-Reported Measure of Medication Adherence (Measure of Treatment Adherence - MTA)		21 mounths
Secondary	Adherence to self care: Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) ( Diabetes Self-Care Activities Questionnaire)		21 mounths
Secondary	Perception of stress: Perceived Stress Scale (Perceived Stress Scale)		21 mounths
Secondary	Ways of coping: Ways of Coping Scale (Ways of Coping Scale)		21 mounths
Secondary	Acceptance of Illness (Acceptance of Illness Scale)		21 mounths
Secondary	Perception of social support: The Social Support Network Inventory		21 mounths
Secondary	Self-monitoring of blood glucose		21 mounths