Educational Intervention and Social Support in Diabetes Mellitus

NCT01387633 | Unknown DMC

• 1 other identifier: diabetes2011
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Nursing care; Diabetes mellitus; Health Education; Patient compliance; Social support; Self-efficacy; Adaptation strategy

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (9)

• 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

Study Arms (2)

Educational intervention through telephone contact

EXPERIMENTAL

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

Educational intervention group

ACTIVE COMPARATOR

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

Other: Educational intervention group for people with diabetes through Diabetes Conversation Maps

Interventions

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

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 through telephone contact

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

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.

Educational intervention group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Ribeirão Preto, São Paulo, 14048-900, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Health Education; Patient Compliance

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adherence Interventions; Medication Adherence; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Ana Emilia Pace, Principal Investigator

CONTACT

(55) 16 3603-3401; aepace@eerp.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: July 4, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2011
• Last Updated: July 4, 2011

Record last verified: 2010-02

Locations

BR (1)