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Educational Intervention and Social Support in Diabetes Mellitus

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01387633
Enrollment
264
Registered
2011-07-04
Start date
2011-06-30
Completion date
Unknown
Last updated
2011-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

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

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.

Interventions

OTHEREducational 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

OTHEREducational 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.

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
blood pressure21 mounths
glycated hemoglobin21 mounths
fasting plasma glucose21 mounths
triglycerides21 mounths
total cholesterol and fractions21 mounths
microalbuminuria21 mounths
urea21 mounths
creatinine21 mounths
body mass index21 mounths
waist circumference21 mounths

Secondary

MeasureTime frame
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 Inventory21 mounths
Self-monitoring of blood glucose21 mounths
Perceived Self-Efficacy: Diabetes Management Self-efficacy Scale for Patients with Type 2 Diabetes Mellitus21 mounths

Countries

Brazil

Contacts

Primary ContactAna Emilia Pace, Principal Investigator
aepace@eerp.usp.br(55) 16 3603-3401

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026