Educational Intervention and Social Support in Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01387633
First received: June 16, 2011
Last updated: July 1, 2011
Last verified: February 2010
  Purpose

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.


Condition Intervention
Diabetes Mellitus
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • glycated hemoglobin [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • fasting plasma glucose [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • triglycerides [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • total cholesterol and fractions [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • microalbuminuria [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • urea [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • creatinine [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • body mass index [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • waist circumference [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • blood pressure [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Perceived Self-Efficacy: Diabetes Management Self-efficacy Scale for Patients with Type 2 Diabetes Mellitus [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • Knowledge about diabetes mellitus: Diabetes Mellitus knowledge (DKN-A) [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • Adherence to medication treatment: Self-Reported Measure of Medication Adherence (Measure of Treatment Adherence - MTA) [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • Adherence to self care: Summary of Diabetes Self-Care Activities Questionnaire (SDSCA) ( Diabetes Self-Care Activities Questionnaire) [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • Perception of stress: Perceived Stress Scale (Perceived Stress Scale) [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • Ways of coping: Ways of Coping Scale (Ways of Coping Scale) [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • Acceptance of Illness (Acceptance of Illness Scale) [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • Perception of social support: The Social Support Network Inventory [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]
  • Self-monitoring of blood glucose [ Time Frame: 21 mounths ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 264
Study Start Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01387633

Contacts
Contact: Ana Emilia Pace, Principal Investigator (55) 16 3603-3401 aepace@eerp.usp.br

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo Recruiting
Ribeirão Preto, São Paulo, Brazil, 14048-900
Contact: Ana Emilia Pace, Principal Investigator    (55) 16 3602-3401    aepace@eerp.usp.br   
Principal Investigator: Ana Emilia Pace, Principal Investigator         
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided

Responsible Party: University of São Paulo, University of Sao Paulo at Ribeirão Preto College of Nursing
ClinicalTrials.gov Identifier: NCT01387633     History of Changes
Other Study ID Numbers: diabetes2011
Study First Received: June 16, 2011
Last Updated: July 1, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Nursing care
Diabetes mellitus
Health Education
Patient compliance
Social support
Self-efficacy
Adaptation strategy

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 10, 2014