Effectiveness of Self-care Rests on Knowledge, Self-care and Cardiometabolic Control of Adult Men With Diabetes Mellitus

NCT02974413 | Unknown

• 1 other identifier: State University of Maringá
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This research project has the main objective to analyze the benefits of self-care supported for adult men with Diabetes Mellitus. Treat yourself will randomized-controlled clinical study, randomized cluster to be developed with men aged between 40 and 70 years who have type 2 diabetes and are registered with the Health Strategy teams of the Municipality of Family Maringa. The recruited subjects will be randomly allocated into two groups: intervention group and control group. In the first, individuals will participate in a self-care intervention supported by a nurse, based on supported self-care and behavior change protocol; and second, individuals participate in conversation circles and will have the assistance normally provided by health services. The follow-up will take place for six months and will be collected information: socioeconomic, demographic, behavioral health, complications, laboratory and anthropometric. It is intended, through this study, demonstrate the effectiveness of this type of intervention, user-centric, on the health of men with DM, reinforcing this option of choice for professionals and users within the Primary Health Care (PHC).

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  Change in glycemic control between baseline and six months: should be determined by the values of glycated hemoglobin, which will be compared between the two moments (baseline and six months).

  Baseline and six months

Secondary Outcomes (7)

• Self-care attitudes

  Baseline and six months

• Self-efficacy (or Empowerment)

  Baseline and six months

• Psychological adjustment

  Baseline and six months

• Knowledge about diabetes

  Baseline and six months

• Clinical indicators of cardiometabolic control

  Baseline and six months

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention to be performed will be based on the principles and steps of supported self-care, guided by Behavior Change Protocol (Behavior Change Protocol - BCP) and consists of an educational program with quarterly meetings, and individual at home, through home visits, and group in the Basic Health Unit (BHU), in addition to telephone monitoring in the interval between two meetings. This intervention will be applied together adult men with type 2 diabetes who are randomized in the intervention group (IG) for six months. Thus, these men will take part in three meetings, individual or group, and will receive four telephone calls in between the face meetings. Our objective is to draw with this intervention by the participant, an individual plan of self-care, based on concretras goals and supports you in the implementation of this plan, in order to improve their self-efficacy in self-care and therefore glycemic control.

Behavioral: self-care supported

Control

NO INTERVENTION

The study will also include a Control Group (CG), and the participants of this group will participate in conversation circles at the beginning and the end of the six month follow-up.

Interventions

self-care supported BEHAVIORAL

The intervention to be performed will be based on the principles and steps of supported self-care, guided by Behavior Change Protocol (Behavior Change Protocol - BCP) and consists of an educational program with quarterly meetings, and individual at home, through home visits, and group in the Basic Health Unit (BHU), in addition to telephone monitoring in the interval between two meetings. This intervention will be applied together adult men with type 2 diabetes who are randomized in the intervention group (IG) for six months. Thus, these men will take part in three meetings, individual or group, and will receive four telephone calls in between the face meetings. Our objective is to draw with this intervention by the participant, an individual plan of self-care, based on concretras goals and supports you in the implementation of this plan, in order to improve their self-efficacy in self-care and therefore glycemic control.The study will also include a Control Group (CG).

Intervention

Eligibility Criteria

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

You may qualify if:

• Having medical diagnosis of DM2;
• Being male;
• Age between 20 and 59 years;
• Is domiciled in the city of Maringa in the FHS coverage area; Being part of the ESF families register.
• Being able to answer the questions of data collection instruments;
• Relate visual ability , hearing and locomotor to perform self-care;
• Have telephone contact (mobile or fixed) for monitoring the program.

You may not qualify if:

• Present lesions in target organs (brain, heart, kidneys, eyes) or comorbidities/complications resulting from diabetes, recorded in medical records, such as chronic renal failure;
• Have psychological or other disorders , registered in the medical records, and that compromise the understanding of the study, who do not agree or do not have availability to participate in the intervention;
• Moving to another location that does not have coverage of the ESF, or even to another city.

Sponsors & Collaborators

• Universidade Estadual de Maringá: lead

Study Sites (1)

Universidade Estadual de Maringá

Maringá, Paraná, 87020-900, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Guilherme Arruda, Master

CONTACT

4491663381; enfgoa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: November 28, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2016
• Last Updated: November 28, 2016

Record last verified: 2016-11

Locations

BR (1)