An interventional study of self-care supported in Diabetes Mellitus, sponsored by Universidade Estadual de Maringá. Status unknown at 1 site in Brazil. Open to male participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-11-28.
Sponsored by Universidade Estadual de Maringá · Not applicable, Interventional, and Treatment
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).
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 140 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Universidade Estadual de Maringá is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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.
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).
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).
Time frame: Baseline and six months
Self-care attitudes
Self-care attitudes: measured from QAD questionnaire ( Self Care Questionnaire in Diabetes). For the analysis of adherence to the questionnaire items, they will be parameterized in number of days per week, from zero to seven, zero being the least desirable and seven to more favorable situation, with the exception of items the size specific power that question assessing the consumption of foods rich in fat and sweets, for which the values are reversed, Ie in relation to these foods, the higher the score, or the number of days, the less desirable it is. It will be evaluated by the average number of days. comparisons will be made between the beginning and at the end of the intervention.
Time frame: Baseline and six months
Self-efficacy (or Empowerment)
Self-efficacy (or Empowerment): measured from the self-efficacy scale in diabetes - short version (EAD -VC). The questionnaire addresses the training for the care of diabetes. Eight statements for which the respondent demonstrate their level of agreement, using a Likert scale of five points that part of "strongly disagree" (one point ) to" strongly agree" (five points). The overall score is calculated by the average of the scores of each of the eight items. It is considered high a score of 3.8-5.0, an average of 2.4-3.7 and low at 1-2.3. comparisons will be made between the beginning and at the end of the intervention.
Time frame: Baseline and six months
Psychological adjustment
Psychological adjustment: We used the ATT -19 instrument, which contains 19 items and describes the emotional responses of the DM. Each statement is answered with the help of a kind of scale Likert five points, from " Strongly disagree" to" Strongly agree". TTA -19 Apontuação will 19-95 points. To achieve a positive attitude about DM, the user needs to achieve a minimum score of 70 points. comparisons will be made between the beginning and at the end of the intervention.
Time frame: Baseline and six months
Knowledge about diabetes
Knowledge about diabetes: test was used which has a total score of 15 points, addressing the knowledge of the DM. The DKN-A is associated with psychological, hypoglycemia, insulin, food groups, replacement of food, DM management and general principles of care of the disease. To show a satisfactory knowledge of the DM, the user needs to do at least 8 points. comparisons will be made between the beginning and at the end of the intervention.
Time frame: Baseline and six months
Clinical indicators of cardiometabolic control
Clinical indicators of cardiometabolic control (Blood Pressure, Body Fat Percentage, CA, WHR, BMI, weight, fasting glucose, triglycerides, total cholesterol, HDL, LDL, Creatinine Plasma). comparisons will be made between the beginning and at the end of the intervention.
Time frame: Baseline and six months
Height
Height in meters (m), measured by portable stadiometer.
Time frame: Baseline and six months
Weight
Weight in kilograms (kg), measured by means of a portable scale.
Time frame: Baseline and six months
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Universidade Estadual de Maringá