Clinical trial NCT02974413: Effectiveness of Self-care Rests on Knowledge, Self-care and Cardiometabolic Control of Adult Men With Diabetes Mellitus
Official title: Effectiveness of Self-care Rests on Knowledge, Self-care and Cardiometabolic Control of Adult Men With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Universidade Estadual de Maringá
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 140
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Glycemic control
timeFrame: Baseline and six months
Secondary outcomes:
measure: Self-care attitudes
timeFrame: Baseline and six months
measure: Self-efficacy (or Empowerment)
timeFrame: Baseline and six months
measure: Psychological adjustment
timeFrame: Baseline and six months
measure: Knowledge about diabetes
timeFrame: Baseline and six months
measure: Clinical indicators of cardiometabolic control
timeFrame: Baseline and six months
measure: Height
timeFrame: Baseline and six months
measure: Weight
timeFrame: Baseline and six months
Other outcomes:
Locations:
city: Maringá
country: Brazil
facility: Universidade Estadual de Maringá
state: Paraná
Study officials:
References: