Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03729323 |
| Other study ID # |
Grupo Hospitalar Conceicao |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 11, 2018 |
| Est. completion date |
March 12, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
Hospital Nossa Senhora da Conceicao |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this study is to evaluate the effectiveness of Nursing Consultation based on the
assumptions and techniques of Motivational Interviewing for the control of Type 2 diabetes
mellitus with associated diagnosis of Systemic Arterial Hypertension in primary healthcare.
Description:
Type 2 Diabetes Mellitus and Systemic Arterial Hypertension are major challenges to health
systems worldwide, and control, adherence and promotion of self-care are the cornerstone of
their management. In this context, an adequate therapist-patient relationship is the key to
the success of these interventions in healthcare, and nurses have a recognized and
outstanding role in improving adherence and care results in chronic diseases. Motivational
Interviewing (MI) emerges as a skillful method of counseling that has proven to be effective
in promoting changes in a wide variety of health-related behaviors, including hypertension
and diabetes. Despite the increasing number of international studies in different health
fields, the scientific production that assess the applicability of Motivational Interviewing
to chronic diseases in the Brazilian setting is still modest. Recent studies suggest the need
for further research involving the discussion and improvement of studies utilizing
Motivational Interviewing in Brazil, as well as in other countries around the world, for
better outlook on this area of investigation. Therefore, this study intends to contribute to
this perspective and aims to investigate the effectiveness of this care strategy in
individual Nursing consultations for people with DM2 and SAH who are being treated in three
Primary Healthcare Clinics in the Northern Area of Porto Alegre - RS , Brazil, which are an
integral part of the Grupo Hospitalar Conceição (GHC) Community Health Service (SSC). GHC
treats patients from the Brazilian public health system exclusively, with universal and free
access, and the SSC is comprised of 16 primary care and mental health services, caring for a
population of 105,000 inhabitants in the northern and eastern areas of Porto Alegre, RS,
Brazil. This will be a randomized, controlled, parallel and double-blind clinical trial to be
conducted in the period from June to September, 2018.
MAIN GOAL: To evaluate the effectiveness of Nursing Consultation based on the assumptions and
techniques of Motivational Interviewing in the control of Type 2 Diabetes Mellitus with
associated diagnosis of Systemic Arterial Hypertension in primary healthcare.
SPECIFIC GOALS:
- To characterize participants in terms of sociodemographic and economic profile, health
history, and life habits;
- To monitor and assess glycemic and pressure goals before and after intervention;
- To estimate the prevalence of adherence to drug therapy and healthy life habits among
participants before and after intervention;
- To assess self-efficacy for participants' self-care before and after intervention.
- To evaluate the Level of Importance and Confidence to change unhealthy behaviors among
participants with DM2 and SAH, before and after intervention.
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