Clinical trial NCT03558581: Nursing Interventions for Glycemic Control
Official title: Nursing Interventions for Glycemic Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Chronic Kidney Diseases
Keywords: Nursing Process
Nephrology Nursing
Education Health
Lead sponsor: Pontificia Universidade Católica do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Diabetes mellitus (DM) is a very frequent pathology, which can lead to renal failure and the need for renal replacement therapy. In people with chronic kidney disease (CKD) and diabetes mellitus (DM), glycemic control is very important for the prevention of microvascular injury. In this context, the Nursing Process (NP) is the instrument to guide care, contributing to the attention of individuals' needs. Objective: To evaluate the results of Nursing Outcomes Classification (NOC), obtained through interventions of the Nursing Interventions Classification (NIC) for the glycemic control, in patients with diabetes in renal replacement therapy, with a diagnosis of Unstable Glycemia, of the North American Nursing Diagnosis - International (NANDA-I). Method: Randomized clinical trial in three dialysis services in southern Brazil. Population: Type I and II diabetes patients on hemodialysis. Sample: Over 18 years old, literate, who accept to participate in the study by signing a Term of Consent Free and Clarified. Exclusion criteria: severe uncorrected deficiency in hearing, speech, total amaurosis, degenerative neurological diseases, or score less than 20 in the Mini Mental State Examination. Randomization occurred by clusters, considering dialysis shifts. The CG followed routine treatment and guidelines, while the IG received nursing interventions on a monthly basis for 6 months. Variables related to NOC scores and the knowledge, attitude and self-care tests for DM were applied before and after the intervention period. After the intervention period, a washout period of 06 months will occur, after which the variables will be collected.

Detailed description: After randomization, the intervention group was assesses by a nurse determining the nursing outcomes (NOC)for the specific nursing diagnosis Unstable glycemia. One educational intervention per month was done:

1. Teaching: individual and Teaching: disease process.
2. Control of hyperglycemia and Control of hypoglycemia.
3. Teaching: prescription drugs (prescription drugs, was carried out focusing on oral hypoglycemic agents and insulin)
4. Teaching: psychomotor skills ( was performed with a view to the management and application of insulin). In case of use oral antiglycemic agent the Teaching: prescription drugs and control of hyperglycaemia and hypoglycemia was repeated
5. Teaching: Foot care.
6. Teaching: activity / prescribed exercises. After the completion of the six intervention patients were assessed for outcome classification the study will contemplate a 6 months washout between the NOC assessment ( end of interventions and final assessment)

Eligibility criteria: Inclusion Criteria:

* diabetic with chronic kidney disease on hemodialysis
* over 18 years old
* literate,
* who accept to participate in the study by signing a Term of Consent Free and Clarified

Exclusion Criteria:

* severe uncorrected deficiency in hearing, speech,
* total amaurosis,
* degenerative neurological diseases,
* score less than 20 in the Mini Mental State Examination

Primary outcomes:
measure: Glycemic control - HbA1< 7%
timeFrame: 1 year
Secondary outcomes:
measure: Improve Knowledge assessed by questionaries DKNA
timeFrame: 1 year
Other outcomes:
measure: Improve attitude and coping of Diabetes assessed by questionaries ATT-19
timeFrame: 1 year
Locations:
city: Porto Alegre
country: Brazil
facility: Pontificia Universidade Católica Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
affiliation: Pontificia Universidade Católica do Rio Grande do Sul
name: Claudia Capellari, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Pontificia Universidade Católica do Rio Grande do Sul
name: Ana Figueiredo, PhD
role: PRINCIPAL_INVESTIGATOR
References: