Diabetes MellitusNCT03558581
Nursing Interventions for Glycemic Control
A study testing Educational in people with Diabetes Mellitus and Chronic Kidney Diseases, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Chronic Kidney Diseases
- What is being tested?
- Educational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe uncorrected deficiency in hearing, speech,
- total amaurosis,
- degenerative neurological diseases,
- score less than 20 in the Mini Mental State Examination
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pontificia Universidade Católica Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90.619-900
About this study
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.
Read the 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:
- Teaching: individual and Teaching: disease process.
- Control of hyperglycemia and Control of hypoglycemia.
- Teaching: prescription drugs (prescription drugs, was carried out focusing on oral hypoglycemic agents and insulin)
- 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
- Teaching: Foot care.
- 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)
- Conditions
- Diabetes Mellitus, Chronic Kidney Diseases
- Being tested
- Educational
- Keywords
- Nursing Process, Nephrology Nursing, Education Health
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Chronic, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationalOther
Also called Teaching: individual and Teaching: disease process., Control of hyperglycemia and Control of hypoglycemia., Teaching: prescription drugs, Teaching: psychomotor skills.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients have not received any special intervention, the follow up care was the standard care for the specific clinic |
| Intervention | Experimental | After initial allocation the select patient received six educational interventions selected from Nursing Intervention Classification (NIC) Receives: Other: Educational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control - HbA1< 7%
blood sample after NIC interventions
Measured: 1 year
Secondary outcomes (1)
Improve Knowledge assessed by questionaries DKNA
DKNA has 15 multiple choice response items and covers aspects related to the general knowledge of diabetes mellitus. The questions are about basic physiology, food groups and substitutions, DM management in case of complications, and general principles of disease care).
The measurement scale used is from 0 to 15. A score (1) is assigned for correct answer and zero (0) for incorrect. Score greater than eight indicates knowledge about diabetes mellitus
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study startNov 2016
- Primary completionMay 2018
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Elizabeth Prado Lima Figueiredo, Pontificia Universidade Católica do Rio Grande do Sul
- Investigators
- Claudia Capellari, Master, Principal investigator, Pontificia Universidade Católica do Rio Grande do SulAna Figueiredo, PhD, Principal investigator, Pontificia Universidade Católica do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558581
- Sponsor's protocol ID
- EnfDiaTrial
- Status last verified
- Jun 2018
- First submitted
- 30 Apr 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Interventions for Glycemic Control
- ClinicalTrials.gov ID
- NCT03558581
- Acronym / sponsor ID
- EnfDiaTrial
- Conditions
- Diabetes Mellitus, Chronic Kidney Diseases
- Keywords
- Nursing Process, Nephrology Nursing, Education Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Aug 2018 (estimated)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Teaching: individual and Teaching: disease process.
- Control of hyperglycemia and Control of hypoglycemia.
- Teaching: prescription drugs (prescription drugs, was carried out focusing on oral hypoglycemic agents and insulin)
- 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
- Teaching: Foot care.
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients have not received any special intervention, the follow up care was the standard care for the specific clinic |
| Intervention | Experimental | Other: EducationalAfter initial allocation the select patient received six educational interventions selected from Nursing Intervention Classification (NIC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- severe uncorrected deficiency in hearing, speech,
- total amaurosis,
- degenerative neurological diseases,
- score less than 20 in the Mini Mental State Examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationalAlso: Teaching: individual and Teaching: disease process., Control of hyperglycemia and Control of hypoglycemia., Teaching: prescription drugs, Teaching: psychomotor skills. | Other | Intervention |
Primary outcome
Glycemic control - HbA1< 7%
Time frame: 1 year
blood sample after NIC interventions
1 secondary outcome
Improve Knowledge assessed by questionaries DKNA
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Capellari, Master principal investigator
Pontificia Universidade Católica do Rio Grande do Sul
Ana Figueiredo, PhD principal investigator
Pontificia Universidade Católica do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational in people with Diabetes Mellitus and Chronic Kidney Diseases, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control - HbA1< 7% (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.