Nutritional Therapy QualityNCT03351621
The Reality of Nutritional Therapy in Brazil: Quality Assessment
An observational study of Nutritional Therapy Quality, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Nutritional status depletion is associated with complications such as increased morbidity and mortality, worsening of patients' quality of life and increased length of hospital stay. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nutritional Therapy Quality
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2016to Nov 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Hospitals with nutritional therapy (Public, private and teaching hospitals)
Who may be able to join
- Hospitals with nutritional therapy
Who cannot join
- Hospitals with no nutritional therapy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital of Clinics of the University Federal of Minas Gerais
Belo Horizonte, Minas Gerais
About this study
Nutritional status depletion is associated with complications such as increased morbidity and mortality, worsening of patients' quality of life and increased length of hospital stay. Thus, nutritional therapy defined as the set of therapeutic procedures for maintenance or recovery of the nutritional status of the patient, becomes a procedure of extreme importance in the hospital setting. It should be carried out by an interprofessional team, in order to ensure adequate patient care. Aim: This study intends to evaluate the reality of Nutritional Therapy in Brazil, 18 and 14 years after the introduction of the resolution n ° 272 and the RDC n ° 63, respectively, regarding the practice of this important therapy and the existence of interdisciplinary teams. Method: Descriptive, observational and national study. In each Brazilian state was selected the capital, and drawn a city of average and other one of small size. Next, a public, private and university hospital in each municipality was randomly selected. Data collection will be done by means of a questionnaire, based on the Secretary of Sanitary Surveillance of the Ministry of Health resolution n ° 272 and the RDC n ° 63. The questionnaire will be applied by the researchers, and directed to the health professionals involved in the Nutritional Therapy practice in each of the selected hospitals.
- Conditions
- Nutritional Therapy Quality
What is being measured
The primary outcome is the main question the study is designed to answer.
The Reality of Nutritional Therapy in Brazil
The adequacy will be assessed using proper questionnaire prepared up from Resolution of Collegiate Board of the National Health Surveillance Agency Nº 63/2000 and portaria n° 272 of the Ministry of Health.
Measured: December, 2017.
Secondary outcomes (2)
Performance of interdisciplinary teams of nutritional therapy
The performance will be assessed using proper questionnaire prepared up from Resolution of Collegiate Board of the National Health Surveillance Agency Nº 63/2000 and portaria n° 272 of the Ministry of Health.
Measured: December, 2017.
Number of patients in nutritional therapy in hospitals
Own Checklist
Measured: December, 2017.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Feb 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional Therapy QualityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351621
- Sponsor's protocol ID
- CAAE: 56548816.6.0000.5149
- Status last verified
- May 2018
- First submitted
- 3 Nov 2017
- Last updated
- 24 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reality of Nutritional Therapy in Brazil: Quality Assessment
- ClinicalTrials.gov ID
- NCT03351621
- Acronym / sponsor ID
- CAAE: 56548816.6.0000.5149
- Conditions
- Nutritional Therapy Quality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 24 Nov 2017 (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.
Nutritional status depletion is associated with complications such as increased morbidity and mortality, worsening of patients' quality of life and increased length of hospital stay. Thus, nutritional therapy defined as the set of therapeutic procedures for maintenance or recovery of the nutritional status of the patient, becomes a procedure of extreme importance in the hospital setting. It should be carried out by an interprofessional team, in order to ensure adequate patient care. Aim: This study intends to evaluate the reality of Nutritional Therapy in Brazil, 18 and 14 years after the introduction of the resolution n ° 272 and the RDC n ° 63, respectively, regarding the practice of this important therapy and the existence of interdisciplinary teams. Method: Descriptive, observational and national study. In each Brazilian state was selected the capital, and drawn a city of average and other one of small size. Next, a public, private and university hospital in each municipality was randomly selected. Data collection will be done by means of a questionnaire, based on the Secretary of Sanitary Surveillance of the Ministry of Health resolution n ° 272 and the RDC n ° 63. The questionnaire will be applied by the researchers, and directed to the health professionals involved in the Nutritional Therapy practice in each of the selected hospitals.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Hospitals with nutritional therapy (Public, private and teaching hospitals)
Key inclusion criteria (1 listed)
- Hospitals with nutritional therapy
Key exclusion criteria (1 listed)
- Hospitals with no nutritional therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Reality of Nutritional Therapy in Brazil
Time frame: December, 2017.
The adequacy will be assessed using proper questionnaire prepared up from Resolution of Collegiate Board of the National Health Surveillance Agency Nº 63/2000 and portaria n° 272 of the Ministry of Health.
2 secondary outcomes
Performance of interdisciplinary teams of nutritional therapy
Time frame: December, 2017.
Number of patients in nutritional therapy in hospitals
Time frame: December, 2017.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Therapy Quality, run by Federal University of Minas Gerais 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Reality of Nutritional Therapy in Brazil (time frame: December, 2017.). 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 24 May 2018.