HypertensionNCT02249494
Mobile Application to Improve Nutritional Counseling Provided by Primary Care Physicians for Hypertension.
A study testing telehealth, nutritional counseling and smartphone (mobile app) in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is to investigate whether the use of a mobile app could improve knowledge and practice in nutrition counseling performed by primary care physicians in Brazil. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension
- What is being tested?
- telehealth, nutritional counseling and smartphone (mobile app)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2014to Jan 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- primary care physicians registered in TelessaúdeRS (Center for Telehealth)
- primary care physicians who use smartphone or tablet
Who cannot join
- not to work in primary care
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Núcleo de Telessaúde Técnico-Científico do Rio Grande do Sul. Universidade Federal do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90430-090
About this study
Official title: Nutritional Recommendations for Hypertension: Development of Mobile Application for Improve Knowledge in Lifestyle Modification for Primary Care Physicians
The purpose of this study is to investigate whether the use of a mobile app could improve knowledge and practice in nutrition counseling performed by primary care physicians in Brazil.
Read the detailed description
To optimize the nutritional care in the context of the limitations of available time and knowledge in medical practice, the present study proposes to develop a tool of nutritional guidelines for hypertension, easily accessible, based on evidence, and then evaluate its use among primary care physicians registered in a center telehealth. The use of the mobile application tool will aim to improve the nutritional counseling, helping with prevention of other chronic diseases in primary care context.
- Conditions
- Hypertension
- Being tested
- telehealth, nutritional counseling, smartphone (mobile app)
- Keywords
- Nutritional Knowledge, Nutritional Counseling
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telehealthOther
Use the call service offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can call when they have questions about diagnosis and management of their patients.
nutritional counselingOther
Performing routine nutritional counseling in their clinical practice
smartphone (mobile app)Device
Mobile app, designed to provide nutritional recommendations for hypertensive patients, will be use. The recommendations will be based on the DASH diet guidelines appropriate to the patient profile: consumption of whole grains, fruits, vegetables, milk or low fat dairy products, lean meats, poultry and fish, nuts, seeds and legumes, amount of fats, oils and sweets, as well as guidelines for salt intake and alcohol.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone (mobile app) & telehealth | Experimental | Participants will install and use a mobile application designed to provide nutritional recommendations for hypertensive patients. These recommendations will be based on the DASH diet guidelines appropriate to patient profile: consumption of whole grains, fruits, vegetables, milk or low fat dairy products, lean meats, poultry and fish, nuts, seeds and legumes, amount of fats, oils and sweets, as well as guidelines for salt intake and alcohol. The call service will be offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can use this call center when they have questions about diagnosis and management of their patients. Receives: Other: telehealth; Other: nutritional counseling; Device: smartphone (mobile app) |
| nutritional counseling & telehealth | Placebo comparator | Physicians who are enrolled for this group will continue performing routine nutritional counseling in their clinical practice. The call service will be offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can use this call service when they have questions about diagnosis and management of their patients. Receives: Other: telehealth; Other: nutritional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score of knowledge and ability related to nutritional care.
For each correct answer, participant will get one point on the knowledge test and for each incorrect answer will get 0. Thus, possible scores will range from 69 to 0. Data based on questions about the abilities will be summarized in a qualitative ranking.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Erno Harzheim, doctor, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249494
- Sponsor's protocol ID
- 14-0258
- Status last verified
- Mar 2015
- First submitted
- 23 Sep 2014
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gadenz SD, Harzheim E, Rados DRV, Castro SMJ, Drehmer M. Mobile Application Increased Nutrition Knowledge Among Brazilian Physicians. J Nutr Educ Behav. 2024 Feb;56(2):92-99. doi: 10.1016/j.jneb.2023.11.001. Epub 2023 Dec 21.
PubMed 38127014
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Recommendations for Hypertension: Development of Mobile Application for Improve Knowledge in Lifestyle Modification for Primary Care Physicians
- ClinicalTrials.gov ID
- NCT02249494
- Acronym / sponsor ID
- 14-0258
- Conditions
- Hypertension
- Keywords
- Nutritional Knowledge, Nutritional Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 25 Sep 2014 (estimated)
- 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.
The purpose of this study is to investigate whether the use of a mobile app could improve knowledge and practice in nutrition counseling performed by primary care physicians in Brazil.
Detailed description
To optimize the nutritional care in the context of the limitations of available time and knowledge in medical practice, the present study proposes to develop a tool of nutritional guidelines for hypertension, easily accessible, based on evidence, and then evaluate its use among primary care physicians registered in a center telehealth. The use of the mobile application tool will aim to improve the nutritional counseling, helping with prevention of other chronic diseases in primary care context.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone (mobile app) & telehealth | Experimental | Other: telehealth, Other: nutritional counseling, Device: smartphone (mobile app)Participants will install and use a mobile application designed to provide nutritional recommendations for hypertensive patients. These recommendations will be based on the DASH diet guidelines appropriate to patient profile: consumption of whole grains, fruits, vegetables, milk or low fat dairy products, lean meats, poultry and fish, nuts, seeds and legumes, amount of fats, oils and sweets, as well as guidelines for salt intake and alcohol. The call service will be offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can use this call center when they have questions about diagnosis and management of their patients. |
| nutritional counseling & telehealth | Placebo comparator | Other: telehealth, Other: nutritional counselingPhysicians who are enrolled for this group will continue performing routine nutritional counseling in their clinical practice. The call service will be offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can use this call service when they have questions about diagnosis and management of their patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- primary care physicians registered in TelessaúdeRS (Center for Telehealth)
- primary care physicians who use smartphone or tablet
Key exclusion criteria (1 listed)
- not to work in primary care
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 |
|---|---|---|
| telehealthUse the call service offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can call when they have questions about diagnosis and management of their patients. | Other | Smartphone (mobile app) & telehealth, nutritional counseling & telehealth |
| nutritional counselingPerforming routine nutritional counseling in their clinical practice | Other | Smartphone (mobile app) & telehealth, nutritional counseling & telehealth |
| smartphone (mobile app)Mobile app, designed to provide nutritional recommendations for hypertensive patients, will be use. The recommendations will be based on the DASH diet guidelines appropriate to the patient profile: consumption of whole grains, fruits, vegetables, milk or low fat dairy products, lean meats, poultry and fish, nuts, seeds and legumes, amount of fats, oils and sweets, as well as guidelines for salt intake and alcohol. | Device | Smartphone (mobile app) & telehealth |
Primary outcome
Change in score of knowledge and ability related to nutritional care.
Time frame: 30 days
For each correct answer, participant will get one point on the knowledge test and for each incorrect answer will get 0. Thus, possible scores will range from 69 to 0. Data based on questions about the abilities will be summarized in a qualitative ranking.
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 19 Mar 2015.
- Derived from this study: PubMed 38127014Gadenz SD, Harzheim E, Rados DRV, Castro SMJ, Drehmer M. Mobile Application Increased Nutrition Knowledge Among Brazilian Physicians. J Nutr Educ Behav. 2024 Feb;56(2):92-99. doi: 10.1016/j.jneb.2023.11.001. Epub 2023 Dec 21.
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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.
Erno Harzheim, doctor principal investigator
Federal University of 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 telehealth, nutritional counseling and smartphone (mobile app) in people with Hypertension, run by Hospital de Clinicas de Porto Alegre 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 2 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 19 Mar 2015. 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. Some participants in this study may receive a placebo. 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?
Change in score of knowledge and ability related to nutritional care. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02249494, which also lists 1 linked publication.
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 19 Mar 2015.