DengueNCT05321264
Educational Intervention to Promote Control Behaviors and Prevention of Dengue
A study testing Educational nursing intervention in people with Dengue, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
This study will assess the effect of an educational nursing intervention in adults to promote dengue control and prevention behaviors, in comparison with the usual strategy of a health service provider institution. The intervention uses the Nola Pender Health Promotion Model as a theoretical framework. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dengue
- What is being tested?
- Educational nursing intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteColombia
- Study dates
- 9 Sep 2023to 21 Nov 2023
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years old.
- Inhabitant of the rural area.
- Participant in health promotion and disease prevention programs.
- Initial score less than or equal to 3.5 on the NOC outcomes: risk control and participation in health care decisions.
Who cannot join
- People with a score less than or equal to 24 on the cognitive mini mental test.
- Incomplete registration of information in databases of a health service provider institution.
- People with dengue (dengue with warning signs, and severe dengue).
- People who do not have mobile phone availability.
- Illiterate people.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nursing Intervention in Adults to Promote Dengue Prevention and Control Behaviors
This study will assess the effect of an educational nursing intervention in adults to promote dengue control and prevention behaviors, in comparison with the usual strategy of a health service provider institution. The intervention uses the Nola Pender Health Promotion Model as a theoretical framework. Findings will be assessed using the nursing outcomes "risk control" and "participation in health care decisions" from the Nursing Outcomes Classification (NOC).
Read the detailed description
Annually, there are 390 million cases of dengue, mostly due to the inadequate application of sanitary behaviors in the management and control of the vector, having as background the lack of knowledge of the population in the appropriation and incorporation of sanitary measures in the different environments. In addition to the cognitive and behavioral component, dengue has cultural, political, social and economic causes.
The evidence indicates that, from health education, educational interventions have been developed to reduce the disease, but most of them have not been carried out in rural areas following a theoretical framework that guides the intervention that leads to an impact on health promoting behaviors.
The use of the NOC results makes it possible to visualize the impact of nursing care and constitute scientific support for the advancement of the nursing discipline.
- Conditions
- Dengue
- Being tested
- Educational nursing intervention
- Keywords
- Standardized Nursing Terminology, Prevention & control, Dengue
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational nursing interventionBehavioural
Four weekly individualized intervention sessions, with a duration of 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention is defined as educational support (improving the knowledge of the disease, identification of risks and consequences), behavioral support (promoting skills related to personal, home, and environmental self-care) and attitudinal support (reflecting on benefits and risks). Receives: Behavioral: Educational nursing intervention |
| Control | No intervention | Control group will receive the usual strategy of a health service provider institution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk control
NOC outcome. Personal actions to understand, prevent, eliminate, or reduce modifiable health threats. It includes indicators such as identifies risk factors, acknowledges ability to change behavior, develops effective risk control strategies, commits to risk control strategies and modifies lifestyle to reduce risk. This outcome will be evaluated by a Likert scale, being 1 the worst score and 5 best score.
Measured: 2 months
Secondary outcomes (1)
Participation in health care decisions
NOC outcome. Personal involvement in selecting and evaluating health care options to achieve desired outcome. It includes indicators such as identifies health outcome priorities, specifies health outcome preference and identifies barriers to desired outcome achievement. This outcome will be evaluated by a Likert scale, being 1 the worst score and 5 best score.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start9 Sep 2023
- Primary completion14 Oct 2023
- Study completion21 Nov 2023
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 DengueStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilson Canon Montanez, PhD, Study director, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321264
- Sponsor's protocol ID
- 2021-29
- Status last verified
- Jun 2023
- First submitted
- 1 Apr 2022
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Llorente Perez YJ, Rodriguez-Acelas AL, Mattiello R, Canon-Montanez W. Effectiveness of a Nursing Educational Intervention in Adults to Promote Control Behaviors Against Dengue: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 23;13:e54286. doi: 10.2196/54286.
PubMed 38393755
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Intervention in Adults to Promote Dengue Prevention and Control Behaviors
- ClinicalTrials.gov ID
- NCT05321264
- Acronym / sponsor ID
- 2021-29
- Conditions
- Dengue
- Keywords
- Standardized Nursing Terminology, Prevention & control, Dengue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 9 Sep 2023 (actual)
- Primary completion
- 14 Oct 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 11 Apr 2022 (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.
This study will assess the effect of an educational nursing intervention in adults to promote dengue control and prevention behaviors, in comparison with the usual strategy of a health service provider institution. The intervention uses the Nola Pender Health Promotion Model as a theoretical framework. Findings will be assessed using the nursing outcomes "risk control" and "participation in health care decisions" from the Nursing Outcomes Classification (NOC).
Detailed description
Annually, there are 390 million cases of dengue, mostly due to the inadequate application of sanitary behaviors in the management and control of the vector, having as background the lack of knowledge of the population in the appropriation and incorporation of sanitary measures in the different environments. In addition to the cognitive and behavioral component, dengue has cultural, political, social and economic causes.
The evidence indicates that, from health education, educational interventions have been developed to reduce the disease, but most of them have not been carried out in rural areas following a theoretical framework that guides the intervention that leads to an impact on health promoting behaviors.
The use of the NOC results makes it possible to visualize the impact of nursing care and constitute scientific support for the advancement of the nursing discipline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Educational nursing interventionThe intervention is defined as educational support (improving the knowledge of the disease, identification of risks and consequences), behavioral support (promoting skills related to personal, home, and environmental self-care) and attitudinal support (reflecting on benefits and risks). |
| Control | No intervention | –Control group will receive the usual strategy of a health service provider institution. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 18 years old.
- Inhabitant of the rural area.
- Participant in health promotion and disease prevention programs.
- Initial score less than or equal to 3.5 on the NOC outcomes: risk control and participation in health care decisions.
Key exclusion criteria (5 listed)
- People with a score less than or equal to 24 on the cognitive mini mental test.
- Incomplete registration of information in databases of a health service provider institution.
- People with dengue (dengue with warning signs, and severe dengue).
- People who do not have mobile phone availability.
- Illiterate people.
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 |
|---|---|---|
| Educational nursing interventionFour weekly individualized intervention sessions, with a duration of 40 minutes. | Behavioural | Intervention |
Primary outcome
Risk control
Time frame: 2 months
NOC outcome. Personal actions to understand, prevent, eliminate, or reduce modifiable health threats. It includes indicators such as identifies risk factors, acknowledges ability to change behavior, develops effective risk control strategies, commits to risk control strategies and modifies lifestyle to reduce risk. This outcome will be evaluated by a Likert scale, being 1 the worst score and 5 best score.
1 secondary outcome
Participation in health care decisions
Time frame: 2 months
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 29 Dec 2023.
- Derived from this study: PubMed 38393755Llorente Perez YJ, Rodriguez-Acelas AL, Mattiello R, Canon-Montanez W. Effectiveness of a Nursing Educational Intervention in Adults to Promote Control Behaviors Against Dengue: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Feb 23;13:e54286. doi: 10.2196/54286.
- 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.
Wilson Canon Montanez, PhD study director
Universidad de Antioquia
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 nursing intervention in people with Dengue, run by Universidad de Antioquia at 1 site in Colombia.
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 5 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 29 Dec 2023. 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 Colombia. 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?
Risk control (time frame: 2 months). 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 NCT05321264, 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 29 Dec 2023.