NCT05321264

Brief 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. Findings will be assessed using the nursing outcomes "risk control" and "participation in health care decisions" from the Nursing Outcomes Classification (NOC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 9, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2023

Completed
Last Updated

December 29, 2023

Status Verified

June 1, 2023

Enrollment Period

1 month

First QC Date

April 1, 2022

Last Update Submit

December 22, 2023

Conditions

Dengue

Keywords

Standardized Nursing TerminologyPrevention & controlDengue

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 months

Secondary Outcomes (1)

  • Participation in health care decisions

    2 months

Study Arms (2)

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).

Behavioral: Educational nursing intervention

Control

NO INTERVENTION

Control group will receive the usual strategy of a health service provider institution.

Interventions

Educational nursing interventionBEHAVIORAL

Four weekly individualized intervention sessions, with a duration of 40 minutes.

Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yolima Judith Llorente Perez

Medellín, Antioquia, Colombia

Location

Related Publications (1)

  • 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.

    PMID: 38393755DERIVED

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Wilson Canon Montanez, PhD

    Universidad de Antioquia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2022

First Posted

April 11, 2022

Study Start

September 9, 2023

Primary Completion

October 14, 2023

Study Completion

November 21, 2023

Last Updated

December 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CO(1)