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Nursing Intervention for Knowledge and Self-care Behaviors in the Face of Hypertensive Disorders of Pregnancy (EducaTHE)

Primary Purpose

Hypertensive Disorders of Pregnancy

Status
Recruiting
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Nursing intervention to improve knowledge and self-care behaviors in the face of HDP
Sponsored by
Universidad de Antioquia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertensive Disorders of Pregnancy focused on measuring Knowledge,Self Care,Pregnancy,Nursing, Feasibility Studies

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Pregnant women enrolled in the prenatal care program of a health institution Pregnant women aged 18 years or older Pregnant women with a gestational age equal to or less than 24 weeks determined by the date of the last period or obstetric ultrasound. Pregnant women residing in the urban area. Exclusion Criteria: Pregnant women with chronic conditions such as heart disease, renal disease, or diabetes mellitus. Pregnant women with a history or diagnosis at entry or during the study of HDP according to the classification of the American College of Obstetricians and Gynecologists (ACOG) Pregnant women who are participating in other educational studies or workshops/programs with similar themes to this study. Pregnant women scoring less than 24 points on the Mini-mental status test.

Sites / Locations

  • Local Hospital of PiedecuestaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nursing intervention to improve knowledge and self-care behaviors in the face of HDP

Usual management during prenatal care

Arm Description

Behavioral: Educational, behavioral and motivational intervention developed by nurses aimed at improving the level of knowledge and self-care behaviors of pregnant women in the face of HDP.

Behavioral: Nursing education about maternal care and usual education in maternity preparation course

Outcomes

Primary Outcome Measures

Feasibility: recruitment, attrition, follow-up
Recruitment For the analysis of this variable, the number of pregnant women enrolled in the prenatal control program of the health institution who meet the inclusion criteria of the study, and the number of pregnant women who agree to participate in the study, will be taken into account. Attrition This variable will include the number of pregnant women who agreed to participate, and the number of participants who did not attend or did not complete the four sessions of the intervention. Follow-up This variable will include the number of pregnant women who complete the four sessions of the intervention, and the number of participants who completed the study after the post-intervention measurements.
Acceptability
A survey will be used to assess acceptability. The survey will be divided into three sessions, the first consisting of 13 items aimed at obtaining information related to the contents of the educational material, the activities and the form of delivery of the intervention, dose and interventionist. The second session consisted of 11 items that will evaluate the benefits and weaknesses of the intervention. The third contains 3 open questions related to the taste for the intervention, suggestions and recommendations

Secondary Outcome Measures

Full Information

First Posted
April 2, 2023
Last Updated
April 27, 2023
Sponsor
Universidad de Antioquia
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1. Study Identification

Unique Protocol Identification Number
NCT05837962
Brief Title
Nursing Intervention for Knowledge and Self-care Behaviors in the Face of Hypertensive Disorders of Pregnancy
Acronym
EducaTHE
Official Title
Feasibility and Acceptability of the Nursing Intervention "EducaTHE" to Improve Knowledge and Self-care Behaviors in the Face of Hypertensive Disorders of Pregnancy in Pregnant Women.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
August 16, 2023 (Anticipated)
Study Completion Date
December 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Antioquia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Hypertensive disorders of pregnancy (HDP) are a leading cause of maternal and fetal morbidity and mortality worldwide. The lack of knowledge and self-care behaviors by the pregnant woman in the face of THE could be associated with their appearance. This is a randomized controlled pilot trial type study, with a control group that will receive the usual prenatal care and an intervention group that will additionally receive the nursing intervention to improve knowledge and self-care behaviors in the face of HDP. Each group will include 30 pregnant women, for a total of 60 users. The level of knowledge and self-care behaviors will be assessed before and after the intervention.
Detailed Description
Introduction: the World Health Organization (WHO) indicates that HDP are the third leading cause of maternal death worldwide; and in Latin America and the Caribbean they are positioned as the first cause. The evidence has described that limited or non-existent knowledge and the lack of self-care behaviors by the pregnant woman in the face of HDP are important conditions in the incidence of this obstetric complication. In this sense, nursing must design and implement intervention strategies that have a positive impact on knowledge and self-care behaviors in the face of HDP. Objective: to determine the feasibility and acceptability of the "EducaTHE" nursing intervention to improve knowledge and self-care behaviors in the face of hypertensive disorders of pregnancy in pregnant women. Methods: randomized controlled pilot trial experimental study with pregnant women assigned to an intervention group and a control group. The sample will consist of a total of 40 pregnant women, 20 in each of the study groups. The intervention group will receive the usual education of prenatal control. The control group, in addition to the usual prenatal control information, will receive an educational, behavioral and motivational intervention related to HDP and their self-care behaviors. The intervention will be carried out in 4 sessions, on a weekly basis, in a face-to-face and group. In both groups, knowledge and self-care behaviors will be measured before and 4 weeks after the end of the intervention. Randomization: the assignment will be carried out through a simple randomization process, with an intervention/control ratio 1:1, by means of a sequence of random numbers generated by a statistical program. The assignment will be given by one of the researchers who will not perform the intervention, nor the initial or final evaluation. Expected results: feasibility and acceptability of the study in the context of perinatal maternal care

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Disorders of Pregnancy
Keywords
Knowledge,Self Care,Pregnancy,Nursing, Feasibility Studies

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nursing intervention to improve knowledge and self-care behaviors in the face of HDP
Arm Type
Experimental
Arm Description
Behavioral: Educational, behavioral and motivational intervention developed by nurses aimed at improving the level of knowledge and self-care behaviors of pregnant women in the face of HDP.
Arm Title
Usual management during prenatal care
Arm Type
No Intervention
Arm Description
Behavioral: Nursing education about maternal care and usual education in maternity preparation course
Intervention Type
Behavioral
Intervention Name(s)
Nursing intervention to improve knowledge and self-care behaviors in the face of HDP
Intervention Description
The nursing professional will perform 1 session weekly, for 4 weeks, lasting 90 minutes each. The contents that make up each of the sessions are: Session 1. Knowledge about the risk factors, signs and symptoms, maternal and fetal complications of HDP. Session 2. Control over behaviour, positive attitude and family and social support: essential components for conducting self-care behaviour. Session 3. Nutritional recommendations: eating healthy helps prevent or reduce the risk of developing HDP. Recommendations to improve sleep, rest and physical exercise: key routines in my health to prevent or reduce the risk of developing HDP. Session 4. Mental health promotion: managing my stress, anxiety and depression levels help prevent or decrease the risk of HDP
Primary Outcome Measure Information:
Title
Feasibility: recruitment, attrition, follow-up
Description
Recruitment For the analysis of this variable, the number of pregnant women enrolled in the prenatal control program of the health institution who meet the inclusion criteria of the study, and the number of pregnant women who agree to participate in the study, will be taken into account. Attrition This variable will include the number of pregnant women who agreed to participate, and the number of participants who did not attend or did not complete the four sessions of the intervention. Follow-up This variable will include the number of pregnant women who complete the four sessions of the intervention, and the number of participants who completed the study after the post-intervention measurements.
Time Frame
6 months
Title
Acceptability
Description
A survey will be used to assess acceptability. The survey will be divided into three sessions, the first consisting of 13 items aimed at obtaining information related to the contents of the educational material, the activities and the form of delivery of the intervention, dose and interventionist. The second session consisted of 11 items that will evaluate the benefits and weaknesses of the intervention. The third contains 3 open questions related to the taste for the intervention, suggestions and recommendations
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women enrolled in the prenatal care program of a health institution Pregnant women aged 18 years or older Pregnant women with a gestational age equal to or less than 24 weeks determined by the date of the last period or obstetric ultrasound. Pregnant women residing in the urban area. Exclusion Criteria: Pregnant women with chronic conditions such as heart disease, renal disease, or diabetes mellitus. Pregnant women with a history or diagnosis at entry or during the study of HDP according to the classification of the American College of Obstetricians and Gynecologists (ACOG) Pregnant women who are participating in other educational studies or workshops/programs with similar themes to this study. Pregnant women scoring less than 24 points on the Mini-mental status test.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edier Arias Rojas
Phone
+57 313 4258151
Email
emauricio.arias@udea.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Iliana Ulloa Sabogal
Phone
+57 3115135883
Email
Iliana.ulloa@udea.edu.co
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edier Arias Rojas
Organizational Affiliation
Universidad de Antioquia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Iliana Ulloa Sabogal
Organizational Affiliation
Universidad de Antioquia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Local Hospital of Piedecuesta
City
Santander
State/Province
Piedecuesta
ZIP/Postal Code
681011
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Figueredo Macías
Phone
(607) 6650446
Email
gerencia@hlp.gov.co
First Name & Middle Initial & Last Name & Degree
Angie Gualdrón Carvajal
Phone
(607) 6650446
Email
secretaria@hlp.gov.co

12. IPD Sharing Statement

Learn more about this trial

Nursing Intervention for Knowledge and Self-care Behaviors in the Face of Hypertensive Disorders of Pregnancy

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