Effectiveness of Web-based Genomic Nursing Education Intervention

Sponsor
University of Eastern Finland (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03963687
Collaborator
(none)
200
1
2
35.4
5.7

Study Details

Study Description

Brief Summary

There is a research gap of integrating genomics into nursing practice, education and research. Nursing students seldom use genetic-genomic data for understanding the individuality of patients and utilize this in delivering personalized or individualized nursing care. Preparing future nurses in genetic-genomic competencies is a fundamental step for clinical application. This research project may help shape the future of the nursing profession in career development by preparing future nurses to emerging advance technologies in genetics-genomics.

Condition or Disease Intervention/Treatment Phase
  • Other: Standard Nursing Education Intervention
  • Other: New Nursing Education Intervention
N/A

Detailed Description

  1. Background of the Study: Genomic Nursing Care is highly in demand and highly important in the healthcare delivery service, however, there are research gaps of integrating this new approach in nursing education research and clinical practice. Genomic data, sequence data and the like nowadays are quite large transforming the way we provide care to our clients. Nurses are in a unique position to assist with the integration of genetics-genomics into everyday practice. The delivery of a world-leading genomic medicine service will not be possible without the work carried out by nurses across the healthcare service. However, is the nursing workforce ready for this new transformation in healthcare approach? Is the next generation of nurses prepared for delivering genome-based healthcare? What can we do and how we can prepare the future of nursing workforce?

Current evidence shows some of the major challenges like ensuring that nurses have adequate training and support in learning about genetics-genomics concepts. The lack of adequate preparation of nurses to incorporate and utilize the recent advances in genomic healthcare. There are disparities in integrating genomic concepts in the nursing curriculum and general confusion, widespread lack of knowledge, and shared misconceptions about foundational genetic-genomic concepts.

  1. Problem Statement/ Aims: The aim of this research project is to develop a Web-based Genomic Nursing Education Intervention and investigate its effectiveness in increasing the level of knowledge of undergraduate nursing students in genetics-genomics fundamental concepts.

  2. Methods: Randomized controlled trial, cross-over design of two-group pretest and repeated posttest is proposed. Based on GPower calculation, 200 undergraduate nursing students will be needed as sample size. With the help of the University statistician, he double checked it using R -program in calculating the required sample size and shows the same result as the GPower solution. The research material will be collected from Finland and the Philippines.

CURRENT STAGE The University of Eastern Finland Committee on Research Ethics has given a supporting statement for the proposed research - STATEMENT 21/2018 date 16th October 2018. Research permissions has been secured from the universities and institutions who will be participating in this research study. I have already a great international network in my research like collaborators from experts in the field of genomics/genetics nursing in USA, New Zealand, Philippines, Czech Republic, and Finland.

The Finnish translation of the research material is done with the help of language experts. Evaluation and validation of the two Finnish versions of Genomic Nursing Concept Inventory (GNCI) is currently undergoing using the Mandysova's decision tree algorithm for translation and linguistic validation of instruments. Drafting of the contents of Web-based Genomic Nursing Education Intervention in collaboration with USA and New Zealand co-investigators is ongoing.

Research Tool A valid and reliable 31-item scale Genomic Nursing Concept Inventory (GNCI) beta-revised version will be utilized to measure the level of knowledge and understanding of undergraduate nursing students in nursing genetic-genomic concepts. Research tool was obtained from partners in the United States, translated to Finnish and will be back-translated. Pilot testing will be conducted in Finland on September-December 2019. In Philippines, English version will be used and data collection will be conducted September-December 2019. Furthermore, the feedback of the participants with their experiences in using the web-based genomic nursing education intervention will be collected using a survey questionnaire. Data will be collected electronically using the University of Eastern Finland electronic data collection platform during the period of September 2019- September 2020. IBM SPSS Statistics Version 21 will be used to analyze the descriptive and inferential statistics.

  1. Research Design: At Period 1, research participants will be randomly assigned into two groups. Group 1 will receive the Genetics Education Program for Nurses (GEPN) which is available online for more than 20 years. Group 2 will receive the Web-based Genomic Nursing Education which will be designed by the research team based on the results of Pre-test Genomic Nursing Concept Inventory (GNCI). After 4 weeks, post-test of Genomic Nursing Concept Inventory (GNCI) will be implemented and wash out period to deal with the carryover effect or the effect of the treatment from the previous time period on the response at the current time period which can cause bias the interpretation of data analysis. At period 2 is the cross-over. Then another post-test of Genomic Nursing Concept Inventory (GNCI) for evaluation. Single Blind technique will be use, this means, research participants are not aware which educational intervention group they belong.

  2. Research Impact: Web-based Genomic Nursing Education Intervention for undergraduate nursing students may be an effective way to prepare future nurses with genetic-genomics nursing competencies. The outcome of this research can be utilized globally for educating undergraduate nursing students. The web-based intervention can be included in the nursing curriculum and/ or the course and/or syllabus content of different countries. Preparing future nurses in genetic-genomic competencies is the fundamental step for clinical application.

  3. Funding plan/ resources: This project is planned for 4 years and will require the salary of the researcher (via University of Eastern Finland fund). Technical support from university services include statistical services, IT services, open access and language editing services. The research team comprises of interdisciplinary experts in the field of genetics/genomics nursing.

  4. Relevance: This research project may help shape the future of the nursing profession in career development by preparing future nurses to emerging advance technologies in genetics-genomics.

  5. Supervision team/collaborators:

Supervision: Katri Vehviläinen-Julkunen, Project Leader, Main Supervisor,University of Eastern Finland Faculty of Health Sciences, Department of Nursing Science; katri.vehvilainenjulkunen@uef.fi; Carsten Carlberg, PhD, Professor of Biochemistry, University of Eastern Finland, School of Medicine, Institute of Biomedicine, carsten.carlberg@uef.fi

Collaborators: Dr. Linda Ward (expert in nursing genomics and genetics, Clemson University, USA); Dr. Bobbi Laing (expert in nutrigenomics, University of Auckland, New Zealand); Dr. Anecita Gigi Lim (expert in pharmacogenetics, University of Auckland, New Zealand); Prof. Erlinda Palaganas (nurse scientist, University of the Philippines, Philippines); Peter James Abad (Genetic Counsellor, University of the Philippines, Philippines); Ofelia Valdehueza (nursing expert, Don Mariano Marcos Memorial State University, Philippines); Marjo Palovaara (nursing expert, Jyväskylä University of Applied Sciences, Finland); Hannele Saunders (nursing expert, South-Eastern Finland University of Applied Sciences, Finland); Petra Mandysova (nursing expert, University of Pardubice, , Czech Republic); Matti Estola (Statistician, University of Eastern Finland)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomized controlled trial, cross-over design of two-group pretest and repeated posttest is proposed. At Period 1, research participants will be randomly assigned into two groups. Group 1 will receive the Genetics Education Program for Nurses (GEPN) which is available online for more than 20 years. Group 2 will receive the Web-based Genomic Nursing Education which will be designed by the research team based on the results of Pre-test GNCI. After 4 weeks, post-test of GNCI will be implemented and wash out period to deal with the carryover effect or the effect of the treatment from the previous time period on the response at the current time period which can cause bias the interpretation of data analysis. At period 2 is the cross-over. Then another post-test of GNCI for evaluation.Randomized controlled trial, cross-over design of two-group pretest and repeated posttest is proposed. At Period 1, research participants will be randomly assigned into two groups. Group 1 will receive the Genetics Education Program for Nurses (GEPN) which is available online for more than 20 years. Group 2 will receive the Web-based Genomic Nursing Education which will be designed by the research team based on the results of Pre-test GNCI. After 4 weeks, post-test of GNCI will be implemented and wash out period to deal with the carryover effect or the effect of the treatment from the previous time period on the response at the current time period which can cause bias the interpretation of data analysis. At period 2 is the cross-over. Then another post-test of GNCI for evaluation.
Masking:
Single (Participant)
Masking Description:
Single Blind technique will be use, this means, research participants are not aware which educational intervention group they belong.
Primary Purpose:
Other
Official Title:
A Randomized Controlled Trial of the Effectiveness of a Web-based Genomic Nursing Education Intervention on Outcomes of Increasing the Level of Knowledge of Undergraduate Nursing Students in Genetics-genomics Concepts: Study Protocol
Actual Study Start Date :
Jan 20, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control Group

Participants will receive the Standard Nursing Education Intervention first

Other: Standard Nursing Education Intervention
Genetics Education Program for Nurses (GEPN) which is available free online for more than 20 years

Experimental: Intervention Group

Participants will receive the New Nursing Education Intervention first

Other: New Nursing Education Intervention
Web-based Genomics/ Genetics Nursing Education is a free online course that will be designed by the research team.

Outcome Measures

Primary Outcome Measures

  1. Genomic Nursing Concept Inventory test score [3 months]

    Genomic Nursing Concept Inventory test score of 1-10 is low level of knowledge, 11-20 is medium level of knowledge, and 21-31 is high level of knowledge on genetics-genomics concepts.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • senior level, undergraduate nursing students

  • studying in government institution or university/ university of applied sciences

  • willing to participate in the study voluntarily

Exclusion Criteria:
  • graduate nursing students

  • staff nurses

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anndra Margareth Dumo Kuopio Finland 70210

Sponsors and Collaborators

  • University of Eastern Finland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Anndra Dumo, Researcher, University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT03963687
Other Study ID Numbers:
  • Genomics Nursing Education
First Posted:
May 28, 2019
Last Update Posted:
Oct 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anndra Dumo, Researcher, University of Eastern Finland

Study Results

No Results Posted as of Oct 5, 2021