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DisasterNCT05544578

Korean Translation and Validation of the K-HEPI in NYC

A study testing Nurses Taking On Readiness Measures (N- TORM) in people with Disaster and Vulnerable Populations, run by Hunter College of City University of New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Nurses Taking on Readiness Measures (N-TORM) is an innovative nurse-driven household emergency preparedness intervention modeled after an existing community intervention provided by emergency management personnel. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Disaster, Vulnerable Populations
What is being tested?
Nurses Taking On Readiness Measures (N- TORM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUnited States
Study dates
13 Jul 2023to 19 Jul 2024
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older
  • 1 participant pr household
  • understand and read Korean
  • lives independently within the New York metropolitan area (i.e., not in a rehabilitation facility, long-term care facility, halfway house or prison)
  • consents to participate

Who cannot join

  • less than 18 years of age
  • cognitive impairments
  • Non-Korean speaking
  • Non-Korean reading

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Hunter College, City University of New York

    New York, New York, 10010

Other trials in United States

About this study

Official title: Korean Translation and Validation of the Household Emergency Preparedness Instrument (K- HEPI) by a Phase 1 Feasibility Study in New York City

Nurses Taking on Readiness Measures (N-TORM) is an innovative nurse-driven household emergency preparedness intervention modeled after an existing community intervention provided by emergency management personnel. The proposed pilot studies will test the Korean translation of the Household Emergency Preparedness Instrument (K-HEPI) and describe the implementation and effectiveness of N-TORM in a community setting. The aims of this instrument translation study and cluster randomized controlled trial are to (a) field and pilot test the K-HEPI in order to perform psychometric testing on the instrument and generate reliability and validity data, (b) increase the accessibility of N-TORM to vulnerable populations, (c) evaluate the effectiveness of N-TORM to increase household emergency preparedness knowledge and behavior, (d) implement N-TORM in a community located in an area at increased risk for disasters, measuring consistency of delivery, time, and cost of N-TORM, and (e) describe the factors most necessary to maintain and expand N-TORM.

Read the detailed description

The proposed instrument translation study will pilot test a Korean version of the Household Emergency Preparedness Instrument to perform psychometric testing on the instrument, generating reliability and validity data for an examination of cross-cultural equivalence.

Following the instrument translation study, the investigators will use the K-HEPI in a cRCT to measure the level of household emergency preparedness of an at-risk population before and after receiving the N-TORM intervention to measure intervention effectiveness and health impacts of an extreme weather event. The investigators will compare the intervention group's K-HEPI scores to the control group's K-HEPI scores at baseline, one-month follow up, and after an extreme weather event.

Hypotheses (H):

H1: The level of household emergency preparedness, as measured by the K-HEPI, will increase after an educational intervention.

H2: The K-HEPI will account for a significant proportion of the variance in emergency preparedness among the sampled Korean households.

H3: Households who participate in the N-TORM educational intervention will show significantly greater increases in household emergency preparedness, as measured by the K-HEPI, than households that do not participate in the intervention.

H 4.1: Factors commonly found to be predictors of household emergency preparedness will be significantly associated with post-test levels of household emergency preparedness both for participants who do (experimental group) and do not (control group) complete the intervention.

H 4.2: Factors commonly found to be predictors of household emergency preparedness will significantly interact with whether or not participants complete the intervention, such that barriers will affect those who do not complete the intervention more than they affect those who do complete it.

H 5.1: The inter-item reliability of the K-HEPI will be similar to that of the English version.

H 5.2: Confirmatory factor analysis will find a significant fit of the K-HEPI to the same factor structure of the items that is found in the English version.

H 5.2.1: Model fit indices for the Korean version will be similar to those of the English version.

Background:

Worldwide, extreme weather events and disasters continue to have devastating impacts on households, communities, and nations with increased morbidity, mortality, and infrastructural and economic devastation. Disasters are unforeseen events that overwhelm local capacity, often resulting in a request at the national or international level for external assistance. The Federal Emergency Management Agency, Centers for Disease Control, American Red Cross, and local government agencies have socially marketed the importance of household emergency preparedness for years, yet the US public largely remains unprepared for disasters. Although household emergency preparedness has not been empirically demonstrated to result in decreased disaster-related morbidity and mortality, it is plausible that self-sufficiency of households will result in disaster resilience. Families must prepare for conditions that all disasters create, regardless of geographical area or type of disaster, such as loss of electricity, water, and being unable to obtain supplies for several days due to the need for sheltering in place or disruptions in the supply chain. A household is considered prepared if members have created a family communication and evacuation plan and assembled a disaster kit containing enough food and water to sustain each member for at least one week.

In September 2021, due to Hurricane Ida flooding, at least 13 people died in New York City. Eleven died in their basement-level homes in Queens, and nearly all the victims were residents of Asian descent who lived in low-income Asian immigrant communities. According to the 2020 Census data, Asians represented about 14.3% of the population in New York City and 26% of Queens. Asians in New York City are more likely to be foreign born immigrants than other major racial groups. Undocumented immigrants are particularly vulnerable to social marginalization, low socioeconomic status, lack of societal resources, and limited English proficiency, resulting in difficulties seeking help during extreme weather events. However, Asian Americans' emergency preparedness has rarely been measured in disaster research. As a result of the experience of living through Hurricane Ida, members of the Asian immigrant community requested household emergency preparedness education and community interventions from members of the study team.

The study data can build evidence for a promising individual and community household emergency preparedness intervention. The effectiveness of N-TORM to increase household emergency preparedness knowledge and behavior can be evaluated so that the intervention may be revised and replicated within different populations. This intervention can also be used in longitudinal studies to determine whether there is an association between being prepared for a disaster and surviving the disaster without the need for rescue or outside assistance. For medically frail community members, it can be determined whether there is an association between being prepared for a disaster and surviving the disaster without an acute exacerbation of a chronic illness and with no change in baseline functional status.

Study Design: K-HEPI Translation and Field Testing

The HEPI will be translated and field tested according to the recommended instrument translation procedures of Feher Waltz et al., (2010, pp. 452-458) and Sperber (2004). The English to Korean translation will follow a symmetrical translation, utilizing a decentered process. This means both the source and target languages are considered equally important, with both versions of the instrument remaining loyal to meanings and open to revision. Investigators from two different cultures (US and South Korea) will collaborate on the translation.

Study Design: K-HEPI Pilot Testing and N-TORM Intervention

Once the final version of the translated HEPI is achieved, the instrument will be used in a cRCT study with the target population. The intervention versus control data collection sites will be the unit of randomization.

Only approved research personnel will be involved in the research procedures. The investigators are employed at Hunter College, the City University of New York, and their duties in this study will be conducted under their role as employees of Hunter College. In addition, Korean-speaking research assistants and community health workers will be hired and trained to assist with study procedures.

The intervention group will receive two, 1-hour, in-person classes to help them develop their family evacuation and communication plans, identify community resources, and assemble a disaster supply kit. Trained study personnel will use a lecture and the Korean version of a New York City community-specific booklet called Ready New York: My Emergency Plan as a handout to educate the participants about the essentials of household emergency preparedness. The control group will receive the Korean version of the 2-page Prepared New York: Disaster and Emergency Preparation pocket guide after data collection.

Recruitment Procedures. Potential K-HEPI Pilot Testing / N-TORM participants will be recruited from Korean Community Services of Metropolitan New York, Inc. (KCS).

Risks and Benefits. There is no more than minimal risk for participation in this study. Little to no feelings of discomfort are expected. There are no direct benefits to participating in this study. This research does not claim to present a therapeutic benefit to the participants. Participants who successfully complete the N-TORM intervention may be self-sufficient for up to 72-hours post-disaster, but the association between disaster preparedness level and disaster resilience has not been empirically tested. It is anticipated that this study will benefit society.

Intervention Fidelity. The principal investigator (PI) will educate the study team members on how to deliver the N-TORM intervention. Each study team member who will serve as an N-TORM instructor will demonstrate competency in intervention delivery by teaching back the intervention to the PI. The PI and study team will evaluate the N-TORM intervention delivery of each team member by providing praise and any necessary critique/corrective feedback after the practice session. All instructors will use the same presentation and booklet and will adhere to the study protocol methods. The PI or Site PI will observe at least one N-TORM session by each instructor to monitor intervention fidelity. The investigators will keep a record of how often the instructors met, what was covered, and length of time it took to deliver the intervention.

The N-TORM intervention will take place at faith- and community-based organizations affiliated with the Korean Community Services of Metropolitan New York, Inc. who agree to recruit participants and host the N-TORM intervention at their site. The participants' portion of the intervention will take place in their homes, between classes 1 and 2.

Data Analysis. Descriptive statistics of the sample will be reviewed prior to regression analyses examining the associations between the study variables. Hierarchical linear regression analyses with time nested in participants will be conducted. The change in the level of household emergency preparedness will be evaluated with the pre- and post-intervention scores on the K-HEPI. The improvement from pretest to posttest will be analyzed through repeated measures ANOVAs; the main goal of these ANOVAs is to test the effect of participation in the N-TORM intervention. However, one of the models will also include demographics covariates and variables measuring common facilitators and barriers to household emergency preparedness to test their effects on K-HEPI scores and the effectiveness of the intervention considering them. In addition, the change in score will be evaluated with a repeated measures matched pairs t-test. Finally, the mean household emergency preparedness pretest score for all the participants will be compared to the mean posttest score with a percentage change calculation.

The reliability of the HEPI will be measured by looking at the internal consistency of the items (ordinal α coefficients and item-total correlations). Confirmatory factor analysis using polychoric correlations will be used to examine the factor structure of the K-HEPI and to compare it with that of the English version. Known-group validity of the K-HEPI will be assessed by comparing the scores of the participants who self-reported that they were unprepared for a disaster before and after the N-TORM intervention.

Being tested
Nurses Taking On Readiness Measures (N- TORM)
Keywords
immigrants, civil defense, hazard, emergency, preparedness, planning, readiness, kit, disaster planning, emergency preparedness, community, community nursing, health surveys, intervention study
Medical subject headings
Emergencies, Piebaldism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nurses Taking On Readiness Measures (N- TORM)Behavioural

    The intervention group will be educated about household emergency preparedness via a presentation and the Korean version of a New York City community-specific booklet called Ready New York: My Emergency Plan (NYC Emergency Management, 2022). The intervention will begin with instructing the participant to start the booklet during class 1 and completing it for homework. The class content will complement the booklet and the K-HEPI. The booklet includes preparedness recommendations, evacuation zone information, a disaster supply kit contents list, local utility company contact information, shelter locations, and special needs and priority utility restoration registry information. During class 2, study personnel will check for completion of the booklets, answer any questions that the participants may have about the evacuation and communication plans and disaster kits, and facilitate group discussion to foster social support from other community members.

Study groups in NCT05544578
Study groupRoleWhat they receive
Nurses Taking On Readiness Measures (N-TORM) Intervention GroupExperimentalThis is a phase 1 feasibility study via a cluster randomized controlled trial.
Receives: Behavioral: Nurses Taking On Readiness Measures (N- TORM)
Disaster and Emergency Preparation Pocket Guide Control GroupNo interventionThe control group will receive the Korean version of the 2-page Prepared New York: Disaster and Emergency Preparation pocket guide (NYC Emergency Management, n.d.) after data collection has been completed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Korean Household Emergency Preparedness Instrument (K-HEPI) Score

    The Korean Household Emergency Preparedness Instrument (K-HEPI) is an all-hazards, comprehensive, 51-question instrument used to ascertain if a respondent is prepared for disasters. Higher scores on the HEPI indicate higher levels of preparedness. Excluding the Access and Functional Needs (AFN) and Special Actions (SA) subscales that are not applicable to all respondents, the minimum score a participant could receive on the General Preparedness (GP) scale is 0 and the maximum score is 40 (1 point for each yes-response and 0 points for each no-response). There is support for face, content, and criterion validity of this instrument. The HEPI questions are objective and ask about what the respondent presently owns or does in a dichotomous format.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2022
  2. Study start13 Jul 2023
  3. Primary completion19 Jul 2024
  4. Study completion19 Jul 2024

Resources

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
Model description
This is a phase 1 feasibility study via a cluster randomized controlled trial.
Masking
Single blind
Who is masked
Participant
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05544578
Sponsor's protocol ID
2022-0542-Hunter
Status last verified
Oct 2023
First submitted
14 Sep 2022
Last updated
15 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences (2nd ed.). Lawrence Erlbaum Associates.

  • Cong, Z. & Chen, Z. (2022). How are Asian-Americans different from other races in disaster preparedness in the context of caregiving responsibilities and preparation information access?. Natural Hazards. https://doi.org/10.1007/s11069-022-05262-6

  • Feher Waltz, C., Strickland, O. L., & Lenz, E. R. (2010). Measurement in nursing and health research (4th edition). Springer Publishing Company.

  • Heagele TN, Adams LM, McNeill CC, Alfred DM. Validation and Revision of the Household Emergency Preparedness Instrument (HEPI) by a Pilot Study in the City University of New York. Disaster Med Public Health Prep. 2022 Mar 25;17:e126. doi: 10.1017/dmp.2022.35.

    PubMed 35332858
  • Heagele TN, McNeill CC, Adams LM, Alfred DM. Household Emergency Preparedness Instrument Development: A Delphi Study. Disaster Med Public Health Prep. 2022 Apr;16(2):570-582. doi: 10.1017/dmp.2020.292. Epub 2020 Nov 20.

    PubMed 33213596
  • Sperber AD. Translation and validation of study instruments for cross-cultural research. Gastroenterology. 2004 Jan;126(1 Suppl 1):S124-8. doi: 10.1053/j.gastro.2003.10.016.

    PubMed 14978648
  • Zheng G, Oksuzyan S, Hsu S, Cloud J, Jewell MP, Shah N, Smith LV, Frye D, Kuo T. Self-Reported Interest to Participate in a Health Survey if Different Amounts of Cash or Non-Monetary Incentive Types Were Offered. J Urban Health. 2018 Dec;95(6):837-849. doi: 10.1007/s11524-018-0237-7.

    PubMed 29654397

Questions about this trial

What is this clinical trial studying?

A study testing Nurses Taking On Readiness Measures (N- TORM) in people with Disaster and Vulnerable Populations, run by Hunter College of City University of New York at 1 site in United States.

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 5 inclusion and 4 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 15 Aug 2024. 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 United States. 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?

Korean Household Emergency Preparedness Instrument (K-HEPI) Score (time frame: through study completion, an average of 1 year). 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 NCT05544578, which also lists 7 linked publications.

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 15 Aug 2024.

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