- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04100629
Digital Support Intervention on Newly Licensed Nurses
The Impact of a Digital Support Intervention on Stress, Resiliency, Perceived Social Support, and Intention to Leave Among Newly Licensed Nurses: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this randomized control study (RCT) is to determine the impact of a 6-week digital support intervention (text messaging) on NLNs' levels of stress, resiliency, perceived social support, and ITL (intention to leave) their current jobs. The long-term objective is to examine if a 6-week digital support intervention impacts NLNs' (newly licensed nurses') ITL during the first year of hire. The central hypothesis is that a digital support intervention plays a critical role in NLNs' levels of stress, resilience, perceived sense of social support, and ITL their current jobs. In order to be included in this proposed study, participants must agree to not use their Smartphones while providing direct patient care but may access text messages while in designated break areas or when off duty.
Research Questions: RQ1: What is the effect of a digital support intervention upon NLNs' stress? RQ2: What is the effect of a digital support intervention upon NLNs' resiliency? RQ3: What is the effect of a digital support intervention upon NLNs' perceived social support? RQ4: What is the effect of a digital support intervention upon NLNs' ITL their first jobs during their first year of hire?
Design (Description of research plan, intervention(s) and time frame): A prospective, RCT design with an experimental and control group is proposed for this study to determine if a digital support intervention impacts NLNs' stress, resiliency, perceived sense of support, and Intention to Leave.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Brawley, California, United States, 92227
- Pioneer Hospital
-
El Centro, California, United States, 92243
- El Centro Regional Medical Center
-
San Diego, California, United States, 92093
- University of California, San Diego
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15212
- Allegheny General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Newly Licensed Nurses,
- ages 19-37 years,
- proficient in English,
- working in an acute care facility as a RN during the first year of hire,
- have a working personal Smartphone,
- have the ability to send and receive text messages,
- have an active and working personal email account, and
- be willing to participate for six weeks,
- complete a demographic survey before the study, survey instruments at 3 weeks, 6 weeks, and at the conclusion of the study
- agree to not use or carry their Smartphone while performing direct patient care and
- assume any data charges for text messages, if incurred.
Exclusion Criteria:
- Newly Licensed Nurses who have worked in the role of a RN on another floor or
- NLNs who have worked as an RN at another organization, or
- NLNs not 19-37 years of age.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control Group
The control group will receive medical facts and are not meant to support newly licensed nurses and are not known to affect stress, resilience, perceived social support, or Intention To Leave one's job.
|
In this study, the text messages are intended to be one-directional, from the PI to the participant.
Participants are not expected to reply.
If participants reply to any of the text messages, the PI will screen the content and only reply if it is a question regarding the study or a request to seek counseling.
Additionally, participants will be instructed by the PI to access their Smartphones to read texts while on a break, after their shift, or when not at work; participants will be instructed to not use Smartphones to read texts while working.
A series of four text messages will be sent to all study participants (experimental and control groups) by the PI every Monday, Wednesday, Friday, and Saturday (M, W, F, S) at 1pm for six weeks, for a total of 24 different texts for each group.
Other Names:
|
Experimental: Experimental Group
Texts sent to the experimental group will be based on nurturant support messages and are intended to decrease stress, Intention To Leave, increase resilience, and perceived sense of support.
|
In this study, the text messages are intended to be one-directional, from the PI to the participant.
Participants are not expected to reply.
If participants reply to any of the text messages, the PI will screen the content and only reply if it is a question regarding the study or a request to seek counseling.
Additionally, participants will be instructed by the PI to access their Smartphones to read texts while on a break, after their shift, or when not at work; participants will be instructed to not use Smartphones to read texts while working.
A series of four text messages will be sent to all study participants (experimental and control groups) by the PI every Monday, Wednesday, Friday, and Saturday (M, W, F, S) at 1pm for six weeks, for a total of 24 different texts for each group.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reported levels of perceived stress will change; predicted to decrease.
Time Frame: prior to intervention, 3 weeks, and 6 weeks
|
The Perceived Stress Scale (PSS) will be used to measure stress (Cohen, Kamarck, & Mermelstein, 1983).
Participant stress will measured prior to intervention, at 3 weeks, and 6 weeks.
It is a 10-item, Likert-type scale with five points.
Scores are obtained by using the item responses that range from 0 to 4 (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often) with items 4, 5, 7, and 8 reversely scored.
The summed scores of the PSS will be used for one of the dependent variables and will be discussed further as a key variable.
Participants will be asked to think about their current work situation when answering survey questions.
The possible range of scores, after adding all points, will range from 0 to 40, with higher scores signifying greater perceived stress.
|
prior to intervention, 3 weeks, and 6 weeks
|
Report levels of resiliency will change; predicted to increase.
Time Frame: prior to intervention, 3 weeks, and 6 weeks
|
The Connor-Davidson Resiliency Scale (CD-RISC-25) will be used to measure resiliency (Connor & Davidson, 2003).
Participant resilience will measured prior to intervention, at 3 weeks, and 6 weeks.
The CD-RISC-25 is a 25-item self-report scale that uses a five-point Likert-type scale ranging from 0 (not true at all) to 4 (true nearly all the time).
Total scores, ranging from 0-100, assess resilience and a score of 100 denotes the highest level of resiliency; the tool takes 5-10 minutes to complete (CD RISC, 2011).
The summed scores of the CD-RISC 25 will be used for one of the dependent variables and will be discussed further as a key variable.
|
prior to intervention, 3 weeks, and 6 weeks
|
Reported levels of participants Sense of Support will change; predicted to increase.
Time Frame: prior to intervention, 3 weeks, and 6 weeks
|
The Social Support Scale (SSS) will be used to measure perceived social support scores (Dolbier & Steinhardt, 2000).
Participant perceived social support will measured prior to intervention, at 3 weeks, and 6 weeks.
Respondents answer 21 items on a 4-option Likert-type scale labeled between 0 (not true at all) to 3 (completely true) (Dolbier & Steinhardt, 2000) and will take 20-25 minutes to complete (Versta, 2011).
The summed scores of the SSS will be used for one of the dependent variables and will be discussed further as a key variable.
|
prior to intervention, 3 weeks, and 6 weeks
|
Intentions to Leave current job will change; predicted to decrease.
Time Frame: 6 weeks
|
An "Intention to Leave," investigator designed survey will be used to measure the participants' Intention to Leave their current jobs.
Participant intention to leave their current job will measured at 6 weeks.
Participants will be asked what percentage, if any, represents their ITL their current position and also what percentage represents their ITL to leave their current organization.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: David Delmonico, PhD, Chair of the Duquesne University IRB
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/06/10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
University of Sao PauloCompleted
-
Dana-Farber Cancer InstituteEnrolling by invitationStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
Syracuse VA Medical CenterUS Department of Veterans AffairsCompletedEmotional Stress | Psychological Stress | Life StressUnited States
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
Northumbria UniversityVolac International LtdNot yet recruitingStress | Mood | Physiological Stress
-
Taichung Veterans General HospitalUnknown
-
Oslo University HospitalSykehuset Ostfold; Betanien HospitalTerminatedStress Fracture Foot | Stress Fracture AnkleNorway
Clinical Trials on digital support: text messages
-
Duke UniversityNational Cancer Institute (NCI)CompletedSmoking | PregnancyUnited States
-
Environment and Health Group, Inc.CompletedHypertensionUnited States
-
University of Wisconsin, MadisonThrive FoundationRecruiting
-
University of Colorado, DenverNational Heart, Lung, and Blood Institute (NHLBI)RecruitingCardiovascular Diseases | Lifestyle FactorsUnited States
-
The Miriam HospitalLive Inspired, LLCCompletedSmoking CessationUnited States
-
Monash UniversityNovartis PharmaceuticalsRecruitingCerebrovascular Disease | Coronary Heart Disease (CHD) | Peripheral Arterial Disease (PAD) | Atherosclerotic Cardiovascular Disease (ASCVD)Australia
-
Friedrich-Alexander-Universität Erlangen-NürnbergPhilipps University Marburg Medical CenterCompleted
-
Children's Hospitals and Clinics of MinnesotaHealthPartners InstituteUnknownAsthmaUnited States
-
Medical University of South CarolinaRoswell Park Cancer InstituteCompleted
-
Auburn UniversityCompleted