StressNCT04100629
Digital Support Intervention on Newly Licensed Nurses
A study testing digital support: text messages in people with Stress and Job Stress, run by Duquesne University at 4 sites in United States.
Trial summary
Brief Description of the Study: Text messages will be sent to participants and responses will be surveyed to ascertain if using a social, digital intervention can influence NLNs' (newly licensed nurses') stress, resiliency, perceived sense of social support, and/or the intention to stay at current jobs. Read more about this study
- Who is it for?
- Ages 19 to 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Job Stress
- What is being tested?
- digital support: text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 Dec 2019to 14 May 2020
- 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 19 to 37 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Pioneer Hospital
Brawley, California, 92227
El Centro Regional Medical Center
El Centro, California, 92243
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of California, San Diego
San Diego, California, 92093
About this study
Official title: 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
Brief Description of the Study: Text messages will be sent to participants and responses will be surveyed to ascertain if using a social, digital intervention can influence NLNs' (newly licensed nurses') stress, resiliency, perceived sense of social support, and/or the intention to stay at current jobs. Newly licensed nurses (within their first year of hire) will be asked to participate. 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. Participants will fill out surveys before the study begins, at week 3 and at the end of the study (week 6).The control group will receive medical facts. Texts sent to the experimental group will be based on SSBC nurturant support messages and are intended to decrease stress intention to leave (ITL), increase resilience, and perceived sense of support. The SSBC nurturant support texts are comprised of three themes of support: emotional, network, and esteem. The experimental group's supportive text messages were created by the PI and require content validation. A gatekeeper at your facility will be asked to send an email to "Experts" (MSN educators) and ask them to complete the validation survey using a Qualtrics Survey Platform then the PI will place ratings into a table and calculate the results. There are 3 other facilities enrolled in this study: University California, San Diego, El Centro Medical Center, and Pioneer Hospital (all located in southern California).
Read the 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.
- Conditions
- Stress, Job Stress
- Being tested
- digital support: text messages
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital support: text messagesBehavioural
Also called text messages
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | 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. Receives: Behavioral: digital support: text messages |
| Experimental Group | Experimental | 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. Receives: Behavioral: digital support: text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reported levels of perceived stress will change; predicted to decrease.
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.
Measured: prior to intervention, 3 weeks, and 6 weeks
Report levels of resiliency will change; predicted to increase.
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.
Measured: prior to intervention, 3 weeks, and 6 weeks
Reported levels of participants Sense of Support will change; predicted to increase.
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.
Measured: prior to intervention, 3 weeks, and 6 weeks
Intentions to Leave current job will change; predicted to decrease.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start13 Dec 2019
- Primary completion30 Apr 2020
- Study completion14 May 2020
Why it stopped: Lack of enrollment (and due to pandemic)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A prospective, RCT design with an experimental and control group is proposed for this study to determine if a digital support intervention impacts Newly Licensed Nurses' stress, resiliency, perceived sense of support, and Intention To Leave their current jobs.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Collaborators
- West Penn Allegheny Health System, University of California, San Diego, El Centro Medical Center, Pioneers Hospital
- Responsible party
- Principal investigator, Lisa A Concilio, Duquesne University
- Investigators
- David Delmonico, PhD, Study director, Chair of the Duquesne University IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100629
- Sponsor's protocol ID
- 2019/06/10
- Status last verified
- Jun 2020
- First submitted
- 19 Sep 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04100629
- Acronym / sponsor ID
- 2019/06/10
- Conditions
- Stress, Job Stress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment (and due to pandemic)
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Collaborators
- West Penn Allegheny Health System, University of California, San Diego, El Centro Medical Center, Pioneers Hospital
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brief Description of the Study: Text messages will be sent to participants and responses will be surveyed to ascertain if using a social, digital intervention can influence NLNs' (newly licensed nurses') stress, resiliency, perceived sense of social support, and/or the intention to stay at current jobs. Newly licensed nurses (within their first year of hire) will be asked to participate. 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. Participants will fill out surveys before the study begins, at week 3 and at the end of the study (week 6).The control group will receive medical facts. Texts sent to the experimental group will be based on SSBC nurturant support messages and are intended to decrease stress intention to leave (ITL), increase resilience, and perceived sense of support. The SSBC nurturant support texts are comprised of three themes of support: emotional, network, and esteem. The experimental group's supportive text messages were created by the PI and require content validation. A gatekeeper at your facility will be asked to send an email to "Experts" (MSN educators) and ask them to complete the validation survey using a Qualtrics Survey Platform then the PI will place ratings into a table and calculate the results. There are 3 other facilities enrolled in this study: University California, San Diego, El Centro Medical Center, and Pioneer Hospital (all located in southern California).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective, RCT design with an experimental and control group is proposed for this study to determine if a digital support intervention impacts Newly Licensed Nurses' stress, resiliency, perceived sense of support, and Intention To Leave their current jobs.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Behavioral: digital support: text messagesThe 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. |
| Experimental Group | Experimental | Behavioral: digital support: text messagesTexts 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. |
Who may qualify
- Ages
- 19 to 37 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital support: text messagesAlso: text messagesIn 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. | Behavioural | Control Group, Experimental Group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study was stopped early (reason given: Lack of enrollment (and due to pandemic)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Delmonico, PhD study director
Chair of the Duquesne University IRB
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital support: text messages in people with Stress and Job Stress, run by Duquesne University at 4 sites 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 11 inclusion and 3 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: stopped early, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Lack of enrollment (and due to pandemic)). Results are not available in the source record.
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?
Reported levels of perceived stress will change; predicted to decrease. (time frame: prior to intervention, 3 weeks, and 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2020.