A Proactive Intervention Promoting Strategies for Sleep and Recovery in Nurses

January 28, 2020 updated by: Anna Dahlgren, Karolinska Institutet

Bädda för Kvalitet: Proaktiva Strategier för återhämtning i främjandet av hälsa Och Arbetsprestation.

Considering the known challenges facing newly graduated nurses, there are possibilities to implement preventive actions. The aim of the current study was to evaluate the effects of a preventive intervention among newly graduated nurses, supporting proactive strategies for sleep and recuperation in relation to work related stress and shift work.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 20% of all Swedish nurses experiences very high levels of burnout symptoms at some point during the first years of practice. Many factors are likely to be involved, and when developing methods to facilitate the nurse's transition from education into working life, a variety of stressors at both the organisational and individual level have to be considered. Previously, incomplete recovery has been suggested to mediate the relation between stressful working conditions and health impairment. For many, starting working as a nurse also means an introduction to shiftwork, which inevitably affects opportunities for sleep and recuperation due to interference with the circadian and homeostatic regulation of sleep. Given the vital role of sleep and recovery in the relationship between stress and development of impaired health, effective strategies for sleep and recuperation are hypothesised to be crucial in preventing the development of stress-related symptoms among nurses. In addition, lack of sleep and recuperation results in fatigue, which is a major safety hazard threatening patient safety. The aim of the current study was to evaluate a preventive intervention for new nurses, supporting strategies for sleep and recuperation in relation to work related stress and shift work.

Recruitment Newly graduated nurses were recruited at five Swedish hospitals. The recruitment was done via the introduction programmes, except from at one of the hospitals (which did not have such a programme) where the nurses instead were recruited via the different clinics. In total the intervention was implemented in eight different cohorts during 2017 and 2018. Approximately 462 newly graduated nurses were invited to participate in the study and 207 joined and answered the baseline questionnaire (45%).

Design The participants were randomly assigned to intervention and control groups. The participants were followed with questionnaires Participants were followed with either questionnaires or questionnaires + intesive measures using diary, actigraphy and cognitive tests. Questionnaires were filled in before the intervention (baseline), one month after the intervention (post), and at six months after the intervention (follow-up). The intensive measure was conducted at baseline and post intervention.

The participants also got a short questionnaire to fill out at the start of session two and three, and two weeks after session three, in which they filled out which strategies they had used during the last couple of weeks. After the last session, participants were asked to evaluate the intervention using a short questionnaire.

The intervention The intervention was a preventive programme focusing on beneficial strategies for sleep and recuperation in relation to work stress and shift work. The programme included three 2.5 hours-group sessions every second week. The sessions were taking place at work during working hours. The intervention was based on knowledge from research on sleep, stress and work hours, as well as on cognitive behavioural therapy (CBT) techniques for sleep and stress management modified for shift workers. The regulation of sleep and wakefulness was explained by the three factors: 1) circadian rhythm, 2) homeostatic process, and 3) stress, referred to as the sleep formula. How these factors interacts with irregular work hours was explained. Participants were encouraged to reflect on their daily habits related to sleep and recovery. Also, a CBT-model for analysing behaviours in stressful work situations were used in order to encourage participants to reflect on their usual behaviours and possible alternatives. As homework between sessions, the participants were encouraged to try possibly beneficial strategies for sleep and recuperation. The participants got written material, after every session, covering the content of the session. In addition, the participants got access to an adapted version of the biomathematical model (ArturNurse) to give participants an estimation of expected sleep lengths and fatigue levels together with tips of possible strategies to optimise sleep in relation to different shifts.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
207

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Göteborg, Sweden
        • Sahlgrenska Universitetssjukhuset
      • Huddinge, Sweden
        • Karolinska Universitetssjukhuset
      • Linköping, Sweden
        • Universitetssjukhuset
      • Ljungby, Sweden
        • Lasarettet Ljungby
      • Norrköping, Sweden
        • Vrinnevisjukhuset
      • Solna, Sweden
        • Karolinska Universitetssjukhuset
      • Växjö, Sweden
        • Centrallasarettet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newly graduated nurse in the first year of employment

No Exclusion Criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
The intervention group received a "Recovery programme" including three group sessions.
Behavioral: Bädda för Kvalitet
A group-administered preventive programme focusing on beneficial strategies for sleep and recuperation, in relation to work related stress and shift work. The intervention was based on knowledge from previous research on sleep, stress and work hours, as well as on cognitive behavioural therapy (CBT) techniques for sleep and stress management, modified for shift workers. Participants were encouraged to discuss and reflect on personal habits related to sleep and recovery. As homework between sessions, the participants were encouraged to try possibly beneficial strategies for sleep and recuperation. All participants got written material covering the content of the session, during each sessions. In addition, an adapted version of a biomathematical model ("ArturNurse") was used to give participants an estimation of expected sleep lengths and fatigue levels together with tips of possible strategies to optimise sleep in relation to different shifts.
No Intervention: Control group
The control group was on a waiting list to receive the intervention after the last follow-up measure (six months after the intervention group's last group session).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in insomnia symptoms (subjective measure)
Time Frame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Insomnia Severity Index (ISI) which consists of 7 questions related to sleep e.g. "How satisfied are you with your current sleep pattern?" (0 = very satisfied, 4 = very dissatisfied). The total score is summarised with a minimum score 0, maximum score 28. Higher scores indicate more sleep problems.
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Change in sleep quality (subjective measure)
Time Frame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Karolinska Sleep Questionnaire (KSQ) from which a sleep quality index was formed based on four questions e.g. "Have you had problems falling asleep the past month"? etc : Minimum score 1, maximum score 6. Lower scores indicate worse sleep quality.
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Change in Dysfunctional beliefs and attitudes about sleep (subjective measure)
Time Frame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Dysfunctional Beliefs and Attitudes about Sleep (DBAS) consists of 10 statements regarding beliefs and attitudes to sleep e.g. "I am concerned that chronic insomnia may have serious consequences on my physical health"; "When I have trouble sleeping, I should stay in bed and try harder" (strongly agree - strongly disagree): Minimum score 0, maximum score 10. Higher scores indicate more dysfunctional sleep-related cognitions.
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Change in sleep (subjective measure)
Time Frame: In order to detect change measures were made at baseline to 4 weeks after the intervention. Measured seven days at baseline and seven days at follow up.
Karolinska Sleep Diary (KSD). KSD includes bedtime; time of awakening; sleep latency (the time it takes to fall asleep); feelings of worry and stress at bedtime (1 very worried/aroused - 5 very calm/relaxed); and the following questions: Did you have difficulties falling asleep? (1 = very; 5 = not at all) How did you sleep? (1 = very badly; 5 = very good); Did you have a restless sleep? (1 = very much so; 5 = not at all); Did you wake up very early without being able to fall asleep? (1 = much too early; 5 = no). These four latter questions constitutes a sleep quality index, minimum score 1, maximum score 5: Lower scores indicate worse sleep quality.
In order to detect change measures were made at baseline to 4 weeks after the intervention. Measured seven days at baseline and seven days at follow up.
Change in satisfaction with sleep
Time Frame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Self-rated sufficient sleep (5=very insufficient 1=fully sufficient)
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Change in subjective sleep quality
Time Frame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Self-rated general sleep quality (1=very good 5=very bad).
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Change in sleep (objective measures)
Time Frame: In order to detect change measures were made at baseline and at 4 weeks after the intervention. Measured seven days at baseline and seven days at follow up.

Actigraphy (wrist-watch). Measuring of movements during sleep through a sensitive accelerometer in the wrist-watch. The value, which is described as the amount of movements per minute, is saved in the memory of the actigraph. Preprogrammed algorithms make it possible to classify if the participant has slept or not. Measured seven nights at baseline and seven nights at follow up. Example of measures:

Actual sleep time: The total time spent in sleep according to the epoch-by-epoch wake/sleep categorisation.

Actual sleep %: Actual sleep time expressed as a percentage of the assumed sleep time.

Actual wake time: The total time spent in wake according to the epoch-by-epoch wake/sleep categorisation.

Wake bouts: The number of contiguous sections categorised as wake in the epoch-by- epoch wake/sleep categorisation.

Sleep fragmentation: The sum of the "Mobile time (%)" and the "Immobile bouts <=1min (%)". This is an indication of the degree of fragmentation.
In order to detect change measures were made at baseline and at 4 weeks after the intervention. Measured seven days at baseline and seven days at follow up.
Change in work home interference (subjective measures)
Time Frame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Work-Home Interference (WHI) measured with four items: "I come home from work too tired to do things I would like to do."; "My job makes it difficult to maintain the kind of personal life I would like."; "I often neglect my personal needs because of the demands of my work."; "My personal life suffers because of my work." Rated on a 5-graded scale ranging from 1=not at all to 5=almost always.
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Change in fatigue and recuperation (subjective measures)
Time Frame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Single items (self-ratings): Frequency of recovery behaviours (e.g. micro breaks (1 = every shift, 5 = Never); routine for winding down before bedtime (1 = never, 5 = Always); Satisfaction regarding rest and recuperation during spare time (1 = fully sufficient, 5 = no, far from sufficient); Use of strategies for optimizing sleep and recuperation (1 = never, 5= always); General satisfaction with spare time (1 = very good, 5 = very bad); Use of free time before evening shifts (1 = never, 5 = always); Frequency of breaks during work shifts (1 = every shift, 5= never).
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Change in diurnal levels of sleepiness (subjective measures)
Time Frame: In order to detect change measures were made at baseline and 4 weeks after the intervention.
Karolinska Sleepiness Scale (KSS): A nine-graded scale with values ranging from 1=very alert to 9=very sleepy, fighting sleep. Measured every third hour during wake time seven days at baseline and seven days at follow up.
In order to detect change measures were made at baseline and 4 weeks after the intervention.
Change in symptoms of sleepiness and fatigue (subjective measures)
Time Frame: In order to detect change measures were made at baseline to 4 weeks after the intervention.
Single items measuring symptoms of fatigue e.g. "sustained fatigue", "unfocused" and "engaged", on a five-graded scale ranging from 1=not at all, and 5=very much. Measured seven days at baseline and seven days at follow up.
In order to detect change measures were made at baseline to 4 weeks after the intervention.
Change in burnout (subjective measure)
Time Frame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Shirom-Melamed Burnout Questionnaire (SMBQ): Minimum score 1, maximum score 7. Higher scores indicate more burnout.
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Change in perceived stress (subjective measure)
Time Frame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Perceived Stress Scale (PSS-10) which consists of 10 statements e.g.. "In the last month, how often have you felt nervous and "stressed"; "In the last month, how often have you found that you could not cope with all the things that you had to do"? etc: Answers on 0 = never, 4 = very often. These are summarised. Minimum score 0, maximum score 40. Higher scores indicate more stress.
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Change in stress and energy (subjective measures)
Time Frame: In order to detect change measures were made at baseline and 4 weeks after the intervention.
Stress-Energy rating questionnaire: Minimum score 0, maximum score 5. Higher scores indicate more stress and more energy.
In order to detect change measures were made at baseline and 4 weeks after the intervention.
Change in stress symptoms (subjective measures)
Time Frame: In order to detect change measures were made at baseline and 4 weeks after the intervention.
Self-ratings of stress symptoms/absence of stress symptoms (single items): "Tense"; "Irritated"; "Exhausted"; "Hard to disconnect from thoughts of work during spare time"; "Emotional burden"; "Relaxed/calm" on a scale ranging from 1=not at all, and 5=very much. Measured every day during seven days at baseline and seven days at follow up.
In order to detect change measures were made at baseline and 4 weeks after the intervention.
Change in diurnal levels of stress (subjective measures)
Time Frame: In order to detect change measures were made at baseline and 4 weeks after the intervention.
Self-rated stress scale for repeated measurement, measured one a nine-graded scale with values ranging from 1=very low stress to 9=very high stress. Measured every third hour during wake time seven days at baseline and seven days at follow up.
In order to detect change measures were made at baseline and 4 weeks after the intervention.
Change in stress (objective measures)
Time Frame: In order to detect change measures were made at baseline and 4 weeks after the intervention.
Hair cortisol based on 2 cm segments (pg/mg)
In order to detect change measures were made at baseline and 4 weeks after the intervention.
Change in somatic symptoms
Time Frame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Somatic Symptoms Scale-8 (SSS-8): Minimum score 0, maximum score 32. Higher scores indicate higher somatic symptom burden.
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Change in health
Time Frame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Single items: Self-rated health on a scale ranging from 1=very good to 7=very bad. Self-rated use of medical drugs the past three months (frequency as 1 = never, 5 = always), coffee consumption during a work day (1 = none, 5 = 7 cups or more); how often do you do 30 minutes of physical exercise (1 = never, 5 = 3 times of more/week).
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Change in psychological health
Time Frame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Single items (self-ratings): How often have you during the past 7 days felt "depressed"; "stated"; "sad"; "worried"; "nervous"; "unsure" on a scale ranging from 0=not at all to 5=very much.
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Change in self rated health
Time Frame: In order to detect change measures were made at baseline and 4 weeks after the intervention.
Self-rated health on a scale ranging from 1=very good to 7=very bad. Measured daily during seven days at baseline and seven days at follow-up.
In order to detect change measures were made at baseline and 4 weeks after the intervention.
Change in performance and cognitive symptoms (subjective measures)
Time Frame: In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Ratings (single items): Self-rated work performance through the following items: During the past month how often have you during you work .... "in risk of mistakes"; "found it hard to make decisions"; "been present during interaction with others"; "had to make corrections or double-check work tasks" (1 = never, 5 = Always). Sub-indices from SMBQ (described above) will also be used as measures of cognitive symptoms.
In order to detect change measures were made at baseline, 4 weeks after the intervention and 6 months after the intervention.
Change in performance and cognitive symptoms (subjective measures)
Time Frame: In order to detect change measures were made at baseline and 4 weeks after the intervention. Measured seven days at baseline and seven days at follow up.
Self-ratings (single items) of how well the participant managed to (at work) make decisions; keep things in their head; keep track of the overall picture; perform tasks in a safe way; being present during interaction with others. Rated on a 5-graded scale ranging from 1=very well to 5=very badly.
In order to detect change measures were made at baseline and 4 weeks after the intervention. Measured seven days at baseline and seven days at follow up.
Change in performance, arithmetic ability (objective measures)
Time Frame: In order to detect change tests were made at baseline (one day, during and after work) and 4 weeks after the intervention (one day, during and after work).
Cognitive tests measuring executive functioning, performed on the participant's mobile phone. In the arithmetic ability task, the participant is presented with simple arithmetical addition questions and required to calculate the answer and type it into the phone. New questions are presented until the time is running out (duration 2 minutes). Performance is measured in terms of total score (correct responses during 2 minutes) and the speed of correct responses (in ms).
In order to detect change tests were made at baseline (one day, during and after work) and 4 weeks after the intervention (one day, during and after work).
Change in performance, episodic memory (objective measures)
Time Frame: In order to detect change tests were made at baseline (one day, during and after work) and 4 weeks after the intervention (one day, during and after work).
Cognitive tests measuring executive functioning, performed on the participant's mobile phone. In the episodic memory task, participants are presented with a list of 12 words for 12 seconds, which they are asked to remember. A fixation cross then appears for 5 seconds. Following this, participants are shown a list of 24 words, which contains the original 12 words, and an additional 12 dummy words, and are asked whether each word was previously shown (yes/no). The task is performed twice. Performance is assessed as percentage correct.
In order to detect change tests were made at baseline (one day, during and after work) and 4 weeks after the intervention (one day, during and after work).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in work measures
Time Frame: Baseline, 4 weeks after the intervention and 6 months after the intervention.
Single items (self-ratings): Satisfaction with work; Work environment ratings (e.g. tempo, emotional demands, control over work tasks, support, engagement, frequency of tasks in conflict with personal values, quality of cooperation with coworkers); Self-rated patient safety at workplace; Work time control (WTC) where the respondents rate on a five graded scale (1=very little to 5=very much) how much they are able to influence the following aspects of their working times: length of a work shift, the starting and ending times of a work shift, the taking of breaks during the work shift, the scheduling of work shifts, the scheduling of vacations and days off, and the handling of private matters during the workday
Baseline, 4 weeks after the intervention and 6 months after the intervention.
Changes in working hours
Time Frame: Baseline, 4 weeks after the intervention and 6 months after the intervention.

Single items (self-ratings):

Frequency (per month) of overtime work, night shifts and quick returns (less than 11 hours between shifts). Self-rated experiences of problems regarding these different type of shifts/shift combinations (yes/no), type of shift schedule, satisfaction with working hours (1 = very bad, 5 = very good).
Baseline, 4 weeks after the intervention and 6 months after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AFA Insurance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AFA:150024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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