Information RetentionNCT00604240
Telephone Follow-up From an Intensive Care Nursery
An observational study of Information Retention, run by Christiana Care Health Services at 2 sites in United States.
Trial summary
The first few weeks after leaving the Neonatal Intensive Care Unit (NICU) can be a difficult transition time for caregivers of a previously hospitalized infant. To help ease this stressful period, doctors and nurses give caregivers a large amount of information prior to their infant leaving the NCIU. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Information Retention
- How many people
- 175 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2007to Dec 2008
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Parents/caregivers of infants who are hospitalized in the NICU
Who may be able to join
- Parents/caregivers of infants who have spent one week or longer in the NICU at Christiana Hospital or Thomas Jefferson University Hospital.
Who cannot join
- Parents / caregivers of infants who have spent less than one week in the NICU at Christiana Hospital or Thomas Jefferson University Hospital.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Christiana Hospital
Newark, Delaware, 19711
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Telephone Follow-up From an Intensive Care Nursery: What do Parents Actually Remember?
The first few weeks after leaving the Neonatal Intensive Care Unit (NICU) can be a difficult transition time for caregivers of a previously hospitalized infant. To help ease this stressful period, doctors and nurses give caregivers a large amount of information prior to their infant leaving the NCIU. How much caregivers remember about medications, follow-up appointments, and general well-child care has not been studied. Caregivers who choose to participate will receive a phone call 2-7 days after discharge where they will be asked questions pertaining to the information that was discussed with them at the time of discharge. The purpose of the study is to determine how much information caregivers retain after leaving the NICU.
- Conditions
- Information Retention
- Keywords
- NICU, caregivers, discharge instructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Parents / caregivers of any infant who has a length of stay of at least 1 week in the NICU at Christiana Hospital or Thomas Jefferson University Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of information that parents / caregivers are able to retain
Measured: Within one week after the infant is discharged from the NICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Information RetentionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University
- Responsible party
- Sponsor
- Investigators
- Constance Andrejko, DO, Principal investigator, Christiana Hospital and Thomas Jefferson University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604240
- Sponsor's protocol ID
- 27164
- Status last verified
- May 2017
- First submitted
- 17 Jan 2008
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Follow-up From an Intensive Care Nursery: What do Parents Actually Remember?
- ClinicalTrials.gov ID
- NCT00604240
- Acronym / sponsor ID
- 27164
- Conditions
- Information Retention
- Keywords
- NICU, caregivers, discharge instructions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- Thomas Jefferson University
- Study start
- Nov 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Jan 2008 (estimated)
- 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.
The first few weeks after leaving the Neonatal Intensive Care Unit (NICU) can be a difficult transition time for caregivers of a previously hospitalized infant. To help ease this stressful period, doctors and nurses give caregivers a large amount of information prior to their infant leaving the NCIU. How much caregivers remember about medications, follow-up appointments, and general well-child care has not been studied. Caregivers who choose to participate will receive a phone call 2-7 days after discharge where they will be asked questions pertaining to the information that was discussed with them at the time of discharge. The purpose of the study is to determine how much information caregivers retain after leaving the NICU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Parents / caregivers of any infant who has a length of stay of at least 1 week in the NICU at Christiana Hospital or Thomas Jefferson University Hospital. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents/caregivers of infants who are hospitalized in the NICU
Key inclusion criteria (1 listed)
- Parents/caregivers of infants who have spent one week or longer in the NICU at Christiana Hospital or Thomas Jefferson University Hospital.
Key exclusion criteria (1 listed)
- Parents / caregivers of infants who have spent less than one week in the NICU at Christiana Hospital or Thomas Jefferson University Hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Amount of information that parents / caregivers are able to retain
Time frame: Within one week after the infant is discharged from the NICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
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.
Constance Andrejko, DO principal investigator
Christiana Hospital and Thomas Jefferson University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Information Retention, run by Christiana Care Health Services at 2 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 1 inclusion and 1 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 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Amount of information that parents / caregivers are able to retain (time frame: Within one week after the infant is discharged from the NICU). 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 10 May 2017.