Sickle Cell DiseaseNCT01058473
Psychometric Evaluation of the IPPAQ in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain
An observational study of Sickle Cell Disease and Pain, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
Historically, sickle cell disease has not been viewed in the chronic pain paradigm because of its recurrent nature. Patients with sickle cell disease may be hospitalized for extended periods of time. Read more about this study
- Who is it for?
- Ages 7 to 21 years
- Conditions the study is for
- Sickle Cell Disease, Pain
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2012
- 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 7 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children, adolescents, and young adults with sickle cell disease.
Who may be able to join
- Documented sickle cell disease
- Sudden onset of pain consistent with vasoocclusive episode at the time of hospitalization.
- Pain requiring hospitalization and placement on standard clinical guideline for management of acute pain in sickle cell disease during hospitalization
- Cognitive ability to report pain on a 0-10 Numerical Rating Scale (NRS)
- Parental/patient consent and child assent
Who cannot join
- Primary diagnosis other than vasoocclusive pain
- Concurrent Acute Chest Syndrome (ACS)
- Patient previously enrolled in this study
- Inability to understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
Official title: Psychometric Evaluation of the Inpatient Pediatric Physical Activity Questionnaire (IPPAQ) in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain
Historically, sickle cell disease has not been viewed in the chronic pain paradigm because of its recurrent nature. Patients with sickle cell disease may be hospitalized for extended periods of time. As the hospital stay progresses, patients with SCD pain are often observed by clinicians to have improvements in function in areas such as self-care, mobility, and recreation despite continued self-report of high pain scores. This pattern of functional improvement with continued report of high pain intensity scores is common in patients with recurrent and chronic pain. A functional assessment tool that can assess function in the acute inpatient setting is needed.
The purpose of this study is to evaluate the Inpatient Pediatric Physical Activity Questionnaire (IPPAQ), as a measure of daily function in children with sickle cell disease hospitalized with vasoocclusive pain.
Read the detailed description
Refer to Brief Summary
- Conditions
- Sickle Cell Disease, Pain
- Keywords
- Sickle Cell Disease, Pain, Assessment
- Medical subject headings
- Anemia, Sickle Cell, Pain
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 |
|---|---|---|
| Sickle Cell Disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPPAQ
This is a functional assessment tool for pediatric sickle cell patients that is admisistered once a day.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Zempsky, MD, Connecticut Children's Medical Center
- Investigators
- William T. Zempsky, M.D., Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058473
- Sponsor's protocol ID
- CCMC IRB Number 09-115
- Status last verified
- Jul 2013
- First submitted
- 26 Jan 2010
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Evaluation of the Inpatient Pediatric Physical Activity Questionnaire (IPPAQ) in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain
- ClinicalTrials.gov ID
- NCT01058473
- Acronym / sponsor ID
- CCMC IRB Number 09-115
- Conditions
- Sickle Cell Disease, Pain
- Keywords
- Sickle Cell Disease, Pain, Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jan 2010 (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.
Historically, sickle cell disease has not been viewed in the chronic pain paradigm because of its recurrent nature. Patients with sickle cell disease may be hospitalized for extended periods of time. As the hospital stay progresses, patients with SCD pain are often observed by clinicians to have improvements in function in areas such as self-care, mobility, and recreation despite continued self-report of high pain scores. This pattern of functional improvement with continued report of high pain intensity scores is common in patients with recurrent and chronic pain. A functional assessment tool that can assess function in the acute inpatient setting is needed.
The purpose of this study is to evaluate the Inpatient Pediatric Physical Activity Questionnaire (IPPAQ), as a measure of daily function in children with sickle cell disease hospitalized with vasoocclusive pain.
Detailed description
Refer to Brief Summary
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sickle Cell Disease | – | – |
Who may qualify
- Ages
- 7 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children, adolescents, and young adults with sickle cell disease.
Key inclusion criteria (5 listed)
- Documented sickle cell disease
- Sudden onset of pain consistent with vasoocclusive episode at the time of hospitalization.
- Pain requiring hospitalization and placement on standard clinical guideline for management of acute pain in sickle cell disease during hospitalization
- Cognitive ability to report pain on a 0-10 Numerical Rating Scale (NRS)
- Parental/patient consent and child assent
Key exclusion criteria (4 listed)
- Primary diagnosis other than vasoocclusive pain
- Concurrent Acute Chest Syndrome (ACS)
- Patient previously enrolled in this study
- Inability to understand English
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
IPPAQ
Time frame: 1 day
This is a functional assessment tool for pediatric sickle cell patients that is admisistered once a day.
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 30 Jul 2013.
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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.
William T. Zempsky, M.D. principal investigator
Connecticut Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Pain, run by Connecticut Children's Medical Center 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 30 Jul 2013. 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?
IPPAQ (time frame: 1 day). 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 30 Jul 2013.