Type 1 Diabetes MellitusNCT00450489
Assessment of Quality of Life and Satisfaction With Medical Care of Pediatric Type 1 Diabetes Mellitus Patients
An observational study of Type 1 Diabetes Mellitus, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the change score for the PedsQL short form Diabetes and Core Modules and the Patient Assessment of Chronic Illness Care measured at baseline (before changing care delivery models) and 12 months after transitioning to the team model of care delivery. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2009
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children cared for Type 1 Diabetes Mellitus, in Children's Mercy Hospital and Clinics, Endocrine Clinic.
Who may be able to join
- Type 1 Diabetes Mellitus six years of age and older who are receiving care in the diabetic clinic at Children's Mercy Hospital
Who cannot join
- T1 Diabetes Mellitus patients not receiving care in the diabetes clinic at Children's Mercy Hospital or not meeting the age requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
The purpose of this study is to evaluate the change score for the PedsQL short form Diabetes and Core Modules and the Patient Assessment of Chronic Illness Care measured at baseline (before changing care delivery models) and 12 months after transitioning to the team model of care delivery.
Read the detailed description
Pediatric Type 1 Diabetes Mellitus patients and their parents will complete the forms before and 12 months after the diabetes clinic at Children's Mercy Hospital in Kansas City, MO transitions to a team model of care delivery.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, Quality of Life, Satisfaction of medical care delivery
- Medical subject headings
- Diabetes Mellitus, Type 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study startJun 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Investigators
- Kurt Midyett, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450489
- Sponsor's protocol ID
- 07 02-030E
- Status last verified
- Mar 2010
- First submitted
- 20 Mar 2007
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life and Satisfaction With Medical Care of Pediatric Type 1 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT00450489
- Acronym / sponsor ID
- 07 02-030E
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, Quality of Life, Satisfaction of medical care delivery
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 22 Mar 2007 (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 purpose of this study is to evaluate the change score for the PedsQL short form Diabetes and Core Modules and the Patient Assessment of Chronic Illness Care measured at baseline (before changing care delivery models) and 12 months after transitioning to the team model of care delivery.
Detailed description
Pediatric Type 1 Diabetes Mellitus patients and their parents will complete the forms before and 12 months after the diabetes clinic at Children's Mercy Hospital in Kansas City, MO transitions to a team model of care delivery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children cared for Type 1 Diabetes Mellitus, in Children's Mercy Hospital and Clinics, Endocrine Clinic.
Key inclusion criteria (1 listed)
- Type 1 Diabetes Mellitus six years of age and older who are receiving care in the diabetic clinic at Children's Mercy Hospital
Key exclusion criteria (1 listed)
- T1 Diabetes Mellitus patients not receiving care in the diabetes clinic at Children's Mercy Hospital or not meeting the age requirements
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
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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.
Kurt Midyett, MD principal investigator
Children's Mercy Hospital Kansas City
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 Type 1 Diabetes Mellitus, run by Children's Mercy Hospital Kansas City 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 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: withdrawn, as of the sponsor's last update on 16 Dec 2020. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 16 Dec 2020.