GastroparesisNCT01329211
Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers
An observational study of Gastroparesis, run by University of Florida at 1 site in United States.
Trial summary
The project will involve conducting a Needs Assessment for Gastroparesis patients and their caregivers with the goal of identifying quality of life issues associated with this disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Feb 2013
- 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: The research plan involves reviewing patient records to identify potential subjects. Questionnaires will be distributed to gastroparesis patients and their caregivers during their visit to the GI clinic at the day of enrollment and at six-month intervals for a two-year follow-up period, after informed consent has been obtained. Patients and caregivers will also be recruited by telephone. Gastroparesis patients, who have an established patient-physician relationship with Dr. Sultan, will be contacted by telephone in order to inquire about their interest in participating in the study. The details of the study, including the questionnaires, risks, and potential benefits will be discussed over the phone. Then, if patients and/or their caregivers are willing to participate in the study, the informed consent forms and the questionnaires will be mailed to them with a posted envelope to be returned to Dr. Sultan by mail.
Who may be able to join
- Gastroparesis patients at the GI clinic of Shands Hospital at the University of Florida
- Caregivers to Gastroparesis patients at the GI clinic of Shands Hospital at the University of Florida
Who cannot join
- Inability to fill out the questionnaires by any cause
Trial locations and contacts
1 site in 1 country.
About this study
The project will involve conducting a Needs Assessment for Gastroparesis patients and their caregivers with the goal of identifying quality of life issues associated with this disease. Identifying these issues will ameliorate management and support systems for gastroparesis currently existent in the community and, hopefully, provide information for the establishment of more resources to assist the patients and their families.
Read the detailed description
This project will involve: a) distributing questionnaires to up to 200 participants (100 patients and 100 caregivers) at the Shands Gastrointestinal clinic and b) focus groups including patients, medical provider, and the clinic case manager. The questionnaires will provide information on the relative effect of gastroparesis on the quality of life of the patients and their caregivers. Assessment of this needs assessment will then help identify areas of potential resource improvement and mobilization to provide support for the patients and their family members.
- Conditions
- Gastroparesis
- Keywords
- Gastroparesis, Quality of Life
- Medical subject headings
- Gastroparesis
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 |
|---|---|---|
| Gastroparesis Patients | Not described | |
| Gastroparesis Patients' Caregivers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score in a Quality of life assessment Questionnaire
Measured: During the clinicial visit at the day of enrollment(Day 1)
Secondary outcomes (4)
Score in a Quality of life assessment Questionnaire
Measured: 1st follow-up, at 6 months from Date of enrollment
Score in a Quality of life assessment Questionnaire
Measured: 2nd follow-up, at 12 months from date of enrollment
Score in a Quality of life assessment Questionnaire
Measured: 3rd follow-up, at 18 months form date of enrollment
Score in a Quality of life assessment Questionnaire
Measured: 4th(last) follow-up, At 24 months form date of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2011 (estimated)
- Study startJan 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: PI left institution,replacement PI not able to do study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shahnaz Sultan, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329211
- Sponsor's protocol ID
- 693-2009
- Status last verified
- May 2013
- First submitted
- 24 Mar 2011
- Last updated
- 20 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers
- ClinicalTrials.gov ID
- NCT01329211
- Acronym / sponsor ID
- 693-2009
- Conditions
- Gastroparesis
- Keywords
- Gastroparesis, Quality of Life
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution,replacement PI not able to do study.
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 5 Apr 2011 (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 project will involve conducting a Needs Assessment for Gastroparesis patients and their caregivers with the goal of identifying quality of life issues associated with this disease. Identifying these issues will ameliorate management and support systems for gastroparesis currently existent in the community and, hopefully, provide information for the establishment of more resources to assist the patients and their families.
Detailed description
This project will involve: a) distributing questionnaires to up to 200 participants (100 patients and 100 caregivers) at the Shands Gastrointestinal clinic and b) focus groups including patients, medical provider, and the clinic case manager. The questionnaires will provide information on the relative effect of gastroparesis on the quality of life of the patients and their caregivers. Assessment of this needs assessment will then help identify areas of potential resource improvement and mobilization to provide support for the patients and their family members.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastroparesis Patients | – | – |
| Gastroparesis Patients' Caregivers | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The research plan involves reviewing patient records to identify potential subjects. Questionnaires will be distributed to gastroparesis patients and their caregivers during their visit to the GI clinic at the day of enrollment and at six-month intervals for a two-year follow-up period, after informed consent has been obtained. Patients and caregivers will also be recruited by telephone. Gastroparesis patients, who have an established patient-physician relationship with Dr. Sultan, will be contacted by telephone in order to inquire about their interest in participating in the study. The details of the study, including the questionnaires, risks, and potential benefits will be discussed over the phone. Then, if patients and/or their caregivers are willing to participate in the study, the informed consent forms and the questionnaires will be mailed to them with a posted envelope to be returned to Dr. Sultan by mail.
Key inclusion criteria (2 listed)
- Gastroparesis patients at the GI clinic of Shands Hospital at the University of Florida
- Caregivers to Gastroparesis patients at the GI clinic of Shands Hospital at the University of Florida
Key exclusion criteria (1 listed)
- Inability to fill out the questionnaires by any cause
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
Score in a Quality of life assessment Questionnaire
Time frame: During the clinicial visit at the day of enrollment(Day 1)
4 secondary outcomes
Score in a Quality of life assessment Questionnaire
Time frame: 1st follow-up, at 6 months from Date of enrollment
Score in a Quality of life assessment Questionnaire
Time frame: 2nd follow-up, at 12 months from date of enrollment
Score in a Quality of life assessment Questionnaire
Time frame: 3rd follow-up, at 18 months form date of enrollment
Score in a Quality of life assessment Questionnaire
Time frame: 4th(last) follow-up, At 24 months form date of enrollment
Results and safety
The study was stopped early (reason given: PI left institution,replacement PI not able to do study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 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.
Shahnaz Sultan, MD principal investigator
University of Florida
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 Gastroparesis, run by University of Florida 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 2 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: stopped early, as of the sponsor's last update on 20 May 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 was stopped early (reason given: PI left institution,replacement PI not able to do study.). 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?
Score in a Quality of life assessment Questionnaire (time frame: During the clinicial visit at the day of enrollment(Day 1)). 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 20 May 2013.