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Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers

This study has been terminated.
(PI left institution,replacement PI not able to do study.)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01329211
First received: March 24, 2011
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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.


Condition
Gastroparesis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Score in a Quality of life assessment Questionnaire [ Time Frame: During the clinicial visit at the day of enrollment(Day 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Score in a Quality of life assessment Questionnaire [ Time Frame: 1st follow-up, at 6 months from Date of enrollment ] [ Designated as safety issue: No ]
  • Score in a Quality of life assessment Questionnaire [ Time Frame: 2nd follow-up, at 12 months from date of enrollment ] [ Designated as safety issue: No ]
  • Score in a Quality of life assessment Questionnaire [ Time Frame: 3rd follow-up, at 18 months form date of enrollment ] [ Designated as safety issue: No ]
  • Score in a Quality of life assessment Questionnaire [ Time Frame: 4th(last) follow-up, At 24 months form date of enrollment ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: January 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gastroparesis Patients
Gastroparesis Patients' Caregivers

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Inability to fill out the questionnaires by any cause
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01329211

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Shahnaz Sultan, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01329211     History of Changes
Other Study ID Numbers: 693-2009
Study First Received: March 24, 2011
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Gastroparesis
Quality of Life

Additional relevant MeSH terms:
Gastroparesis
Digestive System Diseases
Gastrointestinal Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms
Stomach Diseases

ClinicalTrials.gov processed this record on November 20, 2014