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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

March 24, 2011
May 17, 2013
January 2010
February 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01329211 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers
Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Gastroparesis
Not Provided
  • Gastroparesis Patients
  • Gastroparesis Patients' Caregivers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
68
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01329211
693-2009
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Shahnaz Sultan, MD University of Florida
University of Florida
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP