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

Sponsor
University of Florida (Other)
Overall Status
Terminated
CT.gov ID
NCT01329211
Collaborator
(none)
68
Enrollment
1
Location
37
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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 or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    68 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers
    Study Start Date :
    Jan 1, 2010
    Actual Primary Completion Date :
    Feb 1, 2013
    Actual Study Completion Date :
    Feb 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Gastroparesis Patients
    Gastroparesis Patients' Caregivers

    Outcome Measures

    Primary Outcome Measures

    1. Score in a Quality of life assessment Questionnaire [During the clinicial visit at the day of enrollment(Day 1)]

    Secondary Outcome Measures

    1. Score in a Quality of life assessment Questionnaire [1st follow-up, at 6 months from Date of enrollment]

    2. Score in a Quality of life assessment Questionnaire [2nd follow-up, at 12 months from date of enrollment]

    3. Score in a Quality of life assessment Questionnaire [3rd follow-up, at 18 months form date of enrollment]

    4. Score in a Quality of life assessment Questionnaire [4th(last) follow-up, At 24 months form date of enrollment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 University of Florida Gainesville Florida United States 32611

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: Shahnaz Sultan, MD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT01329211
    Other Study ID Numbers:
    • 693-2009
    First Posted:
    Apr 5, 2011
    Last Update Posted:
    May 20, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by University of Florida
    Gastroparesis
    Quality of Life
    Additional relevant MeSH terms:
    Gastroparesis

    Study Results

    No Results Posted as of May 20, 2013