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

May 17, 2013 updated by: University of Florida
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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Gastroparesis Patients
Gastroparesis Patients' Caregivers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score in a Quality of life assessment Questionnaire
Time Frame: During the clinicial visit at the day of enrollment(Day 1)
During the clinicial visit at the day of enrollment(Day 1)

Secondary Outcome Measures

Outcome Measure
Time Frame
Score in a Quality of life assessment Questionnaire
Time Frame: 1st follow-up, at 6 months from Date of enrollment
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
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
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
4th(last) follow-up, At 24 months form date of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 24, 2011

First Submitted That Met QC Criteria

April 1, 2011

First Posted (Estimate)

April 5, 2011

Study Record Updates

Last Update Posted (Estimate)

May 20, 2013

Last Update Submitted That Met QC Criteria

May 17, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 693-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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