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

NCT01329211 | Terminated

• 1 other identifier: 693-2009
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroparesis

Keywords

Gastroparesis; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Score in a Quality of life assessment Questionnaire

  During the clinicial visit at the day of enrollment(Day 1)

Secondary Outcomes (4)

• Score in a Quality of life assessment Questionnaire

  1st follow-up, at 6 months from Date of enrollment

• Score in a Quality of life assessment Questionnaire

  2nd follow-up, at 12 months from date of enrollment

• Score in a Quality of life assessment Questionnaire

  3rd follow-up, at 18 months form date of enrollment

• Score in a Quality of life assessment Questionnaire

  4th(last) follow-up, At 24 months form date of enrollment

Study Arms (2)

Gastroparesis Patients

Gastroparesis Patients' Caregivers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Inability to fill out the questionnaires by any cause

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shahnaz Sultan, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: April 5, 2011
• Study Start: January 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 20, 2013

Record last verified: 2013-05

Locations

US (1)