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

Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01329211
• Other study ID #: 693-2009
• Status: Terminated
• Phase: N/A
• First received: March 24, 2011
• Last updated: May 17, 2013
• Start date: January 2010
• Est. completion date: February 2013

Study information

• Verified date: May 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroparesis

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score in a Quality of life assessment Questionnaire		During the clinicial visit at the day of enrollment(Day 1)	No
Secondary	Score in a Quality of life assessment Questionnaire		1st follow-up, at 6 months from Date of enrollment	No
Secondary	Score in a Quality of life assessment Questionnaire		2nd follow-up, at 12 months from date of enrollment	No
Secondary	Score in a Quality of life assessment Questionnaire		3rd follow-up, at 18 months form date of enrollment	No
Secondary	Score in a Quality of life assessment Questionnaire		4th(last) follow-up, At 24 months form date of enrollment	No