Clinical trial NCT01329211: Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers
Official title: Needs Assessment Evaluating Quality of Life Issues for Gastroparesis Patients and Caregivers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Gastroparesis
Keywords: Gastroparesis
Quality of Life
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-04-05
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Score in a Quality of life assessment Questionnaire
timeFrame: During the clinicial visit at the day of enrollment(Day 1)
Secondary outcomes:
measure: Score in a Quality of life assessment Questionnaire
timeFrame: 1st follow-up, at 6 months from Date of enrollment
measure: Score in a Quality of life assessment Questionnaire
timeFrame: 2nd follow-up, at 12 months from date of enrollment
measure: Score in a Quality of life assessment Questionnaire
timeFrame: 3rd follow-up, at 18 months form date of enrollment
measure: Score in a Quality of life assessment Questionnaire
timeFrame: 4th(last) follow-up, At 24 months form date of enrollment
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Shahnaz Sultan, MD
role: PRINCIPAL_INVESTIGATOR
References: