Patient Understanding (Cognitive Debriefing) of a Daily Diary of Gastroparesis Symptoms
Protocol for the Patient Understanding (Cognitive Debriefing) of a Modified Gastroparesis Cardinal Symptom Index (GCSI) Daily Diary
1 other identifier
observational
40
1 country
4
Brief Summary
The primary objective of the study is to evaluate how patients with gastroparesis interpret the instructions, item content, and response options of a daily diary questionnaire designed to assess the key symptoms of gastroparesis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2011
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 14, 2011
CompletedFirst Posted
Study publicly available on registry
March 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 24, 2011
May 1, 2011
1 month
March 14, 2011
May 23, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Qualitative, Content Analysis of Cognitive Debriefing Data
The cognitive debriefing data will be content analyzed for patient understanding of the concepts in the questionnaire and interpretation of the items' content.
90-minute interview
Study Arms (1)
No Treatment
Adult subjects with diabetes mellitus and a diagnosis of gastroparesis
Eligibility Criteria
Hospital/Clinic Database
You may qualify if:
- Subject has Type 1 or Type 2 diabetes mellitus
- Subject is 18 to 70 years old
- Subject has chronic, active symptoms of gastroparesis for at least the past three months
- Subject has confirmed delayed gastric emptying by scintigraphy, a breath test, or the SmartPill® wireless motility capsule
- Subject can speak and read English
- Subject is able to give his/her informed consent
You may not qualify if:
- \. Subject has a cognitive, psychological or other (e.g., visual) impairment that would interfere with completing the study visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tranzyme, Inc.lead
Study Sites (4)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27517, United States
Temple University Health Sciences Center
Philadelphia, Pennsylvania, 19140, United States
Texas Tech University Health Sciences Center
El Paso, Texas, 79905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henry Parkman, MD
Temple University Health Sciences Center
- PRINCIPAL INVESTIGATOR
Tuba Esfandyari, MD
University of Kansas Medical Center
- PRINCIPAL INVESTIGATOR
Irene Sarosiek, MD
Texas Tech University Health Sciences Center
- PRINCIPAL INVESTIGATOR
Kenneth Koch, MD
Wake Forest University Health Sciences
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 14, 2011
First Posted
March 16, 2011
Study Start
March 1, 2011
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
May 24, 2011
Record last verified: 2011-05