Patient Understanding (Cognitive Debriefing) of a Daily Diary of Gastroparesis Symptoms

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.

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Key information

Conditions

Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Gastroparesis Glucose Metabolism Disorders Metabolic Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center, Kansas City, Kansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Subject has a cognitive, psychological or other (e.g., visual) impairment that would interfere with completing the study visit

Treatment and study plan

Primary outcomes

Qualitative, Content Analysis of Cognitive Debriefing Data

Time frame: 90-minute interview

The cognitive debriefing data will be content analyzed for patient understanding of the concepts in the questionnaire and interpretation of the items' content.

Sponsors and collaborators

Lead sponsor

Tranzyme, Inc.

Industry

Registry information

Official study title

Protocol for the Patient Understanding (Cognitive Debriefing) of a Modified Gastroparesis Cardinal Symptom Index (GCSI) Daily Diary

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Mar 16, 2011
Registry last updated: May 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed