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

Tranzyme, Inc.40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetes Mellitus Gastroparesis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject has Type 1 or Type 2 diabetes mellitus 2. Subject is 18 to 70 years old 3. Subject has chronic, active symptoms of gastroparesis for at least the past three months 4. Subject has confirmed delayed gastric emptying by scintigraphy, a breath test, or the SmartPill® wireless motility capsule 5. Subject can speak and read English 6. Subject is able to give his/her informed consent Exclusion Criteria: 1\. Subject has a cognitive, psychological or other (e.g., visual) impairment that would interfere with completing the study visit \-

Locations (4)

University of Kansas Medical Center

Kansas City, Kansas, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Temple University Health Sciences Center

Philadelphia, Pennsylvania, United States

Texas Tech University Health Sciences Center

El Paso, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 90-minute interview

Data from ClinicalTrials.gov

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