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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01316484

Enrollment

Registered

2011-03-16

Start date

2011-03-31

Completion date

2011-04-30

Last updated

2011-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Gastroparesis

Keywords

Cognitive Debriefing

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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 \-

Design outcomes

Primary

Measure	Time frame	Description
Qualitative, Content Analysis of Cognitive Debriefing Data	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.

Countries

United States

Outcome results