Impact of Swallowing Impairment on Individuals With Parkinson Disease

January 26, 2022 updated by: Rebecca Bartlett, Northern Arizona University

Incorporating the Psychological Consequences of Dysphagia Into Swallowing Care: A Preliminary Investigation

In this online study, investigators will explore the psychosocial burdens of swallowing difficulties in people with Parkinson's Disease. This study is completely virtual, so you can participate from wherever you live in the United States. Participation requires you to complete a one-hour Zoom interview and a brief questionnaire. You will be compensated with a $25 Walmart gift card. To learn more, please use the "send email" feature. Thank you!

Study Overview

Status

Completed

Conditions

Detailed Description

This is a mixed methods study. The investigators will collect qualitative data from participants by conducting 1-2 hour semi-structured interviews on Zoom. The interview questions are designed to systemically inquire about patient experiences, affective reactions, coping strategies, social support, self-identity issues, and treatment experiences. The investigators will collect quantitative data by asking participants to complete The Brief Illness Perception Questionnaire. The data will be analyzed using a comprehensive stress and coping model, which has not been done previously in the field. The investigators hope to discover themes about psychosocial burdens and related coping mechanisms.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Flagstaff, Arizona, United States, 86005
        • Northern Arizona University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from 1) local Parkinson Disease support groups, 2) through referrals from local speech-language pathologists, and 3) through the Fox Trial Finder on the Michael J. Fox Foundation website.

Description

Inclusion Criteria:

  • Participants must currently have oropharyngeal dysphagia and Parkinson Disease
  • Participants must be at least 18 years of age
  • Participants must speak English.

Exclusion Criteria:

  • Participants whose receptive and expressive language skills will not allow them to participate in one-on-one interviews

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of the Impact of Swallowing Impairment on Individuals with Parkinson Disease as Expressed During Interviews
Time Frame: To be assessed from the participant interviews through study completion, an average of 1 year.
A 1-2 hour, semi-structured interview will be conducted with each participant on Zoom to identify patient experiences, affective reactions, coping strategies, social support, self-identity issues, and treatment experiences associated with swallowing impairment.
To be assessed from the participant interviews through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Score on Brief Illness Perception Questionnaire (Brief IPQ) as Self-Reported by Participants
Time Frame: The Brief IPQ will be mailed to participants after their interview and asked to complete it and return it to us within one week.
The Brief IPQ is a self-report survey that contains nine items that quantify the cognitive and emotional representations of an illness. It has good test-retest reliability and concurrent validity with relevant measures in a few populations with chronic disease. Scores range from 0 (i.e., illness has no effect on life) to 80 points (i.e., illness extremely effects various aspects of life).
The Brief IPQ will be mailed to participants after their interview and asked to complete it and return it to us within one week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Arizona University

Investigators

  • Principal Investigator: Rebecca S Bartlett, PhD, Northern Arizona University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 19, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1508794

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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