NCT04769843

Brief Summary

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!

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

March 24, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

February 19, 2021

Last Update Submit

January 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Identification of the Impact of Swallowing Impairment on Individuals with Parkinson Disease as Expressed During Interviews

    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 Outcomes (1)

  • Overall Score on Brief Illness Perception Questionnaire (Brief IPQ) as Self-Reported by Participants

    The Brief IPQ will be mailed to participants after their interview and asked to complete it and return it to us within one week.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86005, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseDeglutition Disorders

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Rebecca S Bartlett, PhD

    Northern Arizona University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 25, 2021

Study Start

March 24, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 27, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations