Parkinson DiseaseNCT04769843
Impact of Swallowing Impairment on Individuals With Parkinson Disease
An observational study of Parkinson Disease and Dysphagia, run by Northern Arizona University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson Disease, Dysphagia
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participants must currently have oropharyngeal dysphagia and Parkinson Disease
- Participants must be at least 18 years of age
- Participants must speak English.
Who cannot join
- Participants whose receptive and expressive language skills will not allow them to participate in one-on-one interviews
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern Arizona University
Flagstaff, Arizona, 86005
About this study
Official title: 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!
Read the 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.
- Conditions
- Parkinson Disease, Dysphagia
- Medical subject headings
- Parkinson Disease, Deglutition Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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).
Measured: The Brief IPQ will be mailed to participants after their interview and asked to complete it and return it to us within one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start24 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Bartlett, Northern Arizona University
- Investigators
- Rebecca S Bartlett, PhD, Principal investigator, Northern Arizona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769843
- Sponsor's protocol ID
- 1508794
- Status last verified
- Jan 2022
- First submitted
- 19 Feb 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating the Psychological Consequences of Dysphagia Into Swallowing Care: A Preliminary Investigation
- ClinicalTrials.gov ID
- NCT04769843
- Acronym / sponsor ID
- 1508794
- Conditions
- Parkinson Disease, Dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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!
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Participants must currently have oropharyngeal dysphagia and Parkinson Disease
- Participants must be at least 18 years of age
- Participants must speak English.
Key exclusion criteria (1 listed)
- Participants whose receptive and expressive language skills will not allow them to participate in one-on-one interviews
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca S Bartlett, PhD principal investigator
Northern Arizona University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Dysphagia, run by Northern Arizona University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.