Parkinson DiseaseNCT05084209
Preparing Patient-Caregiver Dyads with Parkinson's Disease for Future Decision Making
A study testing Parkinson's medical decision making support in people with Parkinson Disease, run by Purdue University at 1 site in United States.
Trial summary
Persons with Parkinson's disease and family care partners are often unprepared to make difficult, future medical decisions. Earlier conversations about future medical decisions between persons with Parkinson's disease and family care partners are needed before communication and cognitive difficulties become severe. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Parkinson's medical decision making support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2024to 27 Jan 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Cannot see well enough to see words on a newspaper even with corrective lenses
- Used the intervention resources before
- If cognition is questionable and cannot pass consent understanding questions
Trial locations and contacts
1 site in 1 country.
United States1 site
Purdue University
West Lafayette, Indiana, 47907-2069
About this study
Official title: Preparing Patient-Caregiver Dyads with Parkinson's Disease for End-of-Life Decision Making
Persons with Parkinson's disease and family care partners are often unprepared to make difficult, future medical decisions. Earlier conversations about future medical decisions between persons with Parkinson's disease and family care partners are needed before communication and cognitive difficulties become severe. In this study, the investigators will pilot test a novel dyadic intervention to help persons with Parkinson's disease and family care partners make future medical decisions. The investigators hypothesize the intervention will be feasible and acceptable among persons with Parkinson's disease and family care partners.
Read the detailed description
Investigators are looking for pairs of participants consisting of a person with a diagnosis of Parkinson's Disease, and a family care partner who is most likely to help make medical decisions in the future.
For this study, pairs will complete a survey to understand how engaged participants are in discussing future medical decisions, demographics, and the severity of Parkinson's disease. This survey will take about 15 minutes. Then, participants will work through a medical decision making support intervention together. Completing the intervention in-person, on the phone, or via video conferencing is acceptable. The resources will provide information on future medical decisions participants may need to make. The intervention is completely online and will take about 60 minutes to complete. Participants will have 2 weeks to complete the intervention.
The investigators will call participants a week after enrollment to ask about technical difficulties completing the intervention, provide assistance with intervention material navigation as needed, and answer questions about the intervention. Participants will receive another online survey 2 weeks after enrollment to understand engagement in discussing future medical decisions, and acceptability of the intervention. The 2 week survey will take about 15 minutes to complete.
- Conditions
- Parkinson Disease
- Being tested
- Parkinson's medical decision making support
- Keywords
- end of life, medical decision making, advanced illness, family
- Medical subject headings
- Parkinson Disease, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parkinson's medical decision making supportBehavioural
Participants will be asked to view and work through medical decision making support resources. The resources will include information on medical decisions that may occur in Parkinson's disease, and general medical decisions that anyone may need to make (i.e. choosing a medical decision maker). The resources will also include suggestions on how to discuss these decisions.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's medical decision making support intervention group | Experimental | All participants will complete an online medical decision making intervention, lasting about 60 minutes, and complete pre and post surveys. Receives: Behavioral: Parkinson's medical decision making support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Advance Care Planning Engagement Survey at 2 weeks
Assesses knowledge, contemplation, self-efficacy, and readiness on a 5-point Likert scale.
Measured: Baseline, 2 weeks post intervention
Intervention feasibility/acceptability
Ratings of ease of use, helpfulness, and likeliness of recommending the intervention to others on Likert-scales.
Measured: 2 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start26 Jun 2024
- Primary completion27 Aug 2024
- Study completion27 Jan 2025
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayun Xu, Purdue University
- Investigators
- Jiayun Xu, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084209
- Sponsor's protocol ID
- K23NR019099-01A1
- Status last verified
- Feb 2025
- First submitted
- 25 Sep 2021
- Last updated
- 10 Feb 2025
- 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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing Patient-Caregiver Dyads with Parkinson's Disease for End-of-Life Decision Making
- ClinicalTrials.gov ID
- NCT05084209
- Acronym / sponsor ID
- K23NR019099-01A1
- Conditions
- Parkinson Disease
- Keywords
- end of life, medical decision making, advanced illness, family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 19 Oct 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.
Persons with Parkinson's disease and family care partners are often unprepared to make difficult, future medical decisions. Earlier conversations about future medical decisions between persons with Parkinson's disease and family care partners are needed before communication and cognitive difficulties become severe. In this study, the investigators will pilot test a novel dyadic intervention to help persons with Parkinson's disease and family care partners make future medical decisions. The investigators hypothesize the intervention will be feasible and acceptable among persons with Parkinson's disease and family care partners.
Detailed description
Investigators are looking for pairs of participants consisting of a person with a diagnosis of Parkinson's Disease, and a family care partner who is most likely to help make medical decisions in the future.
For this study, pairs will complete a survey to understand how engaged participants are in discussing future medical decisions, demographics, and the severity of Parkinson's disease. This survey will take about 15 minutes. Then, participants will work through a medical decision making support intervention together. Completing the intervention in-person, on the phone, or via video conferencing is acceptable. The resources will provide information on future medical decisions participants may need to make. The intervention is completely online and will take about 60 minutes to complete. Participants will have 2 weeks to complete the intervention.
The investigators will call participants a week after enrollment to ask about technical difficulties completing the intervention, provide assistance with intervention material navigation as needed, and answer questions about the intervention. Participants will receive another online survey 2 weeks after enrollment to understand engagement in discussing future medical decisions, and acceptability of the intervention. The 2 week survey will take about 15 minutes to complete.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's medical decision making support intervention group | Experimental | Behavioral: Parkinson's medical decision making supportAll participants will complete an online medical decision making intervention, lasting about 60 minutes, and complete pre and post surveys. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Cannot see well enough to see words on a newspaper even with corrective lenses
- Used the intervention resources before
- If cognition is questionable and cannot pass consent understanding questions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parkinson's medical decision making supportParticipants will be asked to view and work through medical decision making support resources. The resources will include information on medical decisions that may occur in Parkinson's disease, and general medical decisions that anyone may need to make (i.e. choosing a medical decision maker). The resources will also include suggestions on how to discuss these decisions. | Behavioural | Parkinson's medical decision making support intervention group |
Primary outcome
Change from baseline Advance Care Planning Engagement Survey at 2 weeks
Time frame: Baseline, 2 weeks post intervention
Assesses knowledge, contemplation, self-efficacy, and readiness on a 5-point Likert scale.
Intervention feasibility/acceptability
Time frame: 2 weeks post intervention
Ratings of ease of use, helpfulness, and likeliness of recommending the intervention to others on Likert-scales.
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 10 Feb 2025.
- 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.
Jiayun Xu principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parkinson's medical decision making support in people with Parkinson Disease, run by Purdue 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 0 inclusion and 3 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 10 Feb 2025. 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?
Change from baseline Advance Care Planning Engagement Survey at 2 weeks (time frame: Baseline, 2 weeks post intervention). The study lists 2 primary outcomes in all. 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 10 Feb 2025.