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CompletedNCT05084209Updated Feb 10, 2025

Preparing Patient-Caregiver Dyads with Parkinson's Disease for Future Decision Making

An interventional study of Parkinson's medical decision making support in Parkinson Disease, sponsored by Purdue University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-10.

Sponsored by Purdue University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Parkinson Disease

Keywords

  • end of life
  • medical decision making
  • advanced illness
  • family
03

In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 33 is below the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Purdue University is the lead sponsor of 174 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Person with Parkinson's Disease Inclusion Criteria:

  • Self-report a clinical diagnosis of Parkinson Disease
  • Does not have a diagnosis of dementia
  • Speak and read English
  • Have access to a reliable phone or internet connection
  • Have access to an online connection through a smartphone, tablet, or computer device
  • Be comfortable navigating websites or have someone available to assist
  • Agree to be audio recorded during intervention

Care Partner Inclusion Criteria:

  • Self-identify as the family member who will likely make medical decisions for the person with Parkinson Disease in the future OR who is the legally appointed health care representative
  • Self-report not having a diagnosis of dementia
  • Speak and read English
  • Have access to a reliable phone or internet connection
  • Have access to an online connection through a smartphone, tablet, or computer device
  • Be comfortable navigating websites or have someone available to assist
  • Agree to be audio recorded during intervention

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Parkinson's medical decision making support intervention group

    All participants will complete an online medical decision making intervention, lasting about 60 minutes, and complete pre and post surveys.

    Behavioral: Parkinson's medical decision making support

Interventions

  • BehavioralParkinson's medical decision making support

    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.

06

What researchers measure

Primary outcomes

  1. Change from baseline Advance Care Planning Engagement Survey at 2 weeks

    Assesses knowledge, contemplation, self-efficacy, and readiness on a 5-point Likert scale.

    Time frame: Baseline, 2 weeks post intervention

  2. Intervention feasibility/acceptability

    Ratings of ease of use, helpfulness, and likeliness of recommending the intervention to others on Likert-scales.

    Time frame: 2 weeks post intervention

07

Study locations

1 site
  • Purdue University
    West Lafayette, Indiana 47907-2069, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2024 to primary completion in Aug 2024, 2 months.

Of 1,296 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 2 months is below that.

Counting every sponsor, half of 1,369 studies reached it within 24 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2021
First posted
Oct 19, 2021
StartActual
Jun 26, 2024
Primary completionActual
Aug 27, 2024
CompletionActual
Jan 27, 2025
Last update
Feb 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05084209
Lead sponsor
Purdue University
Responsible party
Jiayun Xu (Assistant Professor, Purdue University) — Principal investigator
First posted
Oct 19, 2021
Start date
Jun 26, 2024
Primary completion
Aug 27, 2024
Completion
Jan 27, 2025
Last update
Feb 10, 2025

Study contacts

Jiayun Xu
principal investigator · Purdue University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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