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

February 6, 2025 updated by: Jiayun Xu, Purdue University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

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
    • Indiana
      • West Lafayette, Indiana, United States, 47907-2069
        • Purdue 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 2 weeks post intervention
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.
2 weeks post intervention

Collaborators and Investigators

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

Sponsor

Purdue University

Investigators

  • Principal Investigator: Jiayun Xu, Purdue 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)

June 26, 2024

Primary Completion (Actual)

August 27, 2024

Study Completion (Actual)

January 27, 2025

Study Registration Dates

First Submitted

September 25, 2021

First Submitted That Met QC Criteria

October 6, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23NR019099-01A1 (U.S. NIH Grant/Contract)

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

product manufactured in and exported from the U.S.

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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