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

Parkinson Disease Clinical Trial

Official title:

Preparing Patient-Caregiver Dyads With Parkinson's Disease for End-of-Life Decision Making

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05084209
• Other study ID #: K23NR019099-01A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2023
• Source: Purdue University
• Contact: Jiayun Xu
• Phone: 765-494-4017
• Email: xu1115[@]purdue.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 half an hour. 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 30 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Exclusion Criteria:

• Cannot see well enough to see words on a newspaper even with corrective lenses

• Used the intervention resources before

• Scored below a 28 on the telephone interview for cognitive status tool

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Purdue University	West Lafayette	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Purdue University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Advance Care Planning Engagement Survey at 2 weeks	Assesses knowledge, contemplation, self-efficacy, and readiness on a 5-point Likert scale.	Baseline, 2 weeks post intervention
Primary	Intervention feasibility/acceptability	Ratings of ease of use, helpfulness, and likeliness of recommending the intervention to others on Likert-scales.	2 weeks post intervention