Occupational Therapy Led Social Prescription for People With Parkinson Disease

NCT ID: NCT06447207

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-13
• Study Completion Date: 2026-06-30

Brief Summary

Loneliness is an epidemic that the U.S. Surgeon General implored must be addressed by society as a whole. Increased loneliness (i.e., distressing feelings of isolation) in people with Parkinson's disease (PD) has a pervasive impact and is associated with worsened motor and non-motor symptoms, and quality of life. The investigators expect that individuals participating socially in the community would experience less loneliness. However, for individuals with PD participating in community-based group exercise programs, the investigators have found that over one third still report being lonely. Therefore, an evidence-based program needs to be added to address a significant problem of loneliness for people with PD-and occupational therapy is the leading discipline to add the intervention because social participation is one of eight occupations that an occupational therapist is focused on optimizing. The chief executive officer at the Parkinson Association of the Rockies (PAR), members of the Colorado State University Occupational Therapy Department, and members of the University of Colorado's Parkinson's Exercise Research Consortium have teamed up to address pervasive loneliness.

Social prescription is a prime evidence-based intervention to add to existing PD community-based exercise classes because it has been shown to reduce loneliness. For this project, the investigators detect participants in the 'lonely' range through a standardized assessment. The investigators will work with PAR staff who will refer individuals identifying as 'lonely' to an occupational therapist, who will complete an individualized occupational profile and write the appropriate social prescription from 11 different interventions (examples include: intergenerational intervention, animal companions, physical activity, occupational therapy) from established community resources recommended for social prescription. The proposed project is designed with three primary goals: (1) determine the reach of the social prescription program, (2) evaluate the effectiveness of the program at one site, and (3) determine implementation strategies for scalability.

Detailed Description

Parkinson's disease (PD) is a neurodegenerative condition with no known cure. Current evidence-based practice focuses on slowing disease progression, reducing negative impacts of motor and non-motor symptoms, and improving quality of life. While approaches such as exercise, medications, and surgery are used to reduce impacts of PD symptoms, there is a gap in how to address loneliness, which is a significant factor associated with poor quality of life for people with PD. Loneliness is a vast problem in the United States, the Surgeon General released a 2023 report imploring a societal focus on addressing loneliness (i.e., distressing feelings of isolation)-and people with PD have an even higher prevalence of loneliness than the general population. Occupational therapists play a key role in addressing the loneliness epidemic for people with PD. Social participation is one of eight categories of occupation elucidated in the Occupational Therapy (OT) Practice Framework. Yet, limited OT guidelines exist on how to address the occupation of social participation. According to the 2022 OT Clinical Practice Guidelines for people with PD, moderate evidence exists for community-based group activity. Considering OT as a discipline focused on using occupation both as a means (training using social participation), and as an ends (reduction of loneliness), investigators should be on the forefront of evidence-based practice to address loneliness. Group format, community-based exercise is one approach with potential for addressing loneliness. Parkinson Association of the Rockies (PAR) offers 70+ weekly community-based group exercise classes in Colorado and surrounding states. For over two years, the investigators have been partnering with PAR to collect outcomes data of PAR exercise class participants in areas of psychosocial outcomes (e.g., loneliness), mobility, and quality of life. Interestingly, over one third of individuals with PD who are participating in the PAR group exercise classes self-report to be in the 'lonely' range (3-item UCLA Loneliness Scale [UTILS] score =5/9). After reviewing evidence-informed strategies to address loneliness, the investigators found a clear method already developed-social prescription. Social prescription offers a method to improve loneliness through further community connection in an individualized, meaningful way.

Evidence-based Practice to Address Loneliness

The process of social prescription is standardized, requiring identification into the program by a health professional or community member (e.g., PAR staff), evaluation with a coordinator (e.g., OT), and partnerships with local organizations (e.g., PAR). The investigators developed a preliminary resource manual to identify resources within each of the 11 interventions recommended within social prescription (e.g., intergenerational intervention, animal companions, physical activity, occupational therapy), and use an occupational profile to identify the individualized target area for each participant. The approach will follow the Grol & Wensing Implementation Process model in which the investigators have already completed Steps 1-3 (identifying the topic for change, analysis of sample/site, selection of strategies to address change). Now in steps 4&5 of the model, the investigators will implement social prescription with one organization, and then evaluate to adapt prior to scaling up to multiple organizations, with the following two aims:

Aim 1. Determine the reach of OT-led social prescription for people with Parkinson's disease using a single-site pilot trial.

Aim 2. Evaluate the OT-led social prescription for people with Parkinson's disease for a signal of effectiveness using a single-site pilot trial.

Aim 3. Determine implementation strategies to facilitate scalability of OT-led social prescription beyond the single-site and Colorado community.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Occupational Therapy Led Social Prescription

(1) A baseline occupational therapy assessment including a social prescription, (2) Six monthly occupational therapy follow-up sessions focused on behavior-change techniques to encourage participation in the social prescription, and include: review of the social prescription, self-monitoring strategies, facilitators review, barriers review, problem-solving, provision of feedback, action planning, and rating confidence with the action plan, and (3) Post Occupational Therapy Assessment

Group Type: EXPERIMENTAL

Occupational Therapy Led Social Prescription

Intervention Type: BEHAVIORAL

The intervention includes encouragement to participate in the co-designed social prescription with 6 monthly sessions with an occupational therapist or occupational therapy doctoral student.

Interventions

Occupational Therapy Led Social Prescription

The intervention includes encouragement to participate in the co-designed social prescription with 6 monthly sessions with an occupational therapist or occupational therapy doctoral student.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• At least 18 years old
• Have a diagnosis of Parkinson Disease
• Have participated in at least one exercise class or support group in the last year
• Scored ≥5/9 on the UCLA 3-item Loneliness Scale during pre-screening
• Agree to participate in a 6-month program including a social prescription and six visits with an occupational therapist or occupational therapy doctoral student

Exclusion Criteria

• Have ever been diagnosed with dementia
• Not fluent in English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Occupational Therapy Foundation

OTHER

Sponsor Role: collaborator

Colorado State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura A Swink, PhD

Role: PRINCIPAL_INVESTIGATOR

Colorado State University

Locations

Colorado State University

Fort Collins, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Laura A Swink, PhD

Role: CONTACT

laura.swink@colostate.edu

9704917915

Facility Contacts

Laura Swink, PhD

Role: primary

laura.swink@colostate.edu

970-491-7915

Other Identifiers

AOTFIR24Swink

Identifier Type: OTHER

Identifier Source: secondary_id

5561

Identifier Type: -

Identifier Source: org_study_id