Clinical trial NCT06447207: Occupational Therapy Led Social Prescription for People With Parkinson Disease
Official title: Social Prescription for Loneliness in Community-based Group Exercise Classes for People With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Loneliness
Social Prescription
Lead sponsor: Colorado State University
Sponsor class: OTHER
Collaborators: name: American Occupational Therapy Foundation
First posted: 2024-06-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group trial of occupational therapy led social prescription program for people with Parkinson disease
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The Three-Item Loneliness Scale
timeFrame: baseline, pre-intervention and immediately after the intervention
Secondary outcomes:
measure: Study Reach
timeFrame: during the intervention
measure: Social Participation and Social Activities
timeFrame: baseline, pre-intervention and immediately after the intervention
measure: Health-related Quality of Life with Social Satisfaction Focus
timeFrame: baseline, pre-intervention and immediately after the intervention
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
affiliation: Colorado State University
name: Laura A Swink, PhD
role: PRINCIPAL_INVESTIGATOR
References: