Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447207
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-21
Brief Title:
Occupational Therapy Led Social Prescription for People With Parkinson Disease
Sponsor:
Colorado State University
Organization:
Colorado State University
Study Overview
Official Title:
Social Prescription for Loneliness in Community-based Group Exercise Classes for People With Parkinson Disease
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Loneliness is an epidemic that the US Surgeon General implored must be addressed by society as a whole Increased loneliness ie distressing feelings of isolation in people with Parkinsons 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 Colorados Parkinsons 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
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:
Parkinsons 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 ie 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 eg 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 59 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 eg PAR staff evaluation with a coordinator eg OT and partnerships with local organizations eg PAR The investigators developed a preliminary resource manual to identify resources within each of the 11 interventions recommended within social prescription eg 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 samplesite selection of strategies to address change Now in steps 45 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 Parkinsons disease using a single-site pilot trial
Aim 2 Evaluate the OT-led social prescription for people with Parkinsons 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
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 eg PAR staff evaluation with a coordinator eg OT and partnerships with local organizations eg PAR The investigators developed a preliminary resource manual to identify resources within each of the 11 interventions recommended within social prescription eg 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 samplesite selection of strategies to address change Now in steps 45 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 Parkinsons disease using a single-site pilot trial
Aim 2 Evaluate the OT-led social prescription for people with Parkinsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None