Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06447207 |
| Other study ID # |
AOTFIR24Swink |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2024 |
| Est. completion date |
June 30, 2026 |
Study information
| Verified date |
June 2024 |
| Source |
Colorado State University |
| Contact |
Laura A Swink, PhD |
| Phone |
9704917915 |
| Email |
laura.swink[@]colostate.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
