Parkinson DiseaseNCT06447207
Occupational Therapy Led Social Prescription for People With Parkinson Disease
A study testing Occupational Therapy Led Social Prescription in people with Parkinson Disease, run by Colorado State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Occupational Therapy Led Social Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have ever been diagnosed with dementia
- Not fluent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80523
About this study
Official title: Social Prescription for Loneliness in Community-based Group Exercise Classes for People With Parkinson Disease
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.
Read the 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
- Being tested
- Occupational Therapy Led Social Prescription
- Keywords
- Loneliness, Social Prescription
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Therapy Led Social PrescriptionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Occupational Therapy Led Social Prescription | Experimental | (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 Receives: Behavioral: Occupational Therapy Led Social Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Three-Item Loneliness Scale
The Three-Item Loneliness Scale is an assessment of loneliness scored 3-9 with higher scores indicating greater (worse) loneliness.
Measured: baseline, pre-intervention and immediately after the intervention
Secondary outcomes (3)
Study Reach
(1) % of participants screened for loneliness by PAR assessors in each class/total people in the class, (2) % eligible/total people screened, (3) % who enroll in OT-led social prescription/total people eligible, (4) # OT follow-up sessions completed (out of 6 total) on average for people who enrolled
Measured: during the intervention
Social Participation and Social Activities
Activity Card Sort Version 2 scores range from 0-100 with higher scores indicating greater retention of social roles and activities since diagnosis.
Measured: baseline, pre-intervention and immediately after the intervention
Health-related Quality of Life with Social Satisfaction Focus
The Satisfaction with Social Roles and Activities Short Form scores range from 8-40 with higher scores indicating greater satisfaction with social roles and activities.
Measured: baseline, pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start13 Aug 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group trial of occupational therapy led social prescription program for people with Parkinson disease
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Sponsor
- Investigators
- Laura A Swink, PhD, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447207
- Sponsor's protocol ID
- 5561
- Other IDs
- AOTFIR24Swink
- Status last verified
- Jun 2026
- First submitted
- 21 May 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Prescription for Loneliness in Community-based Group Exercise Classes for People With Parkinson Disease
- ClinicalTrials.gov ID
- NCT06447207
- Acronym / sponsor ID
- 5561
- Conditions
- Parkinson Disease
- Keywords
- Loneliness, Social Prescription
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group trial of occupational therapy led social prescription program for people with Parkinson disease
| Arm | Type | Receives |
|---|---|---|
| Occupational Therapy Led Social Prescription | Experimental | Behavioral: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Have ever been diagnosed with dementia
- Not fluent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational Therapy Led Social PrescriptionThe intervention includes encouragement to participate in the co-designed social prescription with 6 monthly sessions with an occupational therapist or occupational therapy doctoral student. | Behavioural | Occupational Therapy Led Social Prescription |
Primary outcome
The Three-Item Loneliness Scale
Time frame: baseline, pre-intervention and immediately after the intervention
The Three-Item Loneliness Scale is an assessment of loneliness scored 3-9 with higher scores indicating greater (worse) loneliness.
3 secondary outcomes
Study Reach
Time frame: during the intervention
Social Participation and Social Activities
Time frame: baseline, pre-intervention and immediately after the intervention
Health-related Quality of Life with Social Satisfaction Focus
Time frame: baseline, pre-intervention and immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura A Swink, PhD principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy Led Social Prescription in people with Parkinson Disease, run by Colorado State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Three-Item Loneliness Scale (time frame: baseline, pre-intervention and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.