NCT06447207

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
2mo left

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Aug 2024Jun 2026

First Submitted

Initial submission to the registry

May 21, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 13, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

May 21, 2024

Last Update Submit

May 19, 2025

Conditions

Keywords

LonelinessSocial Prescription

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, pre-intervention and immediately after the intervention

Secondary Outcomes (3)

  • Study Reach

    during the intervention

  • Social Participation and Social Activities

    baseline, pre-intervention and immediately after the intervention

  • Health-related Quality of Life with Social Satisfaction Focus

    baseline, pre-intervention and immediately after the intervention

Study Arms (1)

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

Behavioral: Occupational Therapy Led Social Prescription

Interventions

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.

Occupational Therapy Led Social Prescription

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Laura A Swink, PhD

    Colorado State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura A Swink, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: single group trial of occupational therapy led social prescription program for people with Parkinson disease
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2024

First Posted

June 7, 2024

Study Start

August 13, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations