Social Prescription for Parkinson's Disease

Overseen By Laura A Swink, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Colorado State University

Disqualifiers: Dementia, Not fluent in English

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on social prescriptions and occupational therapy to address loneliness in Parkinson's disease.

What data supports the effectiveness of the treatment Occupational Therapy Led Social Prescription for Parkinson's Disease?

Research suggests that occupational therapy can improve motor skills and quality of life for people with Parkinson's disease, although more high-quality studies are needed to confirm these benefits. ^{1 2 3 4 5}

Is occupational therapy safe for people with Parkinson's disease?

The research on occupational therapy for Parkinson's disease does not report any safety concerns, suggesting it is generally safe for humans. ^{1 2 3 4 6}

How is the Occupational Therapy Led Social Prescription treatment different from other treatments for Parkinson's disease?

The Occupational Therapy Led Social Prescription treatment is unique because it focuses on helping patients maintain their daily activities and adapt to changes in their physical and social environment, rather than relying solely on medication or surgery. This approach emphasizes improving quality of life and functional independence through personalized support and adaptation strategies. ^{1 2 3 5 7}

Research Team

Laura A Swink, PhD

Principal Investigator

Colorado State University

Eligibility Criteria

This trial is for adults over 18 with Parkinson's Disease who feel lonely, even if they've been socially active. They must have attended an exercise class or support group in the past year and scored high on a loneliness scale. Participants will engage in a 6-month program involving social activities prescribed by occupational therapists.

Inclusion Criteria

I have joined an exercise class or support group in the past year.

I am 18 years old or older.

I scored 5 or more on a loneliness test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

A baseline occupational therapy assessment including a social prescription

1 week

1 visit (in-person)

Intervention

Six monthly occupational therapy follow-up sessions focused on behavior-change techniques to encourage participation in the social prescription

6 months

6 visits (in-person)

Post-Intervention Assessment

Post Occupational Therapy Assessment to evaluate the effectiveness of the intervention

1 week

1 visit (in-person)

Follow-up

Participants are monitored for psychosocial outcomes, mobility, and quality of life after the intervention

4 weeks

Treatment Details

Interventions

• Occupational Therapy Led Social Prescription

Trial Overview The study tests whether 'social prescriptions' given by occupational therapists can reduce feelings of loneliness in people with Parkinson's Disease. It involves personalized activities from community resources to enhance social participation, alongside regular visits to the therapist.

Participant Groups

Group I: Occupational Therapy Led Social Prescription Experimental Treatment 1 Intervention

(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 Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

Findings from Research

Occupational therapy (OT) is an important complementary treatment for managing motor impairments and functional limitations in Parkinson's disease, as indicated by a review of eight studies.

While definitive conclusions are limited due to the absence of high-level studies, there is evidence that OT can lead to improvements in motor function and quality of life during the course of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enabling functional independence in Parkinson's disease: update on occupational therapy intervention. Rao, AK.[2010]

A proactive consultative occupational therapy program tailored for individuals with early Parkinson's disease (PD) was developed and evaluated, showing that 75% of participants reported high satisfaction with the program.

The program effectively addressed specific needs, such as hand strength and dexterity deficits, and demonstrated a high adherence rate (60%) to home exercise recommendations among participants who recalled the program, indicating its potential for improving quality of life in early PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational Therapy for People with Early Parkinson's Disease: A Retrospective Program Evaluation. Sadural, A., MacDonald, J., Johnson, J., et al.[2022]

Occupational therapy interventions focusing on meaningful activities significantly improve perceived occupational performance in people with Parkinson's disease, based on a review of 10 studies involving 1343 participants.

Upper limb therapy programs provided short-term improvements in upper limb function, suggesting that tailored, goal-oriented therapy plans are effective, although the long-term benefits remain uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of occupational therapy intervention for people with Parkinson's disease: Systematic review. Welsby, E., Berrigan, S., Laver, K.[2023]

A pilot trial involving 39 non-demented patients with Parkinson's disease showed that occupational therapy (OT) is feasible and acceptable, with low withdrawal rates and good completion of outcome questionnaires.

The study indicated that OT may improve functional independence and quality of life, as measured by the Nottingham Extended Activity of Daily Living Scale and the Parkinson's Disease Questionnaire, although the differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomised controlled trial of occupational therapy to optimise independence in Parkinson's disease: the PD OT trial. Clarke, CE., Furmston, A., Morgan, E., et al.[2021]

Occupational therapy showed some positive effects in patients with Parkinson's disease, but the improvements were small and based on only two trials involving 84 patients, highlighting the need for more robust research.

Due to significant methodological flaws and the small sample size of the studies, there is currently insufficient evidence to definitively support or refute the efficacy of occupational therapy for Parkinson's disease, indicating a need for larger, well-designed trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational therapy for patients with Parkinson's disease. Deane, KH., Ellis-Hill, C., Playford, ED., et al.[2018]

This study will evaluate the effectiveness of occupation-based interventions, both with and without responsibility feedback, compared to conventional therapies in improving participation among 45 individuals with Parkinson's disease over 12 weeks.

The trial aims to measure various outcomes related to participation and quality of life, potentially providing new insights into how structured occupational therapy can enhance both motor and non-motor symptoms in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of the effects of occupation-based interventions with and without responsibility feedback and conventional interventions on participation in people with idiopathic Parkinson's disease: study protocol for a randomized controlled trial. Meimandi, M., Azad, A., Ghani, JH., et al.[2023]

Occupational therapy (OT) is recognized as an important part of managing Parkinson's disease, but many patients in Israel do not seek this treatment, highlighting a gap in care.

To improve the utilization of OT, strategies such as providing specific training for therapists and increasing awareness among patients and referring physicians are essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational therapy for people with Parkinson's disease in Israel: A SWOT analysis. Cavaglion, A., Duvdevani, M., Siegelman, N., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Enabling functional independence in Parkinson's disease: update on occupational therapy intervention. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

Occupational Therapy for People with Early Parkinson's Disease: A Retrospective Program Evaluation. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Effectiveness of occupational therapy intervention for people with Parkinson's disease: Systematic review. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Pilot randomised controlled trial of occupational therapy to optimise independence in Parkinson's disease: the PD OT trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Occupational therapy for patients with Parkinson's disease. [2018]

6. England pubmed.ncbi.nlm.nih.gov

A comparison of the effects of occupation-based interventions with and without responsibility feedback and conventional interventions on participation in people with idiopathic Parkinson's disease: study protocol for a randomized controlled trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Occupational therapy for people with Parkinson's disease in Israel: A SWOT analysis. [2023]