Occupational Therapy Intervention for Parkinson's (NCT07094269)
Increase energy conservation self efficacy
- Trial ID
- NCT07094269
- Official Title
- Protocol for a Superiority Randomized Controlled Trial of a Group-Based Fatigue Management Program Versus Standard Information to Improve Self-Efficacy in Energy Conservation in Parkinson's Disease
- Goal
- Increase energy conservation self efficacy
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Universita degli Studi di Genova
- Study Type
- INTERVENTIONAL
- Enrollment
- 80 participants
- Conditions
- PARKINSON DISEASE (Disorder)
- Interventions
- Occupational Therapy Intervention, Fact-sheets
Summary For Families
The goal is to help people with Parkinson's who have significant, persistent fatigue learn to save energy and feel more confident managing daily activities. The approach is a group-based occupational therapy program that teaches practical energy conservation skills, such as activity pacing, task prioritizing, planning rest breaks, using simpler methods or aids, and rehearsing routines, compared with receiving standard fact-sheets; this is a behavioral, non-drug intervention so it does not change medications like levodopa. The trial is looking for adults 18 and older with idiopathic Parkinson's, Hoehn and Yahr stage 3.5 or lower, a Fatigue Severity Scale score of 4 or more, and a MoCA score of at least 22, excluding people with other medical causes of fatigue or non-Italian speakers.
Locations
- Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal Child Health (DINOGMI) University of Genoa Genoa, Italy, Genova, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Occupational Therapy Intervention. The goal is to help people with Parkinson's who have significant, persistent fatigue learn to save energy and feel more confident managing daily activities. The approach is a group-based occupational therapy program that teaches practical energy conservation skills, such as activity pacing, task prioritizing, planning rest breaks, using simpler methods or aids, and rehearsing routines, compared with receiving standard fact-sheets; this is a behavioral, non-drug intervention so it does not change medications like levodopa. The trial is looking for adults 18 and older with idiopathic Parkinson's, Hoehn and Yahr stage 3.5 or lower, a Fatigue Severity Scale score of 4 or more, and a MoCA score of at least 22, excluding people with other medical causes of fatigue or non-Italian speakers.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 11 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- The study lasts approximately 19 weeks, including a 6-week intervention and a 3-month follow-up.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Thinking & memory tests (non-invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.