Applying the Pathways and Resources for Engagement and Participation Protocol Among People With Muscles Dystrophies

NCT06540365 | Not Yet Recruiting

• 1 other identifier: DBMD PREP Intervention
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

Taking part in community activities is essential for health and well-being. Yet, it is highly restricted for young people with Duchenne and Becker Muscular Dystrophies (DBMD), especially as they grow into adulthood. The Participation Pathways and Resources for Engagement and Participation (PREP) intervention is designed to help remove barriers in the environment. This study aims to see if the PREP intervention is useful and practical for youth and young adults with DBMD. The main question is: How useful is the PREP intervention for improving participation in community-based activities chosen by the participants? Participants will start the study at different times (4, 5, or 6 weeks) and work one-on-one with an occupational therapist on a leisure activity of their choice. They will have eight sessions over 12 to 18 weeks to work on this activity. They will use the Canadian Occupational Performance Measure (COPM) every week to track their performance and satisfaction with the chosen activity before, during, and after the intervention. The findings of this study can guide clinicians, families, and policymakers to select effective approaches that promote the participation of youth and young adults with DBMD in 'real world' activities they choose. It can also increase motivation and compliance and reduce the burden on the healthcare system, families, and people with DBMD themselves.

Conditions

Duchenne Muscular Dystrophy; Becker Muscular Dystrophy

Outcome Measures

Primary Outcomes (1)

• Canadian Occupational Performance Measure

  A gold-standard 10-point scale that measures activity performance and satisfaction. The score ranges from 1 (unable to perform) to 10 (performs extremely well)

  Up to 18 weeks (once a week, during base-line and intervention phase)

Study Arms (1)

Community-Based activity program

EXPERIMENTAL

Behavioral: Pathways and Resources for Engagement and Participation (PREP)

Interventions

Pathways and Resources for Engagement and Participation (PREP) BEHAVIORAL

Each participant will work individually with an occupational therapist (OT) to pursue one leisure-oriented, community-based activity chosen by the young person. The participant will choose the community program using the PREP 5 steps (Make goals; Map out a plan; Make it happen; Measure the process and outcomes; Move forward). The OT will then search for the appropriate program, identify and remove potential environmental barriers to participation in that activity (e.g., accessibility, equipment), and educate program instructors regarding the person's specific needs. This process will include an expected 8 sessions lasting 12 to 18 weeks (depending on the assigned baseline length).

Community-Based activity program

Eligibility Criteria

• Age: 14 Years - 30 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• diagnosed with DBMD
• aged 14-30 years
• from any sector of Israeli society.

You may not qualify if:

• have previously received the PREP intervention

Sponsors & Collaborators

• University of Haifa: lead
• McGill University: collaborator

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Michal Waisman-Nitzan, Dr

  University of Haifa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Waisman-Nitzan, Dr

CONTACT

972-544552728; michalwni@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty member

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 6, 2024
• Study Start: August 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08