Adapting Rehabilitation Delivery for Maximum Impact at Home-2 (ReDI-2)

NCT07055113 | Recruiting

• 1 other identifier: Pro00153489
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

People who live in rural areas and have hip or knee arthritis can have difficulty receiving physical therapy (PT) close to home. Living with hip or knee arthritis can make doing daily activities and being physically active difficult. This can lead to other health conditions, such as becoming overweight, or lessen enjoyment of life. We will compare 2 programs that allow physical therapists to treat rural residents in their own home to each other and to usual care. Usual care is the care that is typically provided to people living with hip or knee arthritis. For the first 12 weeks, participants will continue usual osteoarthritis (OA) care and then complete the standardized questionnaires again. Then, they will be randomized to either Individual (IPT) or Group-based PT (GPT). Over 12-weeks, therapists will meet virtually with patients using Zoom so that patients and therapists can see each other. The program will be either a class or one-on-one with a therapist. In the class, participants will still receive private one-to-one time with the therapist using a Zoom 'breakout' room. Therapists in both groups will help patients do exercises correctly in their home. Patients can also see and talk to the therapists to discuss their challenges in living with OA and set personalized goals including pain management, participating in valued daily activities, keeping healthy (diet, sleep) and being active. Both programs will allow patients who sometimes cannot access physical therapy to receive care in their home.

Conditions

Knee Osteoarthritis; Hip Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Patient Activation Measure (PAM)

  Self-management will be measured using the validated 13-item Patient Activation Measure (PAM). Responses are scored to a total score on a 0-100-point scale with higher scores representing higher patient activation.

  pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention

Secondary Outcomes (17)

• Pain - Numeric Rating Scale (NRS)

  pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention

• Pain Catastrophizing Scale (PCS)

  pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention

• Knee Osteoarthritis Outcome Score (KOOS) - Health-Related Quality of life (HRQL)

  pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention

• Knee Osteoarthritis Outcome Score (KOOS) - Daily Living Function

  pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention

• Hip Osteoarthritis Outcome Score (HOOS) - Health-Related Quality of life (HRQL)

  pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention

Study Arms (2)

Individual Physical Therapy (IPT)

EXPERIMENTAL

12-week virtual physical therapy that includes one-on-one visits with a physiotherapist.

Behavioral: Individual-based Virtual Physical Therapy Program

Group-based Physical Therapy (GPT)

EXPERIMENTAL

12-week virtual physical therapy that includes group classes (4-5 participants) with two physiotherapists. In each session, each participant will also have a 10-12 min one-on-one interaction with one of the physiotherapists.

Behavioral: Group-based Virtual Physical Therapy Program

Interventions

Individual-based Virtual Physical Therapy Program BEHAVIORAL

Twelve-week virtual physical therapy that includes one-on-one visits with a physiotherapist. Multi-modal Self-management program comprises: * Education to understand OA and its management: 'Understanding \& Managing OA'; 'Activity \& Exercise'; 'Managing Pain'; 'Healthy Eating'; 'Mental \& Emotional Well-being'; 'General Wellness'. * Personalized Goal Setting in partnership with therapist to promote patient activation. * Progressive neuro-muscular exercises of the core and lower extremity, customized to patient capacity with participants encouraged to perform exercises at least 2 times/week between PT sessions to improve strength and function; 2 levels of resistance bands will be provided to progress resistance. * Physical activity goals using FitBit step count, to increase daily activity as tolerated.

Individual Physical Therapy (IPT)

Group-based Virtual Physical Therapy Program BEHAVIORAL

Twelve-week virtual physical therapy that includes group classes (4-5 participants) with two physiotherapists. In each session, each participant will also have a 10-12 min one-on-one interaction with one of the physiotherapists. Multi-modal Self-management program comprises: Education to understand OA and its management: 'Understanding \& Managing OA'; 'Activity \& Exercise'; 'Managing Pain'; 'Healthy Eating'; 'Mental \& Emotional Well-being'; 'General Wellness'. Personalized Goal Setting in partnership with therapist to promote patient activation. Progressive neuro-muscular exercises of the core and lower extremity, customized to patient capacity with participants encouraged to perform exercises at least 2 times/week between PT sessions to improve strength and function; 2 levels of resistance bands will be provided to progress resistance. Physical activity goals using FitBit step count, to increase daily activity as tolerated.

Group-based Physical Therapy (GPT)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with confirmed hip or knee OA, but deemed to not require total joint arthroplasty (i.e., not on the surgical waitlist)
• Not currently be attending physiotherapy
• Reside outside of Edmonton or nearby communities
• English-speaking
• with access to a Zoom-friendly device (smart phone, tablet, laptop).

Sponsors & Collaborators

• University of Alberta: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Edmonton Bone and Joint Centre

Edmonton, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Lauren Beaupre, PT, PhD

CONTACT

780-492-8626; lauren.beaupre@ualberta.ca

Ailar Ramadi, PT, PhD

CONTACT

780-492-2398; Ailar.Ramadi@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After providing consent, all participants will be assessed using standardized measures and then continue 12-weeks of community-based OA usual care. Following 12-weeks of usual care, they will be randomized to either of the intervention arms.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 8, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)