Adapting REhabilitation Delivery for Maximum Impact at Home

NCT05164575 | Completed

• 1 other identifier: Pro00110340
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Hip and knee osteoarthritis (OA) is a burden of disability in adults, with many seeking total joint arthroplasty (TJA) to reduce their symptoms. Almost 50% of people screened for TJA are referred for further rehabilitation rather than TJA. However, access to community-based rehabilitation is limited for those living in rural settings. Recent advances in tele-rehabilitation using smart phone technology, widely available in rural areas, provides a means to access rehabilitation from home. ReDI@Home will examine the impact of home-based e-Rehabilitation, delivered via smart phone, for rural residents living with moderate to advanced OA. This randomized feasibility trial will compare 2 e-Rehabilitation programs (eRP) of varying intensity (eRP-LOw Intensity \[eRP-LO\] and eRP-HIgh Intensity \[eRP- HI\]). The investigators think that the eRP are feasible and that both eRP will improve OA self-management. However, eRP-HI will improve patient outcomes more than eRP-LO.

Conditions

Osteo Arthritis Knee; Hip Osteoarthritis; Knee Osteoarthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• Change in Patient Activation Measure from baseline to post intervention and 6-months and 12-months

  Self-management A13-item survey that assesses a person's underlying knowledge, skills and confidence integral to managing his or her own health and healthcare. PAM segments individuals into one of four activation levels along an empirically derived 100-point scale. Each level provides insight into an extensive array of health-related characteristics, including attitudes, motivators, and behaviors. Individuals with a low score do not yet understand the importance of their role in managing their own health, and have significant knowledge gaps and limited self-management skills. Individuals with higher scores are proactive with their health, have developed strong self management skills, and are resilient in times of stress or change.

  At 0- weeks (pre-intervention), 9-weeks (post-intervention) and 6- and 12-months following randomization.

Secondary Outcomes (10)

• Change in Hip Disability and Osteoarthritis Outcome Score from baseline to post intervention and 6-months and 12-months

  At 0- weeks (pre-intervention), 9-weeks (post-intervention) and 6- and 12-months following randomization.

• Change in Knee Osteoarthritis Outcome Score from baseline to post intervention and 6-months and 12-months

  At 0- weeks (pre-intervention), 9-weeks (post-intervention) and 6- and 12-months following randomization.

• Change in Intermittent and Constant Osteoarthritis Pain from baseline to post intervention and 6-months and 12-months

  At 0- weeks (pre-intervention), 9-weeks (post-intervention) and 6- and 12-months following randomization.

• Change in Hospital Anxiety and Depression Scale from baseline to post intervention and 6-months and 12-months

  At 0- weeks (pre-intervention), 9-weeks (post-intervention) and 6- and 12-months following randomization.

• Change in Pain Catastrophizing Scale from baseline to post intervention and 6-months and 12-months

  At 0- weeks (pre-intervention), 9-weeks (post-intervention) and 6- and 12-months following randomization.

Study Arms (2)

eRP-LOw Intensity (eRP-LO)

EXPERIMENTAL

an 8-week intervention that includes FOUR virtual visits with a physiotherapist

Behavioral: progressive resistance exercise; Behavioral: self-management strategies

eRP-HIgh Intensity (eRP-HI)

EXPERIMENTAL

an 8-week intervention that includes EIGHT virtual visits with a physiotherapist

Behavioral: progressive resistance exercise; Behavioral: self-management strategies

Interventions

progressive resistance exercise BEHAVIORAL

Progressive resistance exercise program and self-management strategies. Participants will be provided with Theraband to progress exercise intensity, a FitBit to monitor physical activity, an audio-journal to promote self-reflection, and educational materials provided as part of usual OA care.

eRP-HIgh Intensity (eRP-HI); eRP-LOw Intensity (eRP-LO)

self-management strategies BEHAVIORAL

Progressive resistance exercise program and self-management strategies. Participants will be provided with Theraband to progress exercise intensity, a FitBit to monitor physical activity, an audio-journal to promote self-reflection, and educational materials provided as part of usual OA care.

eRP-HIgh Intensity (eRP-HI); eRP-LOw Intensity (eRP-LO)

Eligibility Criteria

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

You may qualify if:

• Present to the Edmonton or Camrose screening clinic with moderate to advanced hip or knee OA not eligible for TJA within one year (i.e., not RA, not currently waiting for TJA)
• Reside outside of metro Edmonton (defined by StatsCan)
• Access to a smart phone or tablet with embedded camera that can accept intervention software, with a current data plan in place and/or strong WiFi or ethernet connection\*
• English-speaking
• Are in need of guided exercise but are a functional community ambulator (with or without aids)
• Experience hip or knee pain multiple days a week
• Have activity limitations because of joint pain

You may not qualify if:

• Patients who are not eligible for TJA due to uncontrolled medical conditions (e.g., diabetes, hypertension) will be excluded due to safety concerns (i.e., undertaking exercise in their health state).

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Edmonton Bone and Joint Centre

Edmonton, Alberta, T5E5R8, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: ReDI@Home will be a randomized, parallel-arm, single-blind (clinical assessor) feasibility trial with participants randomized to eRP-HI or eRP-LO. An uneven block randomization sequence will be computer-generated with a 1:1 group allocation. Randomization will occur after the pre-intervention visit. The research coordinator will randomize participants after the equipment/software set-up and the pre-intervention assessment has been completed. The assigned intervention PT will contact participants to review the eRP and set up appointments as required based on group assignment. We will use one PT for all eRP-LO participants and up to 2 PTs to provide the eRP-HI intervention. Participants will have the same PT throughout, with visits scheduled during the day or early evening at PT and participant preference/availability, as per our previous COACH study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: eRP-LOw Intensity (eRP-LO) will be an 8-week intervention that includes FOUR virtual visits with a physiotherapist (PT) while eRP-HIgh Intensity (eRP-HI) will be an 8-week intervention with EIGHT virtual weekly visits with a PT. Both interventions will include a progressive resistance exercise program and self-management strategies. Participants will be provided with Theraband to progress exercise intensity, a FitBit to monitor physical activity, an audio-journal to promote self-reflection, and educational materials provided as part of usual OA care.

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: December 20, 2021
• Study Start: December 9, 2021
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: August 30, 2024

Record last verified: 2024-08

Locations

CA (1)