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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: Individual Physical Therapy (IPT)Experimental treatment 1 intervention
Group B: Group-based Physical Therapy (GPT)Experimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Pain - Numeric Rating Scale (NRS)

Pain will be assessed using the Numeric Rating Scale. Responses are scored to a total score on a 0-10 point scale with higher scores representing more pain.

Time frame
pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention
2

Pain Catastrophizing Scale (PCS)

Negative cognitive \& emotional responses to actual or anticipated pain will be assessed via the Pain Catastrophizing Scale. Responses are scored to a total score of 0-52 with a higher score reflecting more catastrophizing thoughts.

Time frame
pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention
3

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

Health-related quality of life (HRQL) will be assessed via the validated Knee Osteoarthritis Outcome Score (KOOS). Responses are summed on a 0-100-point scale, with lower score representing worse problems.

Time frame
pre-usual care, pre-intervention, immediate post-intervention, 6-months post-intervention,12-months post-intervention
4

Knee Osteoarthritis Outcome Score (KOOS) - Daily Living Function

Daily Living Function will be assessed via the validated Knee Osteoarthritis Outcome Score (KOOS). Responses are summed on a 0-100-point scale, with lower score representing worse problems.

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

Other outcomes

Sponsors and contacts

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University of Alberta

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator