Clinical trial NCT06963164: Testing of a New Joint Protection Program
Official title: Feasibility of a Remotely-Delivered, Technology-Enabled, Joint Protection Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hand Osteoarthritis
Keywords: hand osteoarthritis
randomize controlled trial
feasibility
pilot
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: The Arthritis Society, Canada
First posted: 2025-05-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to to examine the feasibility of a full-scale trial on Helping Hand, a new Joint Protection Program for Hand Osteoarthritis and to examine the acceptability of the new Joint Protection Program.

This study will not assess the effectiveness of the program, as it is not designed or powered to do so. Instead, the information gathered will be used to refine the trial design and ensure the future full-scale trial that will assess the effectiveness of the program is robust and successful. The acceptability of the new Joint Protection Program will be assessed through a survey that will be administered to the intervention group at the end of the trial, which will be based on a standardized acceptability framework

Participants will:

Gain access to an online Joint Protection Program or continue to receive usual care for 12 weeks Visit the clinic or complete online assessments once every 4 weeks Keep a diary of their symptoms and the number of times they used other interventions to manage their symptoms (i.e. painkillers)

Detailed description: The goal of this study is to to examine the feasibility of a definite trial on Helping Hand, a new Joint Protection Program for Hand Osteoarthritis and to examine the acceptability of the new Joint Protection Program.

Joint protection refers to a set of techniques and strategies that help reduce stress on the joints, manage pain, and prevent further joint damage. These techniques are particularly important for people with hand arthritis, as the small joints in the hands are often affected, leading to pain, stiffness, and difficulty performing daily tasks. Key principles of joint protection include:

1. Using larger, stronger joints whenever possible (e.g., using the forearm instead of the fingers to push open a door).
2. Reducing strain by spreading the load across multiple joints (e.g., carrying items with two hands instead of one).
3. Avoid tight gripping or pinching motions that can overstrain the joints.
4. Incorporating assistive devices to reduce effort during tasks (e.g., jar openers or ergonomic tools).
5. Pacing and prioritizing activities to avoid overuse of the joints and allow for adequate rest.

By adopting these strategies, people with hand arthritis can minimize discomfort and preserve their ability to perform daily activities. This research is important because hand arthritis can make everyday tasks-like opening jars, getting dressed, or gardening-painful and difficult. Current resources for managing arthritis often lack a focus on practical, evidence-based strategies tailored to the needs of people with hand arthritis.

This feasibility study will test the practicality of running a future full-scale randomized controlled trial and the acceptability of the intervention. The feasibility testing includes evaluating key trial processes such as recruitment rates (how many people agree to participate), randomization (how well participants are assigned to groups), attrition rates (how many people stay in the study until the end), adherence (whether participants follow the program as intended), and clinical outcome completion rates (how many participants complete the required assessments). The acceptability of the intervention will be assessed through a survey that will be administered to the intervention group at the end of the trial, which will be based on a standardized acceptability framework. Importantly, this study will not assess the effectiveness of the program, as it is not designed or powered to do so. Instead, the information gathered will be used to refine the trial design and ensure the future full-scale trial is robust and successful.

Eligibility criteria: Inclusion Criteria:

Diagnosis of hand osteoarthritis Pain symptoms for at least 3 months Ability to use a smartphone, tablet, or computer Ability to communicate in English

Exclusion Criteria:

Presence of neurological disorders, dementia, or other cognitive conditions that could interfere with trial procedures Scheduled hand surgery within the next 3 months

Primary outcomes:
measure: Recruitment Rates
timeFrame: 4, 8, and 12-weeks after randomization
measure: Adherence
timeFrame: 4, 8, and 12-weeks after randomization
measure: Clinical outcome measure completion
timeFrame: baseline, 4, 8, and 12-weeks after randomization
measure: Attrition Rates
timeFrame: 4, 8, and 12-weeks after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Roth | McFarlane Hand and Upper Limb Centre (HULC)
state: Ontario
Study officials:
References: