Hand Osteoarthritis"Helping Hand"NCT06963164
Testing of a New Joint Protection Program
A study testing Helping Hand - Joint Protection Program in people with Hand Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Helping Hand - Joint Protection Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of hand osteoarthritis Pain symptoms for at least 3 months Ability to use a smartphone, tablet, or computer Ability to communicate in English
Who cannot join
- Presence of neurological disorders, dementia, or other cognitive conditions that could interfere with trial procedures Scheduled hand surgery within the next 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Roth | McFarlane Hand and Upper Limb Centre (HULC)
London, Ontario, N6A 4V2
Katrina Munro, MPT, 519-646-6100 ext. 64544, katrina.munro@sjhc.london.on.ca
Dimitra Pouliopoulou, PT, MSc, 519-646-6100 ext. 64544
About this study
Official title: Feasibility of a Remotely-Delivered, Technology-Enabled, Joint Protection Program
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
Read more
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)
Read the 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:
- Using larger, stronger joints whenever possible (e.g., using the forearm instead of the fingers to push open a door).
- Reducing strain by spreading the load across multiple joints (e.g., carrying items with two hands instead of one).
- Avoid tight gripping or pinching motions that can overstrain the joints.
- Incorporating assistive devices to reduce effort during tasks (e.g., jar openers or ergonomic tools).
- 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.
- Conditions
- Hand Osteoarthritis
- Being tested
- Helping Hand - Joint Protection Program
- Keywords
- hand osteoarthritis, randomize controlled trial, feasibility, pilot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helping Hand - Joint Protection ProgramOther
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:
- Using larger, stronger joints whenever possible (e.g., using the forearm instead of the fingers to push open a door).
- Reducing strain by spreading the load across multiple joints (e.g., carrying items with two hands instead of one).
- Avoid tight gripping or pinching motions that can overstrain the joints.
- Incorporating assistive devices to reduce effort during tasks (e.g., jar openers or ergonomic tools).
- Pacing and prioritizing activities to avoid overuse of the joints and allow for adequate rest
| Study group | Role | What they receive |
|---|---|---|
| Joint Protection Program | Experimental | The content will be organised into 6 modules (4 asynchronous, 2 live modules). Each module will focus on specific principles or activities.
The first two modules will present general information on Hand Osteoarthritis and Joint Protection Principles, and the third module will be activity-based and will go through different tasks including Activities of Daily Living, Occupational Activities, Household Chores, Hobbies, and Various Functional Everyday Activities. The fourth module will be pre-recorded, and it will include a patient partner talking about their experiences living with hand osteoarthritis.
The two live modules will happen bi-weekly interchangeably. The first module will be a community of practice, where people will get together and exchange information on tools, strategies, and resources for hand osteoarthritis. The second module will include open Q\&A sessions, where patients will get the chance to talk to a clinician and ask questions about managing hand osteoarthritis. Receives: Other: Helping Hand - Joint Protection Program |
| Waitlist | No intervention | The participants in this group will continue to receive Standard Care and they will be offered access to the program after the end of the 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rates
Pre-defined cut-off scores will be used. Based on the cut-off scores each outcome will be categorised in one of three categories: "proceed"; "proceed with modifications"; and "do not proceed". Recruitment rates will be classified as proceed if they achieve or surpass the predefined threshold set at 8-10 participants on average per month.
Measured: 4, 8, and 12-weeks after randomization
Adherence
Uptake/participation will be tracked electronically by recording when participants log onto the website and monitoring whether participants show up in the live sessions. Adherence will also be measured by having the participants track the weekly modifications they performed through a self-reported diary. Pre-defined cut-off scores will be used. Based on the cut-off scores each outcome will be categorised in one of three categories: "proceed"; "proceed with modifications"; and "do not proceed". Adherence to the intervention protocol will be categorized as "proceed" if it achieves a minimum adherence rate of 85%.
Measured: 4, 8, and 12-weeks after randomization
Clinical outcome measure completion
Pre-defined cut-off scores will be used. Based on the cut-off scores each outcome will be categorised in one of three categories: "proceed"; "proceed with modifications"; and "do not proceed". Outcome completeness will be considered "proceed" when data collection for at least 90% of the intended outcomes is achieved.
Measured: baseline, 4, 8, and 12-weeks after randomization
Attrition Rates
Pre-defined cut-off scores will be used. Based on the cut-off scores each outcome will be categorised in one of three categories: "proceed"; "proceed with modifications"; and "do not proceed". Attrition rates will be classified as "proceed" if they remain below the predefined threshold, typically set at 20% or lower
Measured: 4, 8, and 12-weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study startSep 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- The Arthritis Society, Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963164
- Sponsor's protocol ID
- 15417
- Acronym
- "Helping Hand"
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Remotely-Delivered, Technology-Enabled, Joint Protection Program
- ClinicalTrials.gov ID
- NCT06963164
- Acronym / sponsor ID
- "Helping Hand" / 15417
- Conditions
- Hand Osteoarthritis
- Keywords
- hand osteoarthritis, randomize controlled trial, feasibility, pilot
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- The Arthritis Society, Canada
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Using larger, stronger joints whenever possible (e.g., using the forearm instead of the fingers to push open a door).
- Reducing strain by spreading the load across multiple joints (e.g., carrying items with two hands instead of one).
- Avoid tight gripping or pinching motions that can overstrain the joints.
- Incorporating assistive devices to reduce effort during tasks (e.g., jar openers or ergonomic tools).
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Joint Protection Program | Experimental | Other: Helping Hand - Joint Protection ProgramThe content will be organised into 6 modules (4 asynchronous, 2 live modules). Each module will focus on specific principles or activities. The first two modules will present general information on Hand Osteoarthritis and Joint Protection Principles, and the third module will be activity-based and will go through different tasks including Activities of Daily Living, Occupational Activities, Household Chores, Hobbies, and Various Functional Everyday Activities. The fourth module will be pre-recorded, and it will include a patient partner talking about their experiences living with hand osteoarthritis. The two live modules will happen bi-weekly interchangeably. The first module will be a community of practice, where people will get together and exchange information on tools, strategies, and resources for hand osteoarthritis. The second module will include open Q\&A sessions, where patients will get the chance to talk to a clinician and ask questions about managing hand osteoarthritis. |
| Waitlist | No intervention | –The participants in this group will continue to receive Standard Care and they will be offered access to the program after the end of the 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of hand osteoarthritis Pain symptoms for at least 3 months Ability to use a smartphone, tablet, or computer Ability to communicate in English
Key exclusion criteria (1 listed)
- Presence of neurological disorders, dementia, or other cognitive conditions that could interfere with trial procedures Scheduled hand surgery within the next 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helping Hand - Joint Protection ProgramJoint 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 | Other | Joint Protection Program |
Primary outcome
Recruitment Rates
Time frame: 4, 8, and 12-weeks after randomization
Pre-defined cut-off scores will be used. Based on the cut-off scores each outcome will be categorised in one of three categories: "proceed"; "proceed with modifications"; and "do not proceed". Recruitment rates will be classified as proceed if they achieve or surpass the predefined threshold set at 8-10 participants on average per month.
Adherence
Time frame: 4, 8, and 12-weeks after randomization
Uptake/participation will be tracked electronically by recording when participants log onto the website and monitoring whether participants show up in the live sessions. Adherence will also be measured by having the participants track the weekly modifications they performed through a self-reported diary. Pre-defined cut-off scores will be used. Based on the cut-off scores each outcome will be categorised in one of three categories: "proceed"; "proceed with modifications"; and "do not proceed". Adherence to the intervention protocol will be categorized as "proceed" if it achieves a minimum adherence rate of 85%.
Clinical outcome measure completion
Time frame: baseline, 4, 8, and 12-weeks after randomization
Pre-defined cut-off scores will be used. Based on the cut-off scores each outcome will be categorised in one of three categories: "proceed"; "proceed with modifications"; and "do not proceed". Outcome completeness will be considered "proceed" when data collection for at least 90% of the intended outcomes is achieved.
Attrition Rates
Time frame: 4, 8, and 12-weeks after randomization
Pre-defined cut-off scores will be used. Based on the cut-off scores each outcome will be categorised in one of three categories: "proceed"; "proceed with modifications"; and "do not proceed". Attrition rates will be classified as "proceed" if they remain below the predefined threshold, typically set at 20% or lower
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helping Hand - Joint Protection Program in people with Hand Osteoarthritis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joy MacDermid, PT, PHD (519-646-6000 ext. 64636, jmacderm@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rates (time frame: 4, 8, and 12-weeks after randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.