Hand OsteoarthritisHappyHandsNCT05568875
Happy Hands - an E-self-management Intervention for People With Hand Osteoarthritis
A study testing e-self-management intervention (Happy Hands app) and Treatment as usual in people with Hand Osteoarthritis, run by Diakonhjemmet Hospital at 19 sites in Norway.
Trial summary
The main aim of this project is to assess the effect, cost-effectiveness and user experiences with using an e-self-management intervention in addition to treatment as usual compared to treatment as usual alone in patients with hand osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- e-self-management intervention (Happy Hands app) and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 19 sitesNorway
- Study dates
- 8 Nov 2022to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People diagnosed with hand osteoarthritis
- Possessing a smartphone
Who cannot join
- cognitive deficits
- are scheduled for hand surgery within the next 3 months
- do not talk or understand Norwegian,
- have uncontrolled serious comorbidities
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Norway19 sites
Ålesund sjukehus
Ålesund
Arendal sykehus
Arendal
Haukeland Universitetssykehus
Bergen
Aurskog Fysikalske Institutt
Bjørkelangen
Nordlandssykehuset
Bodø
Lærdal Sjukehus
Førde
Finnmarkssykehuset, Kirkenes Sykehus
Kirkenes
Kongsvinger sykehus
Kongsvinger
Kristiansand sykehus
Kristiansand
Levanger sykehus
Levanger
Revmatismesykehuset Lillehammer
Lillehammer
Meråker kurbad
Meråker
Nøtterøy Fysioterapi
Nøtterøy
Diakonhjemmet Hospital
Oslo
Humana Helse
Sandvika
Helsehuset Stokke
Tønsberg
Universitetssykehuset Nord-Norge
Tromsø
St.Olavs Hospital
Trondheim
Vikersund bad
Vikersund
About this study
The main aim of this project is to assess the effect, cost-effectiveness and user experiences with using an e-self-management intervention in addition to treatment as usual compared to treatment as usual alone in patients with hand osteoarthritis. The study is an RCT comprising approx 400 participants with hand osteoarthritis recruited from primary and secondary healthcare in all four health regions in Norway.
Read the detailed description
Hand osteoarthritis (OA) is a highly prevalent rheumatic joint disease, and the number of people living with debilitating hand OA will continue to rise in the coming decades due to increased life expectancy. Research shows that patients with hand OA have poor access to recommended treatment, and in Norway, they are increasingly referred to surgical consultation before having received recommended first-line treatment. Thus, there is a need to develop easily viable models of care for patients with hand OA that make recommended treatment available across different healthcare levels.
Our hypotheses are that an e-self-management intervention for people with hand OA will improve pain and function and be more cost-effective compared to treatment as usual, and that this app can easily be implemented in both specialist and primary healthcare. The hypotheses will be tested and explored in a randomized controlled trial, with a qualitative study nested within this trial.
The main research questions are:
- To evaluate whether a 12-week e-self-management intervention is more effective in improving pain and function (according to the OMERACT-OARSI responder criteria26) compared to usual care in patients with hand OA (randomized controlled trial).
- To determine the cost-effectiveness of the e-self-management intervention compared to usual care after 6 months (randomized controlled trial).
- To explore patients' experience of barriers and facilitators for adopted and continued use of a e-self-management intervention for treatment of hand OA (qualitative interviews).
Secondary research questions will also be assessed.
Approx 400 patients will be recruited in this multicenter randomized controlled trial where patients with hand OA are allocated to either usual care or a 12-week e-self-management intervention delivered through a smartphone app (the HAPPY Hands app). Outcome measures are collected at baseline, 3 months (=end of intervention) and 6 months
- Conditions
- Hand Osteoarthritis
- Being tested
- e-self-management intervention (Happy Hands app), Treatment as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-self-management intervention (Happy Hands app)Other
The 12-week intervention consists of 30 short informational videos addressing the themes prioritized by the patient research partners. These themes are further operationalized into the following categories: "Information on hand OA", "Hand exercises", "Use of assistive devices and orthoses", "Medication and surgical alternatives", and "Self-management of the disease". Additionally, the intervention includes a hand exercise program consisting of 8 videos providing instructions on warm up, exercises to improve mobility, strength and coordination, and a stretching exercise. The intervention group will additionally receive treatment as usual.
Treatment as usualOther
Treatment as usual may vary from no treatment at all to referral to a patient education group program, or occupational therapy.
| Study group | Role | What they receive |
|---|---|---|
| e-self-management intervention | Experimental | 12-week e-self-management intervention consisting of exercise videos and videos with information about recommended treatment Receives: Other: e-self-management intervention (Happy Hands app); Other: Treatment as usual |
| Treatment as usual | Active comparator | Treatment as usual Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
OMERACT/OARSI responder criteria
Combined score of change in pain, function and disease activity. Patients are categorized into responders or non-responders according to the following:
High improvement on pain or function:
- ≥50% improvement + absolute change of ≥2 in pain (numeric rating scale, NRS 0-10), OR
- ≥50% improvement + absolute change of ≥0.6 in function (Measure of Activity Performance of the Hand, MAP-Hand)
Improvement in at least two of the three following:
- ≥20% improvement + absolute change of ≥1 in pain (NRS)
- ≥20% improvement + absolute change of ≥0.3 in function (MAP-Hand)
- ≥20% improvement + absolute change of ≥1 in global assessment of disease activity (NRS)
Measured: Baseline and 3 months follow-up
Secondary outcomes (30)
OMERACT/OARSI responder criteria long-term
Combined score of change in pain, function and disease activity. Patients are categorized into responders or non-responders according to the following:
High improvement on pain or function:
- ≥50% improvement + absolute change of ≥2 in pain (numeric rating scale, NRS 0-10), OR
- ≥50% improvement + absolute change of ≥0.6 in function (Measure of Activity Performance of the Hand, MAP-Hand)
Improvement in at least two of the three following:
- ≥20% improvement + absolute change of ≥1 in pain (NRS)
- ≥20% improvement + absolute change of ≥0.3 in function (MAP-Hand)
- ≥20% improvement + absolute change of ≥1 in global assessment of disease activity (NRS)
Measured: 3 and 6 months follow-up
Pain intensity
Numeric rating scale (0-10), 0=no pain, 10= worst possible pain
Measured: Baseline, 3 and 6 months follow-up
Pain intensity (intervention group)
Numeric rating scale (0-10), 0=no pain, 10= worst possible pain, measured after each exercise session
Measured: 3 times weekly in the intervention period (12 weeks)
Stiffness
Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness
Measured: Baseline, 3 and 6 months follow-up
Stiffness (intervention group)
Numeric rating scale (0-10),0=no stiffness, 10= worst possible stiffness, measured after each exercise session
Measured: 3 times weekly in the intervention period (12 weeks)
Disease activity
Numeric rating scale (0-10), 0=no disease activity; 10=high disease activity
Measured: Baseline, 3 and 6 months follow-up
Disease activity (intervention group)
Numeric rating scale (0-10), 0=no disease activity; 10=high disease activity, measured each month in the intervention period
Measured: Monthly in the intervention period (12 weeks)
Measure of Activity performance (MAP-Hand)
18 questions conserning activity performance of the hand (1=no problem, 4=cannot do the activity), mean score from 1-4.
Measured: Baseline, 3 and 6 months follow-up
Measure of Activity performance (MAP-Hand) (intervention group)
18 questions conserning activity performance of the hand (1=no problem, 4=cannot do the activity), mean score from 1-4.
Measured: Monthly in the intervention period (12 weeks)
Grip strength
Measured with Jamar dynamometer (kg), mean of two measures for each hand
Measured: Baseline and 3 months follow-up
Quality indicators for hand osteoarthritis treatment
Quality indicators based on the OA-QI questionnaire, adopted to fit the treatment recommendations of hand osteoarthritis. 16 questions answered with yes, no or not appriopriate/do not know. Measured as pass rate.
Measured: Baseline, 3 and 6 months follow-up
eHealth literacy
Measured with the eHEALS questionnaire, Norwegian version. 8 questions conserning eHealth literacy (strongly disagree - strongly agree)
Measured: Baseline
Number of painful joints
Number of painful joints on left and right hand
Measured: Baseline
Change in condition
Global rating of change scale, likert scale with 7 answer options from much better to much worse
Measured: Baseline, 3 and 6 months follow-up
Change in condition (intervention group)
Global rating of change scale, likert scale with 7 answer options from much better to much worse
Measured: Monthly in the intervention group (3 months)
Motivation for hand exercises
Numeric rating scale (0-10), 0=no motivation, 10=best motivation
Measured: Baseline and 3 monhts follow-up
Health-related quality of life
Measured with EQ5D-5L, 5 questions used to calculate an utility score (0-1, 1= best health), assessed as a total score across all timepoints
Measured: Baseline, 3 and 6 months follow-up
Health care utilization
Costs related to self-reported healthcare use in primary and secondary health care. Patients will be asked if they have been seeking healthcare (yes/no), if yes, they will be asked to specify type of healthcare use and time used.
Measured: Baseline, 3 and 6 months follow-up
Medication use
Medication use will be self-reported by the patient
Measured: Baseline, 3 and 6 months follow-up
Adverse events
Number of adverse events, serious adverse events, and withdrawals because of adverse events. Will be self-reported
Measured: 3 and 6 months follow-up
Sickleave
Sickleave due to hand osteoarthritis will be self-reported
Measured: Baseline, 3 and 6 months follow-up
Fatigue
Fatigue last week measured on an 11-point NRS (0=no fatigue, 10=worst possible fatigue)
Measured: Baseline, 3 and 6 months follow-up
Patient satisfaction with care
1 item with five point response options ranging from "Very satisfied" to "Very dissatisfied", higher value indicate better outcome
Measured: Baseline, 3 and 6 months follow-up
System Usability Scale (SUS)
Questionnaire assessing the usability of the Happy Hands app, 10 questions (strongly agree - strongly disagree), index from 0-100 where 100 is best score
Measured: 3 month follow-up
Adherence to exercise
Number of exercises performed (0-36 exercise sessions), collected from the app
Measured: 3 times weekly during the intervention period (3 months)
Adherence to exercise long-term
Number of exercises performed after completion of intervention, collected from the app
Measured: 3 and 6 months follow-up
Adherence to informational videos
Number of informational videos watched, collected from the app
Measured: During the intervention period (3 months)
Adherence to informational videos long-term
Number of informational videos watched, collected from the app
Measured: 3 and 6 months follow-up
Arthritis self-efficacy scale
Measured by Arthritis Self-Efficacy Scale (ASES): comprises 11 items addressing pain and symptoms (scored on a 5-point scale ranging from not confident at all to very confident). The scores are summed up to a 0-100 score where higher score indicate better self-efficacy.
Measured: Baseline
Demographic variable
Age, gender, other painful joints, sivil status, education, previous hand surgery, previous treatment, comorbidities
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start8 Nov 2022
- Primary completion1 Sep 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Model description
- Multicenter randomized controlled trial with a qualitative study nested within the trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diakonhjemmet Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Dam Foundation
- Responsible party
- Principal investigator, Anne Therese Tveter, Diakonhjemmet Hospital
- Investigators
- Anne Therese Tveter, PhD, Principal investigator, Diakonhjemmet Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568875
- Sponsor's protocol ID
- REK 477746
- Acronym
- HappyHands
- Status last verified
- Apr 2024
- First submitted
- 3 Oct 2022
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data be made available when upon reasonable request to the principal investigator. The data are not available before they can be anonymoused.
Publications
Fjeldstad KA, Tveter AT, Rasmussen E, Olden L, Nyheim S, Blanck T, Killingmo RM, Kjeken I. Changing Habits With the Happy Hands App: Qualitative Focus Group Study of a Hand Osteoarthritis Self-Management Intervention. J Med Internet Res. 2026 Feb 2;28:e82773. doi: 10.2196/82773.
PubMed 41628446Tveter AT, Fjeldstad KA, Varsi C, Maarnes MK, Pedersen SJ, Christensen BS, Blanck T, Nyheim SB, Prior Y, Bjork M, Pelle T, Kjeken I. Evaluation of an e-self-management intervention (Happy Hands app) for hand osteoarthritis: Study protocol for a multicentre randomised controlled trial. Rheumatol Int. 2025 Jan 16;45(1):30. doi: 10.1007/s00296-025-05787-6.
PubMed 39820549
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Happy Hands - an E-self-management Intervention for People With Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT05568875
- Acronym / sponsor ID
- HappyHands / REK 477746
- Conditions
- Hand Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Diakonhjemmet HospitalUniversity, hospital or other
- Collaborators
- The Dam Foundation
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 6 Oct 2022 (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 main aim of this project is to assess the effect, cost-effectiveness and user experiences with using an e-self-management intervention in addition to treatment as usual compared to treatment as usual alone in patients with hand osteoarthritis. The study is an RCT comprising approx 400 participants with hand osteoarthritis recruited from primary and secondary healthcare in all four health regions in Norway.
Detailed description
Hand osteoarthritis (OA) is a highly prevalent rheumatic joint disease, and the number of people living with debilitating hand OA will continue to rise in the coming decades due to increased life expectancy. Research shows that patients with hand OA have poor access to recommended treatment, and in Norway, they are increasingly referred to surgical consultation before having received recommended first-line treatment. Thus, there is a need to develop easily viable models of care for patients with hand OA that make recommended treatment available across different healthcare levels.
Our hypotheses are that an e-self-management intervention for people with hand OA will improve pain and function and be more cost-effective compared to treatment as usual, and that this app can easily be implemented in both specialist and primary healthcare. The hypotheses will be tested and explored in a randomized controlled trial, with a qualitative study nested within this trial.
The main research questions are:
- To evaluate whether a 12-week e-self-management intervention is more effective in improving pain and function (according to the OMERACT-OARSI responder criteria26) compared to usual care in patients with hand OA (randomized controlled trial).
- To determine the cost-effectiveness of the e-self-management intervention compared to usual care after 6 months (randomized controlled trial).
- To explore patients' experience of barriers and facilitators for adopted and continued use of a e-self-management intervention for treatment of hand OA (qualitative interviews).
Secondary research questions will also be assessed.
Approx 400 patients will be recruited in this multicenter randomized controlled trial where patients with hand OA are allocated to either usual care or a 12-week e-self-management intervention delivered through a smartphone app (the HAPPY Hands app). Outcome measures are collected at baseline, 3 months (=end of intervention) and 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Multicenter randomized controlled trial with a qualitative study nested within the trial
| Arm | Type | Receives |
|---|---|---|
| e-self-management intervention | Experimental | Other: e-self-management intervention (Happy Hands app), Other: Treatment as usual12-week e-self-management intervention consisting of exercise videos and videos with information about recommended treatment |
| Treatment as usual | Active comparator | Other: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People diagnosed with hand osteoarthritis
- Possessing a smartphone
Key exclusion criteria (4 listed)
- cognitive deficits
- are scheduled for hand surgery within the next 3 months
- do not talk or understand Norwegian,
- have uncontrolled serious comorbidities
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 |
|---|---|---|
| e-self-management intervention (Happy Hands app)The 12-week intervention consists of 30 short informational videos addressing the themes prioritized by the patient research partners. These themes are further operationalized into the following categories: "Information on hand OA", "Hand exercises", "Use of assistive devices and orthoses", "Medication and surgical alternatives", and "Self-management of the disease". Additionally, the intervention includes a hand exercise program consisting of 8 videos providing instructions on warm up, exercises to improve mobility, strength and coordination, and a stretching exercise. The intervention group will additionally receive treatment as usual. | Other | e-self-management intervention |
| Treatment as usualTreatment as usual may vary from no treatment at all to referral to a patient education group program, or occupational therapy. | Other | Treatment as usual, e-self-management intervention |
Primary outcome
OMERACT/OARSI responder criteria
Time frame: Baseline and 3 months follow-up
Combined score of change in pain, function and disease activity. Patients are categorized into responders or non-responders according to the following: High improvement on pain or function: 1. ≥50% improvement + absolute change of ≥2 in pain (numeric rating scale, NRS 0-10), OR 2. ≥50% improvement + absolute change of ≥0.6 in function (Measure of Activity Performance of the Hand, MAP-Hand) Improvement in at least two of the three following: 1. ≥20% improvement + absolute change of ≥1 in pain (NRS) 2. ≥20% improvement + absolute change of ≥0.3 in function (MAP-Hand) 3. ≥20% improvement + absolute change of ≥1 in global assessment of disease activity (NRS)
30 secondary outcomes
OMERACT/OARSI responder criteria long-term
Time frame: 3 and 6 months follow-up
Pain intensity
Time frame: Baseline, 3 and 6 months follow-up
Pain intensity (intervention group)
Time frame: 3 times weekly in the intervention period (12 weeks)
Stiffness
Time frame: Baseline, 3 and 6 months follow-up
Stiffness (intervention group)
Time frame: 3 times weekly in the intervention period (12 weeks)
Disease activity
Time frame: Baseline, 3 and 6 months follow-up
Disease activity (intervention group)
Time frame: Monthly in the intervention period (12 weeks)
Measure of Activity performance (MAP-Hand)
Time frame: Baseline, 3 and 6 months follow-up
Measure of Activity performance (MAP-Hand) (intervention group)
Time frame: Monthly in the intervention period (12 weeks)
Grip strength
Time frame: Baseline and 3 months follow-up
Quality indicators for hand osteoarthritis treatment
Time frame: Baseline, 3 and 6 months follow-up
eHealth literacy
Time frame: Baseline
Number of painful joints
Time frame: Baseline
Change in condition
Time frame: Baseline, 3 and 6 months follow-up
Change in condition (intervention group)
Time frame: Monthly in the intervention group (3 months)
Motivation for hand exercises
Time frame: Baseline and 3 monhts follow-up
Health-related quality of life
Time frame: Baseline, 3 and 6 months follow-up
Health care utilization
Time frame: Baseline, 3 and 6 months follow-up
Medication use
Time frame: Baseline, 3 and 6 months follow-up
Adverse events
Time frame: 3 and 6 months follow-up
Sickleave
Time frame: Baseline, 3 and 6 months follow-up
Fatigue
Time frame: Baseline, 3 and 6 months follow-up
Patient satisfaction with care
Time frame: Baseline, 3 and 6 months follow-up
System Usability Scale (SUS)
Time frame: 3 month follow-up
Adherence to exercise
Time frame: 3 times weekly during the intervention period (3 months)
Adherence to exercise long-term
Time frame: 3 and 6 months follow-up
Adherence to informational videos
Time frame: During the intervention period (3 months)
Adherence to informational videos long-term
Time frame: 3 and 6 months follow-up
Arthritis self-efficacy scale
Time frame: Baseline
Demographic variable
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Derived from this study: PubMed 41628446Fjeldstad KA, Tveter AT, Rasmussen E, Olden L, Nyheim S, Blanck T, Killingmo RM, Kjeken I. Changing Habits With the Happy Hands App: Qualitative Focus Group Study of a Hand Osteoarthritis Self-Management Intervention. J Med Internet Res. 2026 Feb 2;28:e82773. doi: 10.2196/82773.
- Derived from this study: PubMed 39820549Tveter AT, Fjeldstad KA, Varsi C, Maarnes MK, Pedersen SJ, Christensen BS, Blanck T, Nyheim SB, Prior Y, Bjork M, Pelle T, Kjeken I. Evaluation of an e-self-management intervention (Happy Hands app) for hand osteoarthritis: Study protocol for a multicentre randomised controlled trial. Rheumatol Int. 2025 Jan 16;45(1):30. doi: 10.1007/s00296-025-05787-6.
- Individual participant dataSharing planned: Yes. Individual participant data be made available when upon reasonable request to the principal investigator. The data are not available before they can be anonymoused.
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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. This study is not recruiting at the moment.
Anne Therese Tveter, PhD principal investigator
Diakonhjemmet Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-self-management intervention (Happy Hands app) and Treatment as usual in people with Hand Osteoarthritis, run by Diakonhjemmet Hospital at 19 sites in Norway.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OMERACT/OARSI responder criteria (time frame: Baseline and 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05568875, which also lists 2 linked publications.
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 13 Apr 2025.