Shoulder OsteoarthritisTRAPPNCT06520085
Optimizing Recovery After Reverse Shoulder Arthroplasty With a Personalized Mobile Health Application
A study testing interactive mHealth application for patients undergoing RSA in people with Shoulder Osteoarthritis, run by VieCuri Medical Centre at 2 sites in Netherlands.
Trial summary
Background: Mobile health (mHealth) - the use of medical applications in healthcare settings - include tools that can support self-management after surgery and thereby contribute to early postoperative recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Osteoarthritis
- What is being tested?
- interactive mHealth application for patients undergoing RSA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Sep 2024to 31 Dec 2027
- 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
- adults undergoing elective reverse shoulder arthroplasty
Who cannot join
- 1) do not own or are not able to operate a smart device; 2) are scheduled for revision surgery; 3) have a fracture as primary diagnosis; 4) an additional muscle transfer needs to be performed; or 5) are unable to read and understand the Dutch language.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Recruiting
Anna ziekenhuis
Geldrop
Anke Kornuijt, MSc, 0031 40 2864278, A.Kornuijt@st-anna.nl
- Recruiting
VieCuri Medisch Centrum
Venlo, Limburg, 5912BL
Esther Janssen, PhD, 0031 77 320 5129, estherjanssen@viecuri.nl
Janneke Crutsen, MSc, jcrutsen@viecuri.nl
About this study
Background: Mobile health (mHealth) - the use of medical applications in healthcare settings - include tools that can support self-management after surgery and thereby contribute to early postoperative recovery. Providing patients with timely and interactive information through mHealth is hypothesized to positively influence recovery after reverse shoulder arthroplasty (RSA).
Aim: The aim of this study is to determine the effectiveness of interactive and personalized information and rehabilitation protocol with a mobile application compared to generic information and generic rehabilitation protocol (standard care) on postoperative recovery in patients undergoing primary RSA.
Methods and analysis: A multicentre randomised controlled trial will be conducted in two Dutch hospitals. In total 170 patients undergoing elective, primary RSA will be included. Participants will be randomly allocated to one of the two groups on a 1:1 ratio. The intervention group will receive interactive postoperative information on a daily basis. The control group will receive standard care. The primary outcome is defined as functional recovery measured using the Oxford Shoulder Score (OSS) at 6 weeks. Secondary outcomes are: pain, physical functioning, quality of life, length of stay, complications, treatment satisfaction and app use. The between group difference will be analysed using linear mixed-effects regression.
- Conditions
- Shoulder Osteoarthritis
- Being tested
- interactive mHealth application for patients undergoing RSA
- Keywords
- Reverse Shoulder Arthroplasty, mHealth, Perioperative Care, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive mHealth application for patients undergoing RSAOther
Patients will receive interactive information via an mHealth application tailored to their needs and progress during the rehabilitation period after RSA.
| Study group | Role | What they receive |
|---|---|---|
| Personalized rehabilitation program | Experimental | The intervention group receives an interactive app that is different from the control is different from the control group in that it provides interactive and personalized information and a personalized rehabilitation program. Both the timing and the amount and nature of the exercises are personalized. Receives: Other: interactive mHealth application for patients undergoing RSA |
| Standard care | Active comparator | The control group will receive postoperative information and a rehabilitation program via the non-interactive application, which is current standard care Receives: Other: interactive mHealth application for patients undergoing RSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative shoulder functioning
Shoulder functioning measured with the Oxford Shoulder Score
Measured: bssix weeks, three months and 1 year
Secondary outcomes (6)
Shoulder pain
Shoulder pain measured using the Numeric Rating Scale
Measured: baseline, daily during the first 6 weeks, 3 months and 1 year
Shoulder disability
shoulder disability measured using the Disability of the Arm, Shoulder and Hand
Measured: baseline, six weeks, three months and 1 year
Range of Motion of the Shoulder
Range of Motion of the Shoulder measured with the goniometer
Measured: baseline, six weeks, three months and 1 year
Satisfaction with the Application
Satisfaction with the Application measured with a five-point likert scale
Measured: six weeks, three months and 1 year
Readmission rate
Readmission rate related to RSA
Measured: 1 year
Complication rate
Complication rate related to RSA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Sep 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder 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
- This study is a multicentre, single-blinded (assessor), two-armed, parallel-group RCT designed to evaluate the effectiveness of a an interactive mHealth application to standard care (non-interactive app) in the rehabilitation period of patients undergoing RSA.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VieCuri Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- St. Anna Ziekenhuis, Geldrop, Netherlands
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06520085
- Sponsor's protocol ID
- TRAPP
- Other IDs
- N22.075
- Acronym
- TRAPP
- Status last verified
- Aug 2026
- First submitted
- 5 Jul 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD may be requested through the contact person. Upon reasonable request these may be provided on a case by case basis.
Publications
Crutsen JRW, Heerspink FOL, Kornuijt A, Ascencio J, van der Weegen W, Timmers T, Craamer C, van Raay JJAM, Hollman F, Janssen ERC. Optimizing recovery after reverse shoulder arthroplasty with a personalised mobile health application compared to generic digital information: a protocol of a multicentre randomised controlled trial. BMC Musculoskelet Disord. 2025 Jul 4;26(1):642. doi: 10.1186/s12891-025-08857-9.
PubMed 40616068
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Recovery After Reverse Shoulder Arthroplasty With a Personalized Mobile Health Application
- ClinicalTrials.gov ID
- NCT06520085
- Acronym / sponsor ID
- TRAPP / TRAPP
- Conditions
- Shoulder Osteoarthritis
- Keywords
- Reverse Shoulder Arthroplasty, mHealth, Perioperative Care, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- VieCuri Medical CentreUniversity, hospital or other
- Collaborators
- St. Anna Ziekenhuis, Geldrop, Netherlands
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jul 2024 (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.
Background: Mobile health (mHealth) - the use of medical applications in healthcare settings - include tools that can support self-management after surgery and thereby contribute to early postoperative recovery. Providing patients with timely and interactive information through mHealth is hypothesized to positively influence recovery after reverse shoulder arthroplasty (RSA).
Aim: The aim of this study is to determine the effectiveness of interactive and personalized information and rehabilitation protocol with a mobile application compared to generic information and generic rehabilitation protocol (standard care) on postoperative recovery in patients undergoing primary RSA.
Methods and analysis: A multicentre randomised controlled trial will be conducted in two Dutch hospitals. In total 170 patients undergoing elective, primary RSA will be included. Participants will be randomly allocated to one of the two groups on a 1:1 ratio. The intervention group will receive interactive postoperative information on a daily basis. The control group will receive standard care. The primary outcome is defined as functional recovery measured using the Oxford Shoulder Score (OSS) at 6 weeks. Secondary outcomes are: pain, physical functioning, quality of life, length of stay, complications, treatment satisfaction and app use. The between group difference will be analysed using linear mixed-effects regression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a multicentre, single-blinded (assessor), two-armed, parallel-group RCT designed to evaluate the effectiveness of a an interactive mHealth application to standard care (non-interactive app) in the rehabilitation period of patients undergoing RSA.
| Arm | Type | Receives |
|---|---|---|
| Personalized rehabilitation program | Experimental | Other: interactive mHealth application for patients undergoing RSAThe intervention group receives an interactive app that is different from the control is different from the control group in that it provides interactive and personalized information and a personalized rehabilitation program. Both the timing and the amount and nature of the exercises are personalized. |
| Standard care | Active comparator | Other: interactive mHealth application for patients undergoing RSAThe control group will receive postoperative information and a rehabilitation program via the non-interactive application, which is current standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults undergoing elective reverse shoulder arthroplasty
Key exclusion criteria (1 listed)
- 1) do not own or are not able to operate a smart device; 2) are scheduled for revision surgery; 3) have a fracture as primary diagnosis; 4) an additional muscle transfer needs to be performed; or 5) are unable to read and understand the Dutch language.
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 |
|---|---|---|
| interactive mHealth application for patients undergoing RSAPatients will receive interactive information via an mHealth application tailored to their needs and progress during the rehabilitation period after RSA. | Other | Personalized rehabilitation program, Standard care |
Primary outcome
Postoperative shoulder functioning
Time frame: bssix weeks, three months and 1 year
Shoulder functioning measured with the Oxford Shoulder Score
6 secondary outcomes
Shoulder pain
Time frame: baseline, daily during the first 6 weeks, 3 months and 1 year
Shoulder disability
Time frame: baseline, six weeks, three months and 1 year
Range of Motion of the Shoulder
Time frame: baseline, six weeks, three months and 1 year
Satisfaction with the Application
Time frame: six weeks, three months and 1 year
Readmission rate
Time frame: 1 year
Complication rate
Time frame: 1 year
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 24 Aug 2026.
- Derived from this study: PubMed 40616068Crutsen JRW, Heerspink FOL, Kornuijt A, Ascencio J, van der Weegen W, Timmers T, Craamer C, van Raay JJAM, Hollman F, Janssen ERC. Optimizing recovery after reverse shoulder arthroplasty with a personalised mobile health application compared to generic digital information: a protocol of a multicentre randomised controlled trial. BMC Musculoskelet Disord. 2025 Jul 4;26(1):642. doi: 10.1186/s12891-025-08857-9.
- Individual participant dataSharing planned: No. IPD may be requested through the contact person. Upon reasonable request these may be provided on a case by case basis.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interactive mHealth application for patients undergoing RSA in people with Shoulder Osteoarthritis, run by VieCuri Medical Centre at 2 sites in Netherlands.
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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative shoulder functioning (time frame: bssix weeks, three months and 1 year). 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 NCT06520085, which also lists 1 linked publication.
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 24 Aug 2026.