Feasibility StudiesNCT07589803
The Aim of This Study is to Assess the Feasibility of the Study Protocol and the Acceptability of the Mobile Application-Based Intervention. The Results Will Guide the Design and Evaluation of a Definitive, Larger-scale Study to Further Examine the Efficacy of the Refined Intervention.
A study testing Digital patient education mobile application. in people with Feasibility Studies, run by Coxa, Hospital for Joint Replacement at 1 site in Finland.
Trial summary
This study is a pilot study for a larger future research project aimed at examining the effects of patient education delivered via a mobile application on patients' self-reported receipt of information in relation to their information needs, as well as on patient-reported quality of life, pain, and functional… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Feasibility Studies
- What is being tested?
- Digital patient education mobile application.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2026to 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary knee or hip joint replacement surgery No previous visits to Coxa Age 18-75 years Proficiency in the Finnish language Body mass index (BMI) below 40 Moderate alcohol consumption (AUDIT < 20) Ability to use a mobile application (access to a compatible smartphone) The patient may have a mild systemic disease that does not significantly limit functional capacity (ASA I-II) The patient may also have a somewhat more severe condition, provided that underlying diseases are well controlled (ASA III) Medication use is moderate, consisting of 1-5 medications in addition to pain medication No use of anticoagulant medication No previously identified anesthetic complications
Who cannot join
- Previous joint surgery Functional impairment / disability Insufficient proficiency in the Finnish language No possibility to use a mobile application (no mobile phone) Patient with multiple comorbidities (multimorbid patient) The patient does not proceed to the surgical waiting list
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
Coxa, Hospital for Joint Replacement
Tampere
Laura Moisio, +358405577146, laura.moisio@tuni.fi
Sari Himanen, +35850 3732 949, sari.himanen@coxa.fi
About this study
Official title: A Mobile Application Intervention Under the Guidance of a Patient Undergoing Total Joint Replacement Surgery- a Pilot Randomized Controlled Trial.
This study is a pilot study for a larger future research project aimed at examining the effects of patient education delivered via a mobile application on patients' self-reported receipt of information in relation to their information needs, as well as on patient-reported quality of life, pain, and functional capacity, compared with traditional patient education provided during in-person appointments or by telephone. The primary objective of this pilot study is to assess the feasibility of conducting the forthcoming larger-scale study.
Research questions:
Read more
- How does patient education delivered via a mobile application meet the information needs of patients undergoing joint replacement surgery, and is the intervention feasible to implement in a larger research setting?
- How do the instruments used in the pilot study (EKhp/RKhp, EQ-5D-5L, NRS, and OKS/OHS) and the study design function when delivered via a mobile application for the intervention group and in conjunction with traditional patient education for the control group, and are the instruments and study design suitable for conducting a larger-scale study.
The study will be conducted as a randomized controlled trial (RCT). Patients will be allocated into two groups:
Intervention group: receives patient education via a mobile application. Control group: receives traditional patient education during face-to-face clinic visits or by telephone.
Data will be collected using questionnaires before surgery (three measurement points) and after surgery (two measurement points).
- Conditions
- Feasibility Studies
- Being tested
- Digital patient education mobile application., Standard Care (in control arm)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital patient education mobile application.Other
The mobile application intervention is delivered via a free smartphone application provided by Buddy Healthcare Ltd Oy. The application contains digital patient education material for patients undergoing total joint replacement surgery, corresponding in content to the printed Patient Guide.
Standard Care (in control arm)Other
Patient education provided verbally either face-to-face or by telephone.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Receives patient education via a mobile application. Receives: Other: Digital patient education mobile application. |
| Control group | Active comparator | Receives traditional patient education during face-to-face clinic visits or by telephone. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Acceptability
Primary outcome measures focus on evaluating the feasibility and acceptability of the intervention by assessing recruitment, adherence, acceptability, and fidelity. Recruitment will be evaluated by determining the proportion of patients who meet the eligibility criteria and the proportion of eligible patients who consent to participate. Adherence will be assessed by examining the proportion of participants who complete all questionnaires and the proportion who do not contribute data due to drop-out. Acceptability will be explored in terms of how well the study design and intervention content are received by participants. Fidelity will be evaluated by assessing how closely the intervention content is delivered as intended.
Measured: A repeated measures design will be conducted; at baseline, 2 months before surgery, 1-2 weeks before surgery , 4-8 weeks after surgery and 3 months after surgery
Secondary outcomes (6)
Expected Knowledge of Hospital Patients, EKhp (©Leino-Kilpi, Salanterä, Hölttä 2003)
A 40-item self-report questionnaire. The instrument based on six knowledge dimensions: biophysiological, functional, experiential, ethical, social, and financial knowledge. Items are on a scale from 0 to 4. All scale scores will be reversed from the original order to facilitate interpretation in statistical analyses (original: 1 = "strongly agree" and 4 = "strongly disagree"; reversed: 4 = "strongly agree" and 1 = "strongly disagree"). Higher scores indicate greater expectations of patient information.
Measured: Baseline, before randomization
Received Knowledge of Hospital Patients, RKhp (©Leino-Kilpi, Salanterä, Hölttä 2003)
A 40-item self-report questionnaire. The instrument based on six knowledge dimensions: biophysiological, functional, experiential, ethical, social, and financial knowledge. Items are on a scale from 0 to 4. All scale scores will be reversed from the original order to facilitate interpretation in statistical analyses (original: 1 = "strongly agree" and 4 = "strongly disagree"; reversed: 4 = "strongly agree" and 1 = "strongly disagree"). Higher scores indicate higher level of information received.
Measured: 2 weeks before surgery and 4-8 weeks after surgery
Changes in health-related quality of life
Quality of life on the EuroQoL-5 Dimensions EQ-5D-5L. The measure is standardised instrument looking at quality of life across five health domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
Measured: Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery
Changes in pain scale measurement
NRS, Numeral Rating Scale.
Measured: Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery
Changes in patient reported outcome measures scores (PROMs), Functional improvement
Oxford Knee Score (OKS)
Measured: 2 months before surgery and 3 months after surgery
Changes in patient reported outcome measures scores (PROMs), Functional improvement
Oxford Hip Score (OHS)
Measured: 2 months before surgery and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study startApr 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility StudiesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coxa, Hospital for Joint Replacement
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Principal investigator, Laura Moisio, Coxa, Hospital for Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589803
- Sponsor's protocol ID
- R25097H
- Status last verified
- Apr 2026
- First submitted
- 11 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected in the study will not be shared with anyone other than individuals working on the study.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Application Intervention Under the Guidance of a Patient Undergoing Total Joint Replacement Surgery- a Pilot Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07589803
- Acronym / sponsor ID
- R25097H
- Conditions
- Feasibility Studies
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Coxa, Hospital for Joint ReplacementUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- Apr 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 May 2026 (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.
This study is a pilot study for a larger future research project aimed at examining the effects of patient education delivered via a mobile application on patients' self-reported receipt of information in relation to their information needs, as well as on patient-reported quality of life, pain, and functional capacity, compared with traditional patient education provided during in-person appointments or by telephone. The primary objective of this pilot study is to assess the feasibility of conducting the forthcoming larger-scale study.
Research questions:
- How does patient education delivered via a mobile application meet the information needs of patients undergoing joint replacement surgery, and is the intervention feasible to implement in a larger research setting?
- How do the instruments used in the pilot study (EKhp/RKhp, EQ-5D-5L, NRS, and OKS/OHS) and the study design function when delivered via a mobile application for the intervention group and in conjunction with traditional patient education for the control group, and are the instruments and study design suitable for conducting a larger-scale study.
The study will be conducted as a randomized controlled trial (RCT). Patients will be allocated into two groups:
Intervention group: receives patient education via a mobile application. Control group: receives traditional patient education during face-to-face clinic visits or by telephone.
Data will be collected using questionnaires before surgery (three measurement points) and after surgery (two measurement points).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Digital patient education mobile application.Receives patient education via a mobile application. |
| Control group | Active comparator | Other: Standard Care (in control arm)Receives traditional patient education during face-to-face clinic visits or by telephone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary knee or hip joint replacement surgery No previous visits to Coxa Age 18-75 years Proficiency in the Finnish language Body mass index (BMI) below 40 Moderate alcohol consumption (AUDIT < 20) Ability to use a mobile application (access to a compatible smartphone) The patient may have a mild systemic disease that does not significantly limit functional capacity (ASA I-II) The patient may also have a somewhat more severe condition, provided that underlying diseases are well controlled (ASA III) Medication use is moderate, consisting of 1-5 medications in addition to pain medication No use of anticoagulant medication No previously identified anesthetic complications
Key exclusion criteria (1 listed)
- Previous joint surgery Functional impairment / disability Insufficient proficiency in the Finnish language No possibility to use a mobile application (no mobile phone) Patient with multiple comorbidities (multimorbid patient) The patient does not proceed to the surgical waiting list
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 |
|---|---|---|
| Digital patient education mobile application.The mobile application intervention is delivered via a free smartphone application provided by Buddy Healthcare Ltd Oy. The application contains digital patient education material for patients undergoing total joint replacement surgery, corresponding in content to the printed Patient Guide. | Other | Intervention group |
| Standard Care (in control arm)Patient education provided verbally either face-to-face or by telephone. | Other | Control group |
Primary outcome
Feasibility and Acceptability
Time frame: A repeated measures design will be conducted; at baseline, 2 months before surgery, 1-2 weeks before surgery , 4-8 weeks after surgery and 3 months after surgery
Primary outcome measures focus on evaluating the feasibility and acceptability of the intervention by assessing recruitment, adherence, acceptability, and fidelity. Recruitment will be evaluated by determining the proportion of patients who meet the eligibility criteria and the proportion of eligible patients who consent to participate. Adherence will be assessed by examining the proportion of participants who complete all questionnaires and the proportion who do not contribute data due to drop-out. Acceptability will be explored in terms of how well the study design and intervention content are received by participants. Fidelity will be evaluated by assessing how closely the intervention content is delivered as intended.
6 secondary outcomes
Expected Knowledge of Hospital Patients, EKhp (©Leino-Kilpi, Salanterä, Hölttä 2003)
Time frame: Baseline, before randomization
Received Knowledge of Hospital Patients, RKhp (©Leino-Kilpi, Salanterä, Hölttä 2003)
Time frame: 2 weeks before surgery and 4-8 weeks after surgery
Changes in health-related quality of life
Time frame: Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery
Changes in pain scale measurement
Time frame: Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery
Changes in patient reported outcome measures scores (PROMs), Functional improvement
Time frame: 2 months before surgery and 3 months after surgery
Changes in patient reported outcome measures scores (PROMs), Functional improvement
Time frame: 2 months before surgery and 3 months after surgery
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 15 May 2026.
- Individual participant dataSharing planned: No. Data collected in the study will not be shared with anyone other than individuals working on the study.
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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 Digital patient education mobile application. in people with Feasibility Studies, run by Coxa, Hospital for Joint Replacement at 1 site in Finland.
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 15 May 2026. 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 Finland. 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?
Feasibility and Acceptability (time frame: A repeated measures design will be conducted; at baseline, 2 months before surgery, 1-2 weeks before surgery , 4-8 weeks after surgery and 3 months after surgery). 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 15 May 2026.