ClinicalTrials.gg
Active, not recruitingNCT07589803Updated Nov 10, 2026

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.

An interventional study of Digital patient education mobile application. and Standard Care (in control arm) in Feasibility Studies, sponsored by Coxa, Hospital for Joint Replacement. Active, not recruiting at 1 site in Finland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Coxa, Hospital for Joint Replacement · Not applicable, Interventional, and Health services research

Updated Nov 10, 2026Now Active, not recruitingStart date moved+1 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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:

  1. 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?
  2. 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).

02

Conditions studied

  • Feasibility Studies
03

In context

Lead sponsor

Coxa, Hospital for Joint Replacement is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary knee or hip joint replacement surgery
  • No previous visits to Coxa
  • Age 18-75 years
  • Proficiency in the Finnish language
  • (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 ()
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Mobile application

    Receives patient education via a mobile application.

    Other: Digital patient education mobile application.

  • Active comparator
    Traditional patient education

    Receives traditional patient education during face-to-face clinic visits or by telephone.

    Other: Standard Care (in control arm)

Interventions

  • OtherDigital 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.

  • OtherStandard Care (in control arm)

    Patient education provided verbally either face-to-face or by telephone.

06

What researchers measure

Primary outcomes

  1. 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.

    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

Secondary outcomes

  1. 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.

    Time frame: Baseline, before randomization

  2. 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.

    Time frame: 2 weeks before surgery and 4-8 weeks after surgery

  3. 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).

    Time frame: Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery

  4. Changes in pain scale measurement

    NRS, Numeral Rating Scale.

    Time frame: Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery

  5. Changes in patient reported outcome measures scores (PROMs), Functional improvement

    Oxford Knee Score (OKS)

    Time frame: 2 months before surgery and 3 months after surgery

  6. Changes in patient reported outcome measures scores (PROMs), Functional improvement

    Oxford Hip Score (OHS)

    Time frame: 2 months before surgery and 3 months after surgery

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Data collected in the study will not be shared with anyone other than individuals working on the study.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started May 2026 (actual). Primary completion is estimated for Aug 2027, 15 months after the start.

Start moved once since we started tracking on Sep 25, 2026: Apr 2026 → May 2026, on Nov 10, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 11, 2026
First posted
May 15, 2026
StartActual
May 15, 2026was Apr 2026
Primary completionEst.
Aug 2027
CompletionEst.
Dec 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Active, not recruiting
changed Nov 10, 2026
Start date
Apr 2026→May 15, 2026 (actual)
Nov 10, 2026
Interventions
Arm changed Intervention group→Mobile application; Control group→Traditional patient education
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Not yet recruiting→Active, not recruiting
    Start date Apr 2026→May 15, 2026 (now actual)
    Interventions Arm changed Intervention group→Mobile application; Control group→Traditional patient education
    + 4 other changes: verification date, oversight details, criteria formatting and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07589803
Lead sponsor
Coxa, Hospital for Joint Replacement
Collaborators
Tampere University
Responsible party
Laura Moisio (Principal investigator, Coxa, Hospital for Joint Replacement) — Principal investigator
First posted
May 15, 2026
Start date
May 15, 2026
Primary completion
Aug 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 10, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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