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Back to study searchNCT07589803
Active, not recruitingNCT07589803ClinicalTrials.gov record

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.

Feasibility Studies

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - 75 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
40 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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).

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

  • 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

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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Double masked
Mobile application

Receives patient education via a mobile application.

Other: Digital patient education mobile application.

Traditional patient education

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

Other: Standard Care (in control arm)

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

Secondary measures

Expected Knowledge of Hospital Patients, EKhp (©Leino-Kilpi, Salanterä, Hölttä 2003)

Time frame: Baseline, before randomization

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.

Received Knowledge of Hospital Patients, RKhp (©Leino-Kilpi, Salanterä, Hölttä 2003)

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

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.

Changes in health-related quality of life

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

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).

Changes in pain scale measurement

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

NRS, Numeral Rating Scale.

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

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

Oxford Knee Score (OKS)

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

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

Oxford Hip Score (OHS)

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Coxa, Hospital for Joint ReplacementTampere, FinlandStatus unknown

Study team and timeline

Lead sponsor
Coxa, Hospital for Joint Replacement
Study start
May 15, 2026 Actual
Primary completion
2027-08 Estimated
Study completion
2027-12 Estimated
First posted
May 15, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

A Mobile Application Intervention Under the Guidance of a Patient Undergoing Total Joint Replacement Surgery- a Pilot Randomized Controlled Trial.

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026