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 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:

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Feasibility Studies
• Intervention / Treatment: Other: Digital patient education mobile application.; Other: Standard Care (in control arm)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland
    • Coxa, Hospital for Joint Replacement
    • Contact: Laura Moisio; Phone Number: +358405577146; Email: laura.moisio@tuni.fi
    • Contact: Sari Himanen; Phone Number: +35850 3732 949; Email: sari.himanen@coxa.fi
    • Principal Investigator: Laura Moisio, MHSc, Tampere University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Receives patient education via a mobile application.	Other: 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.
Active Comparator: Control group; Receives traditional patient education during face-to-face clinic visits or by telephone.	Other: Standard Care (in control arm); Patient education provided verbally either face-to-face or by telephone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery
Changes in pain scale measurement	NRS, Numeral Rating Scale.	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)	2 months before surgery and 3 months after surgery
Changes in patient reported outcome measures scores (PROMs), Functional improvement	Oxford Hip Score (OHS)	2 months before surgery and 3 months after surgery

Collaborators and Investigators

• Sponsor: Coxa, Hospital for Joint Replacement
• Collaborators: Tampere University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: R25097H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data collected in the study will not be shared with anyone other than individuals working on the study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No