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NCT Number: NCT07589803

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.

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).

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Key information

Conditions

Feasibility Studies

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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).

  4. Changes in pain scale measurement

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

    NRS, Numeral Rating Scale.

  5. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

Coxa, Hospital for Joint Replacement

Other

Collaborators

  • Tampere University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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