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.

NCT07589803 | Not Yet Recruiting

• 1 other identifier: R25097H
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Feasibility Studies

Outcome Measures

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.

  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)

  Baseline, before randomization

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

  2 weeks before surgery and 4-8 weeks after surgery

• Changes in health-related quality of life

  Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery

• Changes in pain scale measurement

  Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery

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

  2 months before surgery and 3 months after surgery

Study Arms (2)

Intervention group

EXPERIMENTAL

Receives patient education via a mobile application.

Other: Digital patient education mobile application.

Control group

ACTIVE COMPARATOR

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

Other: Standard Care (in control arm)

Interventions

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.

Intervention group

Standard Care (in control arm) OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coxa, Hospital for Joint Replacement: lead
• Tampere University: collaborator

Study Sites (1)

Coxa, Hospital for Joint Replacement

Tampere, Finland

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)