The Aim of This Study is to Assess the Feasibility of the Study Protocol and the Acceptability of… (NCT07589803) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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.
Finland40 participantsStarted 2026-04
Plain-language 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).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility and Acceptability
Timeframe: 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