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Active Not Recruiting
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.
Conditions: Feasibility Studies
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Coxa, Hospital for Joint Replacement
Location: Coxa, Hospital for Joint Replacement Tampere
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).
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07589803). StuddyBuddy aggregates publicly available trial information.