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.

Официальное название

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

Обзор

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).

Вмешательства

• Другое 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.
• Другое Standard Care (in control arm)
  Patient education provided verbally either face-to-face or by telephone.

Первичные конечные точки

• Feasibility and Acceptability [Срок оценки: 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]

Вторичные конечные точки (6)

• Expected Knowledge of Hospital Patients, EKhp (©Leino-Kilpi, Salanterä, Hölttä 2003) [Срок оценки: Baseline, before randomization]
• Received Knowledge of Hospital Patients, RKhp (©Leino-Kilpi, Salanterä, Hölttä 2003) [Срок оценки: 2 weeks before surgery and 4-8 weeks after surgery]
• Changes in health-related quality of life [Срок оценки: Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery]
• Changes in pain scale measurement [Срок оценки: Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery]
• Changes in patient reported outcome measures scores (PROMs), Functional improvement [Срок оценки: 2 months before surgery and 3 months after surgery]
• Changes in patient reported outcome measures scores (PROMs), Functional improvement [Срок оценки: 2 months before surgery and 3 months after surgery]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Финляндия · 1 центр

• Coxa, Hospital for Joint Replacement — Tampere

Идентификаторы

NCT: NCT07589803 · R25097H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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