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.
A Mobile Application Intervention Under the Guidance of a Patient Undergoing Total Joint Replacement Surgery- a Pilot Randomized Controlled Trial.
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:
- 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?
- 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).
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Tampere、芬兰
- Coxa, Hospital for Joint Replacement
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接触：
- Laura Moisio
- 电话号码：+358405577146
- 邮箱：laura.moisio@tuni.fi
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接触：
- Sari Himanen
- 电话号码：+35850 3732 949
- 邮箱：sari.himanen@coxa.fi
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首席研究员：
- Laura Moisio, MHSc, Tampere University
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention group
Receives patient education via a mobile application.
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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.
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有源比较器：Control group
Receives traditional patient education during face-to-face clinic visits or by telephone.
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Patient education provided verbally either face-to-face or by telephone.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility and Acceptability
大体时间：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
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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.
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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
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Expected Knowledge of Hospital Patients, EKhp (©Leino-Kilpi, Salanterä, Hölttä 2003)
大体时间：Baseline, before randomization
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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.
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Baseline, before randomization
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Received Knowledge of Hospital Patients, RKhp (©Leino-Kilpi, Salanterä, Hölttä 2003)
大体时间：2 weeks before surgery and 4-8 weeks after surgery
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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.
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2 weeks before surgery and 4-8 weeks after surgery
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Changes in health-related quality of life
大体时间：Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery
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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).
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Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery
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Changes in pain scale measurement
大体时间：Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery
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NRS, Numeral Rating Scale.
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Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery
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Changes in patient reported outcome measures scores (PROMs), Functional improvement
大体时间：2 months before surgery and 3 months after surgery
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Oxford Knee Score (OKS)
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2 months before surgery and 3 months after surgery
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Changes in patient reported outcome measures scores (PROMs), Functional improvement
大体时间：2 months before surgery and 3 months after surgery
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Oxford Hip Score (OHS)
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2 months before surgery and 3 months after surgery
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- R25097H
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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