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).
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Tampere、フィンランド
- Coxa, Hospital for Joint Replacement
-
コンタクト：
- Laura Moisio
- 電話番号：+358405577146
- メール：laura.moisio@tuni.fi
-
コンタクト：
- Sari Himanen
- 電話番号：+35850 3732 949
- メール：sari.himanen@coxa.fi
-
主任研究者：
- Laura Moisio, MHSc, Tampere University
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention group
Receives patient education via a 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.
|
|
アクティブコンパレータ：Control group
Receives traditional patient education during face-to-face clinic visits or by telephone.
|
Patient education provided verbally either face-to-face or by telephone.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Feasibility and Acceptability
時間枠：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
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Expected Knowledge of Hospital Patients, EKhp (©Leino-Kilpi, Salanterä, Hölttä 2003)
時間枠：Baseline, before randomization
|
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.
|
Baseline, before randomization
|
|
Received Knowledge of Hospital Patients, RKhp (©Leino-Kilpi, Salanterä, Hölttä 2003)
時間枠：2 weeks before surgery and 4-8 weeks after surgery
|
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.
|
2 weeks before surgery and 4-8 weeks after surgery
|
|
Changes in health-related quality of life
時間枠：Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery
|
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).
|
Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery
|
|
Changes in pain scale measurement
時間枠：Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery
|
NRS, Numeral Rating Scale.
|
Baseline, 1-2 weeks before surgery , 4-8 weeks after surgery
|
|
Changes in patient reported outcome measures scores (PROMs), Functional improvement
時間枠：2 months before surgery and 3 months after surgery
|
Oxford Knee Score (OKS)
|
2 months before surgery and 3 months after surgery
|
|
Changes in patient reported outcome measures scores (PROMs), Functional improvement
時間枠：2 months before surgery and 3 months after surgery
|
Oxford Hip Score (OHS)
|
2 months before surgery and 3 months after surgery
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- R25097H
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。