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).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Tampere, Finland
- Coxa, Hospital for Joint Replacement
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Contact:
- Laura Moisio
- Telefoonnummer: +358405577146
- E-mail: laura.moisio@tuni.fi
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Contact:
- Sari Himanen
- Telefoonnummer: +35850 3732 949
- E-mail: sari.himanen@coxa.fi
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Hoofdonderzoeker:
- Laura Moisio, MHSc, Tampere University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Feasibility and Acceptability
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Expected Knowledge of Hospital Patients, EKhp (©Leino-Kilpi, Salanterä, Hölttä 2003)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R25097H
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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