Ignite Creation Date:
2024-10-25 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606158
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Rehabilitation in Total Hip Arthroplasty Through a Mobile Application
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Rehabilitation in Total Hip Arthroplasty Through a Mobile Application A Retrospective Observational Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HIP-App
Brief Summary:
This observational retrospective study aims to assess the rehabilitation outcomes of patients who underwent total hip arthroplasty THA and were monitored through a mobile application versus those who were not The hypothesis is that patients who receive postoperative follow-up via a mobile app which includes a recovery exercise program will experience significantly greater improvements in functionality quality of life and treatment adherence compared to those who do not use the app after three months of follow-up
The study will analyze the records of patients from two cohorts one group monitored with the mobile application and another group receiving standard postoperative care without the app Data on patients39 functionality quality of life and adherence to treatment will be collected and compared between the two groups This study seeks to provide evidence on the effectiveness of digital health interventions in enhancing postoperative recovery for THA patients
The study will analyze the records of patients from two cohorts one group monitored with the mobile application and another group receiving standard postoperative care without the app Data on patients39 functionality quality of life and adherence to treatment will be collected and compared between the two groups This study seeks to provide evidence on the effectiveness of digital health interventions in enhancing postoperative recovery for THA patients
Detailed Description:
This study adopts an observational analytical longitudinal and retrospective design with two cohorts an exposed cohort and a non-exposed cohort aimed at evaluating the effectiveness of a follow-up program using a mobile application in patients undergoing total hip arthroplasty
Patients selected for this study have undergone total hip arthroplasty using the Furlong Evolution short stem and acetabular cup prosthetic design ACE Surgeries were performed at Hospital San Juan de Dios de Santurtzi and Hospital Universitario de Galdakao both located in Vizcaya
To analyze the new care model functional recovery program and patient follow-up via a digital application the entire study population from June 1 2023 to March 30 2024 will be included conducting a complete cohort analysis with a 3-month follow-up period
Data collection includes sociodemographic clinical and pre-surgical functional characteristics Specific assessment tests were employed to evaluate pain function and quality of life
Electronic health records will be used to collect data including demographic variables age gender medical history Patient-Reported Outcome Measures PROMs such as the Harris Hip Score and WOMAC scale and Patient-Reported-Experience-Mesures PREMs as satisfaction scale
Quality assurance procedures will be implemented to ensure data validity and registry integrity including data validation checks source data verification against external sources and a comprehensive data dictionary detailing each variable39s origin and coding information
Standard Operating Procedures SOPs will guide registry operations including patient recruitment data collection management analysis adverse event reporting and change management
A statistical analysis plan will employ appropriate analytical principles and techniques to address primary and secondary objectives outlined in the study protocol assessing the sample size required to demonstrate significant effects and strategies for handling missing data
This detailed description encompasses the comprehensive framework and methodology of the study emphasizing rigorous data collection quality assurance measures and statistical analysis strategies essential for evaluating the effectiveness of the mobile application-based follow-up program in post-total hip arthroplasty patients
Patients selected for this study have undergone total hip arthroplasty using the Furlong Evolution short stem and acetabular cup prosthetic design ACE Surgeries were performed at Hospital San Juan de Dios de Santurtzi and Hospital Universitario de Galdakao both located in Vizcaya
To analyze the new care model functional recovery program and patient follow-up via a digital application the entire study population from June 1 2023 to March 30 2024 will be included conducting a complete cohort analysis with a 3-month follow-up period
Data collection includes sociodemographic clinical and pre-surgical functional characteristics Specific assessment tests were employed to evaluate pain function and quality of life
Electronic health records will be used to collect data including demographic variables age gender medical history Patient-Reported Outcome Measures PROMs such as the Harris Hip Score and WOMAC scale and Patient-Reported-Experience-Mesures PREMs as satisfaction scale
Quality assurance procedures will be implemented to ensure data validity and registry integrity including data validation checks source data verification against external sources and a comprehensive data dictionary detailing each variable39s origin and coding information
Standard Operating Procedures SOPs will guide registry operations including patient recruitment data collection management analysis adverse event reporting and change management
A statistical analysis plan will employ appropriate analytical principles and techniques to address primary and secondary objectives outlined in the study protocol assessing the sample size required to demonstrate significant effects and strategies for handling missing data
This detailed description encompasses the comprehensive framework and methodology of the study emphasizing rigorous data collection quality assurance measures and statistical analysis strategies essential for evaluating the effectiveness of the mobile application-based follow-up program in post-total hip arthroplasty patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None