Smartphone Application: A Possible Solution for Follow up of Patients With Hip Arthroplasty

• ClinicalTrials.gov Identifier: NCT04688840
• Recruitment Status: Completed
• First Posted: December 30, 2020
• Last Update Posted: December 30, 2020
• Sponsor: Tanta University
• Information provided by (Responsible Party): ahmed m. samy, Tanta University

Study Description

Brief Summary:

Introduction: Over the last decades, telemedicine has been used in many surgical aspects. Its role in postoperative follow up is of significant interest with a remarkable success. Since the appearance of COVID-19, the challenge is how to follow the recommendations of World Health Organization which stressed on the importance of social distancing to avoid infection and at the same time provides satisfactory medical services. This study was done to evaluate the feasibility and efficacy of Whatsapp social media program in postoperative follow up of patients with primary hip arthroplasty at the time of pandemic

Condition or disease	Intervention/treatment
Telemedicine	Procedure: hip arthropalsty

Detailed Description:

This is a prospective randomized comparative study. The investigators reviewed all registered patients underwent primary total hip arthroplasty (T.H.A.) at our department up to five years ago. Four hundred sixty three patients were recorded at our data base. After reviewing patients' files, the investigators excluded fifty two patients with follow up less than one year and 29 patients with a previous history of complications. Three hundred eighty two patients were initially eligible for the study. The investigators contacted them by telephone calls in order to ask them to be included in this study. The investigators were unable to contact 57 patients, 51 refused to be included, 31 preferred a personal contact with the surgeon, 14 patients were died and 51 patients did not have an internet access. One hundred seventy eight participants were finally eligible to be included in our research. Only 167 participants completed both electronic and routine follow up and these were our final materials. The investigators designed a group on WhatsApp for all participants included in the study. The questionnaires were sent on the group to be filled by the participants in addition to a request for routine x ray follow up. Also, the investigators used the group to send any announcement, schedule of routine visits and some instructions about how to answer the questionnaires. To keep the privacy of participants' information, every one was asked to resend the file and x- ray pictures to the surgeon private account. The investigators collected data received by all participants and reviewed them. If there was any serious complain or major radiological finding the investigators asked the participant for immediate clinical visit. One month later, the investigators started to recall all participants for routine follow up visit (RV) and reevaluate them clinically and radiologically. The investigators asked participants to calculate total time needed for completion of the questionnaires, time needed for x-ray and we added time needed for reviewing these files. The same was done at the RV including time of transportation. The investigators obtained a written consent from all of the participants after discussion about the aim of the research and the confidentiality of their data. All procedures performed in the study were in accordance with the ethical standards of our department and with the 1964 Helsinki declaration and its later amendments.

the investigators evaluated the effectiveness of the electronic visit (EV) by calculation of the number of missing complications or signs detected at the time of RV and require any interference or close observation

Study Design

• Study Type: Observational
• Actual Enrollment: 167 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Smartphone Application: A Possible Solution for Follow up of Patients With Hip Arthroplasty During COVID-19 Pandemic
• Actual Study Start Date: January 1, 2020
• Actual Primary Completion Date: September 1, 2020
• Actual Study Completion Date: December 1, 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
study results and satisfaction with telemedicine; the investigators designed a group on WhatsApp for all patients included in the study. The questionnaires were sent on the group to be filled by the patients in addition to a request for routine x ray follow up. Also, the investigators used the group to send any announcement, schedule of routine visits and some instructions about how to answer the questionnaires. To keep the privacy of patients' informations, every patient was asked to resend the file and x- ray pictures to the surgeon private account. the investigators collected data received by all patients and reviewed all x-rays. If there was any serious complain or major radiological finding the investigators asked the patient for immediate clinical visit.	Procedure: hip arthropalsty; follow up of patients with primary hip arthroplasty with at least one year follow up electronically and by routine method
study results and satisfaction with routine follow up; the investigators asked the patients to come for routine follow up visit (RV) and reevaluate them clinically and radiologically. the investigators asked patients to calculate total time needed for completion of the questionnaires, time needed for x-ray and the investigators added time needed for reviewing these files. The same was done at the RV including time of transportation	Procedure: hip arthropalsty; follow up of patients with primary hip arthroplasty with at least one year follow up electronically and by routine method

Outcome Measures

Primary Outcome Measures :

1. Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 7 months ]
   evaluate the function ad activity of the hip joint
2. Short Form Health Survey Clinical care (SF12) [ Time Frame: 7 months ]
   describe general health status of the participant
3. Self-Administered Patient Satisfaction Scale (SAPS) [ Time Frame: 7 months ]
   satisfaction of the participants with the method of follow up

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

patients with primary total hip arthroplasty without history of postoperative complications

Criteria

inclusion criteria:

• patients underwent primary hip arthroplasty for at least one year ago
• familiarity of the patient or one of close relative (e.g. son or daughter) with smart phone applications.

Exclusion Criteria:

• patients that have no facility or experience with computer or internet and do not have a close relative to assist them
• patients with any previous complications (e.g. Infection, dislocation and loosening).

Contacts and Locations

Locations

Egypt

Ahmed Samy

Tanta, Egypt

Sponsors and Collaborators

Tanta University

More Information

• Responsible Party: ahmed m. samy, assisstant professor, Tanta University
• ClinicalTrials.gov Identifier: NCT04688840
• Other Study ID Numbers: TantaH
• First Posted: December 30, 2020
• Last Update Posted: December 30, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: when i publish the data

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ahmed m. samy, Tanta University:

Whatsapt; hip arthroplasty; Telemedicine; patient's satisfaction