- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04688840
Smartphone Application: A Possible Solution for Follow up of Patients With Hip Arthroplasty
Smartphone Application: A Possible Solution for Follow up of Patients With Hip Arthroplasty During COVID-19 Pandemic
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Tanta, Egypt
- Ahmed Samy
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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
|
follow up of patients with primary hip arthroplasty with at least one year follow up electronically and by routine method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 7 months
|
evaluate the function ad activity of the hip joint
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7 months
|
|
Short Form Health Survey Clinical care (SF12)
Time Frame: 7 months
|
describe general health status of the participant
|
7 months
|
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Self-Administered Patient Satisfaction Scale (SAPS)
Time Frame: 7 months
|
satisfaction of the participants with the method of follow up
|
7 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TantaH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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