TelemedicineNCT04688840
Smartphone Application: A Possible Solution for Follow up of Patients With Hip Arthroplasty
An observational study of Telemedicine, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Telemedicine
- What is being tested?
- hip arthropalsty
- Type of treatment
- Surgery or procedure
- How many people
- 167 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with primary total hip arthroplasty without history of postoperative complications
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone Application: A Possible Solution for Follow up of Patients With Hip Arthroplasty During COVID-19 Pandemic
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
Read the 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
- Conditions
- Telemedicine
- Being tested
- hip arthropalsty
- Keywords
- Whatsapt, hip arthroplasty, Telemedicine, patient's satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip arthropalstyProcedure or surgery
follow up of patients with primary hip arthroplasty with at least one year follow up electronically and by routine method
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: hip arthropalsty | |
| 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 Receives: Procedure: hip arthropalsty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
evaluate the function ad activity of the hip joint
Measured: 7 months
Short Form Health Survey Clinical care (SF12)
describe general health status of the participant
Measured: 7 months
Self-Administered Patient Satisfaction Scale (SAPS)
satisfaction of the participants with the method of follow up
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Jan 2020
- Primary completion1 Sep 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed m. samy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688840
- Sponsor's protocol ID
- TantaH
- Status last verified
- Dec 2020
- First submitted
- 14 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: when i publish the data
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Application: A Possible Solution for Follow up of Patients With Hip Arthroplasty During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04688840
- Acronym / sponsor ID
- TantaH
- Conditions
- Telemedicine
- Keywords
- Whatsapt, hip arthroplasty, Telemedicine, patient's satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study results and satisfaction with telemedicine | – | Procedure: hip arthropalstythe 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. |
| study results and satisfaction with routine follow up | – | Procedure: hip arthropalstythe 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with primary total hip arthroplasty without history of postoperative complications
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hip arthropalstyfollow up of patients with primary hip arthroplasty with at least one year follow up electronically and by routine method | Procedure or surgery | study results and satisfaction with routine follow up, study results and satisfaction with telemedicine |
Primary outcome
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 7 months
evaluate the function ad activity of the hip joint
Short Form Health Survey Clinical care (SF12)
Time frame: 7 months
describe general health status of the participant
Self-Administered Patient Satisfaction Scale (SAPS)
Time frame: 7 months
satisfaction of the participants with the method of follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Individual participant dataSharing planned: Undecided. when i publish the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Telemedicine, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 7 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.