Post COVID-19 SyndromeNCT04694768
Implementation of Rehabilitation Program for Post COVID-19
An observational study of Post COVID-19 Syndrome and Rehabilitation, run by Assiut University at 2 sites in Egypt.
Trial summary
Many people who have suffered from the effects of this disease might now be at risk of long-term impairment and disability. The extent of this impairment and disability is yet unknown, but it is clear from early research that these patients will be in need of rehabilitation in all phases of the disease - acute… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post COVID-19 Syndrome, Rehabilitation
- What is being tested?
- Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jul 2020to 31 Jan 2021
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients recovered from SARs-CoV-2 after 4 weeks
Who may be able to join
- Post acute COVID-19 patients
Who cannot join
- Acute COVID-10
- Non- COVID-19 patients
- Recent myocardial infarction
- Recent pulmonary embolism
- Neurologic diseases
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Aliae AR Mohamed-Hussein
Asyut, 71515
Aliae A Mohamed-Hussein, MD, +201222302352, aliaehussein@aun.edu.eg
- Recruiting
Aliae AR Mohamed-Hussein
Asyut, 71515
Aliae A Mohamed-Hussein, MD, 0122202352, aliaehussein@aun.edu.eg
About this study
Official title: The Effect of Implementing a Nursing Program Intervention on Improvement of Health Quality of Post Covid-19 Patients
Many people who have suffered from the effects of this disease might now be at risk of long-term impairment and disability. The extent of this impairment and disability is yet unknown, but it is clear from early research that these patients will be in need of rehabilitation in all phases of the disease - acute, post-acute and long-term.
Rehabilitation is defined as "a set of interventions designed to reduce disability and optimize functioning in individuals with health conditions in interaction with their environment." Rehabilitation might very well be a key strategy to reduce the impact of COVID-19 on the health and function of people.
A team work is needed to implement this programs which are essential in all phases to facilitate early discharge, but even more to support and empower patients.
- Conditions
- Post COVID-19 Syndrome, Rehabilitation
- Being tested
- Rehabilitation
- Keywords
- nursing program, health quality of life
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationBehavioural
Rehabilitation program
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimizing health and functioning outcomes
decrease intensive care acquired weakness
Measured: 6 months
improve recovery and reduce disability
decrease dyspnea, fatigue, anxiety and sleep disturbance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Jul 2020
- Primary completion1 Jan 2021
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliae AR Mohamed Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694768
- Sponsor's protocol ID
- AssiutU19
- Status last verified
- Jan 2021
- First submitted
- 3 Jan 2021
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Implementing a Nursing Program Intervention on Improvement of Health Quality of Post Covid-19 Patients
- ClinicalTrials.gov ID
- NCT04694768
- Acronym / sponsor ID
- AssiutU19
- Conditions
- Post COVID-19 Syndrome, Rehabilitation
- Keywords
- nursing program, health quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 5 Jan 2021 (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.
Many people who have suffered from the effects of this disease might now be at risk of long-term impairment and disability. The extent of this impairment and disability is yet unknown, but it is clear from early research that these patients will be in need of rehabilitation in all phases of the disease - acute, post-acute and long-term.
Rehabilitation is defined as "a set of interventions designed to reduce disability and optimize functioning in individuals with health conditions in interaction with their environment." Rehabilitation might very well be a key strategy to reduce the impact of COVID-19 on the health and function of people.
A team work is needed to implement this programs which are essential in all phases to facilitate early discharge, but even more to support and empower patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients recovered from SARs-CoV-2 after 4 weeks
Key inclusion criteria (1 listed)
- Post acute COVID-19 patients
Key exclusion criteria (5 listed)
- Acute COVID-10
- Non- COVID-19 patients
- Recent myocardial infarction
- Recent pulmonary embolism
- Neurologic diseases
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 |
|---|---|---|
| RehabilitationRehabilitation program | Behavioural | – |
Primary outcome
Optimizing health and functioning outcomes
Time frame: 6 months
decrease intensive care acquired weakness
improve recovery and reduce disability
Time frame: 6 months
decrease dyspnea, fatigue, anxiety and sleep disturbance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post COVID-19 Syndrome and Rehabilitation, run by Assiut University at 2 sites 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimizing health and functioning outcomes (time frame: 6 months). The study lists 2 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 5 Jan 2021.