Covid19NCT04872725
The Effect of Covid-19 Process
An observational study of Covid19 and Participation, Patient, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: The purpose of this study was to investigate the effect of the Covid-19 process on time management, participation, and leisure time activity. Methods: 531 individuals aged between 18-65 were included in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Participation, Patient
- What is being tested?
- Time management & participation & the leisure time activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 531 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 30 Jul 2020
- How long will I take part?
- 1 Month
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: aged between 18-65, signed "Informed Consent Form" and fulfilled the inclusion criteria
Who may be able to join
- aged between 18-65
- lived the Covid-19 process in Turkey
Who cannot join
- did not complete the scales
- did not live in Turkey
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Beykoz, Istanbul, 34810_
About this study
Official title: The Effect of Covid-19 Process on Time Management, Participation and Leisure Activity
Objective: The purpose of this study was to investigate the effect of the Covid-19 process on time management, participation, and leisure time activity.
Methods: 531 individuals aged between 18-65 were included in the study. The individuals were evaluated with the Assessment Of Time Management Skills (ATMS) in terms of time management, with the Social Isolation Questionnaire (SIQ) in terms of participation, and with the Interest Checklist (IC) in terms of leisure time activities.
- Conditions
- Covid19, Participation, Patient
- Being tested
- Time management & participation & the leisure time activity
- Keywords
- Covid-19, leisure time activities, participation, time management
- Medical subject headings
- COVID-19, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time management & participation & the leisure time activityBehavioural
evaluated in terms of leisure time activities, time management and participation
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Time Management Skills
It is a 30-item assessment tool that describes how different practical situations related to time management in a person's life are resolved or one's possible views on one's own time management skills. The scale is in 4-likert format and is evaluated as "1: Never, 2: Sometimes, 3: Most of the time, 4: Always" and the scores obtained are scored between 30-120. High scores indicate that time management skills and practices perform better. Eight items are reverse scored (items 7, 9, 10, 12, 18, 23, 26 and 30)
Measured: from March to June
Social Isolation Questionnaire
It consists of 6 items that evaluate the loneliness and perceived social isolation of the individual. A minimum score of 0 and a maximum of 24 points are obtained on the scale. 0 points means total social isolation, 24 points means high social relations. A value between 0-10 means complete social isolation, a value between 12-15 means isolation, a value between 16-18 means partial isolation, a value between 19-21 means social relation, and a value between 21-24 means a high social relationship.
Measured: from March to June
Interest Checklist
It is suitable for all population groups. The areas of interest are divided into 9 categories in each section, where relevant activities are listed and the individual can add their own activity. For each activity, it questions participation in the activity (in the past, ongoing and / or planned in the future) and degree of interest (strong, little, nothing).
Measured: from March to June
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Mar 2020
- Primary completion30 Jun 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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
- 531 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mbudak, Medipol University
- Investigators
- Miray BUDAK, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872725
- Sponsor's protocol ID
- Covid-19 OT
- Status last verified
- May 2021
- First submitted
- 2 May 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Covid-19 Process on Time Management, Participation and Leisure Activity
- ClinicalTrials.gov ID
- NCT04872725
- Acronym / sponsor ID
- Covid-19 OT
- Conditions
- Covid19, Participation, Patient
- Keywords
- Covid-19, leisure time activities, participation, time management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 4 May 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.
Objective: The purpose of this study was to investigate the effect of the Covid-19 process on time management, participation, and leisure time activity.
Methods: 531 individuals aged between 18-65 were included in the study. The individuals were evaluated with the Assessment Of Time Management Skills (ATMS) in terms of time management, with the Social Isolation Questionnaire (SIQ) in terms of participation, and with the Interest Checklist (IC) in terms of leisure time activities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- aged between 18-65, signed "Informed Consent Form" and fulfilled the inclusion criteria
Key inclusion criteria (2 listed)
- aged between 18-65
- lived the Covid-19 process in Turkey
Key exclusion criteria (2 listed)
- did not complete the scales
- did not live in Turkey
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 |
|---|---|---|
| Time management & participation & the leisure time activityevaluated in terms of leisure time activities, time management and participation | Behavioural | – |
Primary outcome
Assessment of Time Management Skills
Time frame: from March to June
It is a 30-item assessment tool that describes how different practical situations related to time management in a person's life are resolved or one's possible views on one's own time management skills. The scale is in 4-likert format and is evaluated as "1: Never, 2: Sometimes, 3: Most of the time, 4: Always" and the scores obtained are scored between 30-120. High scores indicate that time management skills and practices perform better. Eight items are reverse scored (items 7, 9, 10, 12, 18, 23, 26 and 30)
Social Isolation Questionnaire
Time frame: from March to June
It consists of 6 items that evaluate the loneliness and perceived social isolation of the individual. A minimum score of 0 and a maximum of 24 points are obtained on the scale. 0 points means total social isolation, 24 points means high social relations. A value between 0-10 means complete social isolation, a value between 12-15 means isolation, a value between 16-18 means partial isolation, a value between 19-21 means social relation, and a value between 21-24 means a high social relationship.
Interest Checklist
Time frame: from March to June
It is suitable for all population groups. The areas of interest are divided into 9 categories in each section, where relevant activities are listed and the individual can add their own activity. For each activity, it questions participation in the activity (in the past, ongoing and / or planned in the future) and degree of interest (strong, little, nothing).
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 11 May 2021.
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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.
Miray BUDAK, PhD principal investigator
Medipol University
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 Covid19 and Participation, Patient, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 11 May 2021. 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 Turkey (Türkiye). 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?
Assessment of Time Management Skills (time frame: from March to June). 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 11 May 2021.