Public HealthNCT06303700
Dyspnea, Risk of Falling and Quality of Life in Adolescents, Youth and Geriatric Groups
An observational study of Public Health, run by Amira Hussin Hussin Mohammed at 1 site in Egypt.
Trial summary
To assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the SF36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Public Health
- How many people
- 604 participants
- Where
- 1 siteEgypt
- Study dates
- 10 May 2022to 31 Jan 2024
- How long will I take part?
- 1 Day
- 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 12 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: All subjects were recruited from inhabitants of urban and rural areas in the Nile Delta Region, Egypt. They were assigned into 3 age-difference groups (adolescents, youth, and geriatrics).
Who may be able to join
- The participants were male or female community-dwellers, They ranged in age: adolescents from 12 to 17 years old, youth from 20 to 22 years old, and geriatrics from 60 to 80 years old.
Who cannot join
- subjects with mobility disabilities and severe cognitive impairments.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the SF36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics.
Read the detailed description
An observational study was done to assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the SF36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics. The participants in each group were assessed using the previously mentioned scales. Then the relationships between them were calculated and analyzed.
- Conditions
- Public Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adolescents | from both sex, age ranged from twelve to seventeen years old, free from mobility disability and Severe cognitive impairment | |
| youth | from both sex, age ranged from twenty to twenty-two years old, free from mobility disability and Severe cognitive impairment | |
| geriatrics | from both sex, age ranged from sixty to eighty years old, free from mobility disability and Severe cognitive impairment |
What is being measured
The primary outcome is the main question the study is designed to answer.
the severity of dyspnea
Using a dyspnea 12 (D-12) questionnaire that assesses the severity of dyspnea using a rubric of the physical and emotional aspects of dyspnea.
Measured: At the baseline evaluation
the level of fear of falling through daily life activities
Using Fall efficacy scale (FES-I) questionnaire that assesses the level of fear of falling through daily life activities
Measured: At the baseline evaluation
quality of life and public health
Using the Short Form 36 (SF-36) questionnaire. The questionnaire was assigned to eight domains: physical functioning, role-functioning, bodily pain, general health, vitality, social functioning, and role-emotional and mental health
Measured: At the baseline evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start10 May 2022
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Public HealthStudies 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
- Cross-sectional
- Enrolment
- 604 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Amira Hussin Hussin Mohammed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amira Hussin Hussin Mohammed, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303700
- Sponsor's protocol ID
- Quality of life
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyspnea, Risk of Falling and Quality of Life in Adolescents, Youth and Geriatric Groups
- ClinicalTrials.gov ID
- NCT06303700
- Acronym / sponsor ID
- Quality of life
- Conditions
- Public Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Amira Hussin Hussin MohammedUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 12 Mar 2024 (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.
To assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the SF36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics.
Detailed description
An observational study was done to assess the correlation between aspects of the dyspnea scale (indicating poor functionality), the fall efficacy scale (indicating a higher fear of falling), and all aspects of the SF36 (indicating quality of life) in 3 age groups: adolescents, youth, and geriatrics. The participants in each group were assessed using the previously mentioned scales. Then the relationships between them were calculated and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| adolescents | – | –from both sex, age ranged from twelve to seventeen years old, free from mobility disability and Severe cognitive impairment |
| youth | – | –from both sex, age ranged from twenty to twenty-two years old, free from mobility disability and Severe cognitive impairment |
| geriatrics | – | –from both sex, age ranged from sixty to eighty years old, free from mobility disability and Severe cognitive impairment |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All subjects were recruited from inhabitants of urban and rural areas in the Nile Delta Region, Egypt. They were assigned into 3 age-difference groups (adolescents, youth, and geriatrics).
Key inclusion criteria (1 listed)
- The participants were male or female community-dwellers, They ranged in age: adolescents from 12 to 17 years old, youth from 20 to 22 years old, and geriatrics from 60 to 80 years old.
Key exclusion criteria (1 listed)
- subjects with mobility disabilities and severe cognitive impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the severity of dyspnea
Time frame: At the baseline evaluation
Using a dyspnea 12 (D-12) questionnaire that assesses the severity of dyspnea using a rubric of the physical and emotional aspects of dyspnea.
the level of fear of falling through daily life activities
Time frame: At the baseline evaluation
Using Fall efficacy scale (FES-I) questionnaire that assesses the level of fear of falling through daily life activities
quality of life and public health
Time frame: At the baseline evaluation
Using the Short Form 36 (SF-36) questionnaire. The questionnaire was assigned to eight domains: physical functioning, role-functioning, bodily pain, general health, vitality, social functioning, and role-emotional and mental health
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 12 Mar 2024.
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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 Public Health, run by Amira Hussin Hussin Mohammed 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 1 inclusion and 1 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 12 Mar 2024. 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?
the severity of dyspnea (time frame: At the baseline evaluation). 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 12 Mar 2024.