Elderly PopulationNCT04949724
Turkish Health Enhancement Lifestyle Profile-Screener Questionnaire
An observational study of Elderly Population, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the validity, reliability, and cultural adaptation of the Turkish version of the Health Enhancement Lifestyle Profile Screener (T-HELP-Screener). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly Population
- What is being tested?
- translation and adaptation study
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jan 2020to 9 Nov 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 65 years and older
- All sexes
- Older adult
Study population: elderly people
Who may be able to join
- age over 65 years, no communication problems, and a Mini-Mental State Examination score of 24 or above
Who cannot join
- communication problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychometric Properties of The Turkish Health Enhancement Lifestyle Profile-Screener Questionnaire (T-Help-Screener)
The aim of this study was to evaluate the validity, reliability, and cultural adaptation of the Turkish version of the Health Enhancement Lifestyle Profile Screener (T-HELP-Screener).
Read the detailed description
Internal consistency of the T-HELP-Screener was measured using Kuder-Richardson. Test-retest reliability was performed with 66 of the 150 participants using intraclass correlation coefficient (ICC). Construct validity of the T-HELP-Screener was analyzed with the Healthy Lifestyle Behavior Scale-II (HLBS-II).
- Conditions
- Elderly Population
- Being tested
- translation and adaptation study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
translation and adaptation studyOther
translation and adaptation study
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Lifestyle Behavior Scale-II
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start9 Jan 2020
- Primary completion9 Mar 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PopulationStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgü İnal, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949724
- Sponsor's protocol ID
- 2018/101
- Status last verified
- Jun 2021
- First submitted
- 29 Jun 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of The Turkish Health Enhancement Lifestyle Profile-Screener Questionnaire (T-Help-Screener)
- ClinicalTrials.gov ID
- NCT04949724
- Acronym / sponsor ID
- 2018/101
- Conditions
- Elderly Population
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 2 Jul 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.
The aim of this study was to evaluate the validity, reliability, and cultural adaptation of the Turkish version of the Health Enhancement Lifestyle Profile Screener (T-HELP-Screener).
Detailed description
Internal consistency of the T-HELP-Screener was measured using Kuder-Richardson. Test-retest reliability was performed with 66 of the 150 participants using intraclass correlation coefficient (ICC). Construct validity of the T-HELP-Screener was analyzed with the Healthy Lifestyle Behavior Scale-II (HLBS-II).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- elderly people
Key inclusion criteria (1 listed)
- age over 65 years, no communication problems, and a Mini-Mental State Examination score of 24 or above
Key exclusion criteria (1 listed)
- communication problem
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 |
|---|---|---|
| translation and adaptation studytranslation and adaptation study | Other | – |
Primary outcome
Healthy Lifestyle Behavior Scale-II
Time frame: 1 year
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 2 Jul 2021.
- Individual participant dataSharing planned: No
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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 Elderly Population, run by Hacettepe University 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 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 2 Jul 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?
Healthy Lifestyle Behavior Scale-II (time frame: 1 year). 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 2 Jul 2021.