Caregiver BurdenNCT05351528
of Caregiver Family Members for the Disabled in Bukhara
An observational study of Caregiver Burden, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
The responsibilities of caring for a disabled family member may cause caregivers to develop risky behaviors for caregiver's health. Therefore, we aimed to examine the relationship between caregiver burdens and healthy lifestyle behaviors of family members caring for a disabled child. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Questionnaire
- How many people
- 155 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Nov 2021to 30 Mar 2022
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Caregiver Family Member with disabled children
Who may be able to join
- Volunteering to participate in the study
- Having a disabled child to take care of
- Being literate
Who cannot join
- The age of the disabled person being cared for is over 24 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Burdens and Healthy Lifestyle Behaviors of Caregiver Family Members for the Disabled in Bukhara
The responsibilities of caring for a disabled family member may cause caregivers to develop risky behaviors for caregiver's health. Therefore, we aimed to examine the relationship between caregiver burdens and healthy lifestyle behaviors of family members caring for a disabled child.
Read the detailed description
In the study, family members living in Bukhara, Uzbekistan, and caring for a disabled person under the age of 24 were evaluated. Caregiver burden was evaluated with the Caregiver Burden Scale and healthy lifestyle behaviors were evaluated with the Healthy Lifestyle Behaviors Scale II. The fact that there is no earlier study on caregivers of disabled people in Uzbekistan and no research in the literature examining the relationship between caregiving burden and healthy lifestyle behaviors in individuals with disabled children, make this study unique.
- Conditions
- Caregiver Burden
- Being tested
- Questionnaire
- Keywords
- handicapped, caregiver burden, healthy lifestyle
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Caregiver burden and healthy lifestyle behaviors were evaluated.
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-demographic information
Age, height, body weight, employment status, income status, marital status
Measured: Two months
Number of child
Number of healthy and disabled children
Measured: Two months
Assessment of the child age
Age
Measured: Two months
Assessment of the child
Gender
Measured: Two months
Caregiver Burden Scale
The scale has a Likert-type rating ranging from 0 to 4 as "never, rarely, sometimes, quite often, almost always". A minimum of 0 and a maximum of 88 points can be obtained from the scale. The items in the scale are generally related to the social and emotional domain, and a high score indicates a high level of distress.
Measured: Two months
Secondary outcomes (1)
Healthy Lifestyle Behaviors Scale II
The scale is scored as "never (1)-regularly (4)". The lowest score for the whole scale is 52 and the highest score is 208. The high scores obtained from the scale indicate how high the individual applies the specified health behaviors.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start26 Nov 2021
- Primary completion30 Dec 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 155 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhayat KORKMAZ, Karadeniz Technical University
- Investigators
- Nurhayat Korkmaz, PhDstudent, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351528
- Sponsor's protocol ID
- KTU-SBU-FTR-01
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Burdens and Healthy Lifestyle Behaviors of Caregiver Family Members for the Disabled in Bukhara
- ClinicalTrials.gov ID
- NCT05351528
- Acronym / sponsor ID
- KTU-SBU-FTR-01
- Conditions
- Caregiver Burden
- Keywords
- handicapped, caregiver burden, healthy lifestyle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 28 Apr 2022 (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 responsibilities of caring for a disabled family member may cause caregivers to develop risky behaviors for caregiver's health. Therefore, we aimed to examine the relationship between caregiver burdens and healthy lifestyle behaviors of family members caring for a disabled child.
Detailed description
In the study, family members living in Bukhara, Uzbekistan, and caring for a disabled person under the age of 24 were evaluated. Caregiver burden was evaluated with the Caregiver Burden Scale and healthy lifestyle behaviors were evaluated with the Healthy Lifestyle Behaviors Scale II. The fact that there is no earlier study on caregivers of disabled people in Uzbekistan and no research in the literature examining the relationship between caregiving burden and healthy lifestyle behaviors in individuals with disabled children, make this study unique.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Caregiver Family Member with disabled children
Key inclusion criteria (3 listed)
- Volunteering to participate in the study
- Having a disabled child to take care of
- Being literate
Key exclusion criteria (1 listed)
- The age of the disabled person being cared for is over 24 years old.
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 |
|---|---|---|
| QuestionnaireCaregiver burden and healthy lifestyle behaviors were evaluated. | Other | – |
Primary outcome
Socio-demographic information
Time frame: Two months
Age, height, body weight, employment status, income status, marital status
Number of child
Time frame: Two months
Number of healthy and disabled children
Assessment of the child age
Time frame: Two months
Age
Assessment of the child
Time frame: Two months
Gender
Caregiver Burden Scale
Time frame: Two months
The scale has a Likert-type rating ranging from 0 to 4 as "never, rarely, sometimes, quite often, almost always". A minimum of 0 and a maximum of 88 points can be obtained from the scale. The items in the scale are generally related to the social and emotional domain, and a high score indicates a high level of distress.
1 secondary outcome
Healthy Lifestyle Behaviors Scale II
Time frame: Two months
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 28 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Caregiver Burden
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Not yet recruiting
Hand in Hand: Feasibility of a Compassion-Focused App to Support Parents of Children With Mental Health Problems
Physiological Conditions, Distress, Emotional
Active, not recruiting
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Caregiver Burnout
Not yet recruiting
A Mobile Informatics Solution to Assist Caregivers in Care Coordination and Monitoring Social Engagement
Memory Disorders, Mild Cognitive Impairment
Not yet recruiting
Parenting Program for Young Children With Spina Bifida
Spina Bifida
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.
Nurhayat Korkmaz, PhDstudent principal investigator
Karadeniz Technical 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 Caregiver Burden, run by Karadeniz Technical 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 3 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 28 Apr 2022. 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?
Socio-demographic information (time frame: Two months). The study lists 5 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 28 Apr 2022.