BurdenNCT05000606
A Home Visit Program and Perceived Care Burden
A study testing A home visit program in people with Burden, run by Gazi University.
Trial summary
The aim of this study was to determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial was used. The sample consisted of 30 participants in the intervention group and 30 participants in the control group. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Burden
- What is being tested?
- A home visit program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jul 2017
- Phase
- Interventional
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- giving care to a patient who was poorly controlled or uncontrolled asthma
- giving care to a patient who used an inhaler
- age 18 or over
- volunteering to participate to the study
Who cannot join
- having a disease with a neuro-psychiatric diagnosis
- having vision and hearing problems
About this study
Official title: The Effect of a Home Visit Program for Caregivers of Asthmatic Patients on Perceived Care Burden
The aim of this study was to determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial was used. The sample consisted of 30 participants in the intervention group and 30 participants in the control group. A home visit program including education and counseling was applied to participants in the intervention group.
Read the detailed description
The aim of this study was to determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial was used. The sample consisted of 30 participants in the intervention group and 30 participants in the control group. A home visit program including education and counseling was applied to participants in the intervention group. A total of five home visits over three months were performed. Data were collected by a personal information form, and the Zarit Caregiver Burden Scale (ZCBS).
- Conditions
- Burden
- Being tested
- A home visit program
- Keywords
- asthma, burden, caregiver, education, home visit
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A home visit programOther
A home visit program including education and counseling was applied. A total of five home visits over three months were performed.
| Study group | Role | What they receive |
|---|---|---|
| A home visit program | Experimental | A home visit program including five visits over three months were performed. Receives: Other: A home visit program |
| Control | No intervention | No other intervention was applied to the control group other than the standard education given in the outpatient clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zarit Caregiver Burden Scale
The scale consists of 18 questions. The minimum test score is 0 and the maximum score is 72. Care burden increases as the score from the scale increases.
Measured: Baseline
Zarit Caregiver Burden Scale
The scale consists of 18 questions. The minimum test score is 0 and the maximum score is 72. Care burden increases as the score from the scale increases.
Measured: Change from Baseline Perceived Care Burden Scores at 1 month
Zarit Caregiver Burden Scale
The scale consists of 18 questions. The minimum test score is 0 and the maximum score is 72. Care burden increases as the score from the scale increases.
Measured: Change from 1 month Perceived Care Burden Scores at 3rd months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study startNov 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sultan Ayaz Alkaya, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000606
- Sponsor's protocol ID
- 77082166-604.01.0
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 8 Jul 2024
- Results posted
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Home Visit Program for Caregivers of Asthmatic Patients on Perceived Care Burden
- ClinicalTrials.gov ID
- NCT05000606
- Acronym / sponsor ID
- 77082166-604.01.0
- Conditions
- Burden
- Keywords
- asthma, burden, caregiver, education, home visit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 11 Aug 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 determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial was used. The sample consisted of 30 participants in the intervention group and 30 participants in the control group. A home visit program including education and counseling was applied to participants in the intervention group.
Detailed description
The aim of this study was to determine the effect of a home visit program provided to the caregivers of asthmatic patients on the perceived care burden. A randomized controlled trial was used. The sample consisted of 30 participants in the intervention group and 30 participants in the control group. A home visit program including education and counseling was applied to participants in the intervention group. A total of five home visits over three months were performed. Data were collected by a personal information form, and the Zarit Caregiver Burden Scale (ZCBS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A home visit program | Experimental | Other: A home visit programA home visit program including five visits over three months were performed. |
| Control | No intervention | –No other intervention was applied to the control group other than the standard education given in the outpatient clinic |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- giving care to a patient who was poorly controlled or uncontrolled asthma
- giving care to a patient who used an inhaler
- age 18 or over
- volunteering to participate to the study
Key exclusion criteria (2 listed)
- having a disease with a neuro-psychiatric diagnosis
- having vision and hearing problems
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 |
|---|---|---|
| A home visit programA home visit program including education and counseling was applied. A total of five home visits over three months were performed. | Other | A home visit program |
Primary outcome
Zarit Caregiver Burden Scale
Time frame: Baseline
The scale consists of 18 questions. The minimum test score is 0 and the maximum score is 72. Care burden increases as the score from the scale increases.
Zarit Caregiver Burden Scale
Time frame: Change from Baseline Perceived Care Burden Scores at 1 month
The scale consists of 18 questions. The minimum test score is 0 and the maximum score is 72. Care burden increases as the score from the scale increases.
Zarit Caregiver Burden Scale
Time frame: Change from 1 month Perceived Care Burden Scores at 3rd months
The scale consists of 18 questions. The minimum test score is 0 and the maximum score is 72. Care burden increases as the score from the scale increases.
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 8 Jul 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing A home visit program in people with Burden, run by Gazi University.
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 4 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 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Zarit Caregiver Burden Scale (time frame: Baseline). 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 8 Jul 2024.