- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05000606
A Home Visit Program and Perceived Care Burden
August 3, 2021 updated by: Sultan Ayaz Alkaya, Gazi University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- having a disease with a neuro-psychiatric diagnosis
- having vision and hearing problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A home visit program
A home visit program including five visits over three months were performed.
|
A home visit program including education and counseling was applied.
A total of five home visits over three months were performed.
Other Names:
|
Other: Control
No other intervention was applied to the control group other than the standard education given in the outpatient clinic
|
A home visit program including education and counseling was applied.
A total of five home visits over three months were performed.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Change from Baseline Perceived Care Burden Scores at 1 month
|
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.
|
Change from 1 month Perceived Care Burden Scores at 3rd months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
July 29, 2021
First Submitted That Met QC Criteria
August 3, 2021
First Posted (Actual)
August 11, 2021
Study Record Updates
Last Update Posted (Actual)
August 11, 2021
Last Update Submitted That Met QC Criteria
August 3, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 77082166-604.01.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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