- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06766136
Effectiveness of Asthma Education Program Based on the Roy Adaptation Model
The Effect of Education Given to Asthmatic Individuals According to Roy Adaptation Model on Psychosocial Adjustment and Quality of Life
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dondu Erdogan Inan, MSc
- Phone Number: +903882112815
- Email: derdoganinan@ohu.edu.tr
Study Contact Backup
- Name: Ulku Polat, PhD
- Phone Number: 216 26 62 +903122162903
- Email: ulku_gorgulu@yahoo.com
Study Locations
-
-
Center
-
Nigde, Center, Turkey, 51100
- Recruiting
- Nigde Omer Halisdemir University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being in the age range of 18-64
- Diagnosed with asthma for at least 6 months
- To live in the city center
- Asthma control test (ACT) score 24-20 (partial control) or ≤19 (uncontrolled)
- Patients who voluntarily agreed to participate in the study
Exclusion Criteria:
- Has a secondary chronic disease other than asthma
- Diagnosed with neuropsychiatric illness
- Individuals with inability to understand or speak Turkish and sensory problems that prevent communication
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Asthma education program
Experimental: Asthma education program Experiment group will receive an education program based on Roy Adaptation Model in addition to standard asthma treatment.
|
An educational program based on the Roy Adaptation Model in addition to standard asthma treatment.
|
|
No Intervention: Standard asthma treatment
No Intervention: Standard asthma treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
"Evaluation of psychosocial adjustment of asthmatic individuals after education with the Psychosocial Adjustment To Illness-Self-Report Scale (PAIS-SR)".
Time Frame: "From enrollment to the end of treatment at 12 weeks"
|
Patient Introduction Form This form was prepared by the researcher in line with the literature and consists of 12 questions to determine patient and disease characteristics. Psychosocial Adaptation to Illness-Self-Report Scale (PAIS-SR) Psychosocial Adaptation to Illness-Self-Report Scale (PAIS-SR) The Psychosocial Adjustment to Illness - Self-Report Scale was developed by Derogatis in 1986 to assess psychosocial adjustment to illness. The scale consists of 7 sub-dimensions and a total of 46 questions. Scores that can be obtained from the scale vary between "0 - 138". Scores below 35 indicate "good psychosocial adjustment", scores between 35 and 51 indicate moderately "good psychosocial adjustment", and scores above 51 indicate "poor psychosocial adjustment". In the original version of the scale, Cronbach's alpha coefficient was found to be 0.86. |
"From enrollment to the end of treatment at 12 weeks"
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
"Evaluation of the quality of life of asthmatic individuals after education with the Asthma Quality of Life Questionnaire (AQLQ)".
Time Frame: "From enrollment to the end of treatment at 12 weeks"
|
Patient Introduction Form This form was prepared by the researcher in line with the literature and consists of 12 questions to determine patient and disease characteristics. Asthma Quality of Life Questionnaire (AQLQ) The Asthma Quality of Life Questionnaire (AQLQ) is an asthma-specific quality of life scale consisting of 32 questions and 4 subscales developed by Juniper et al. The scale is a 7-point Likert-type scale with "1" representing the lowest and "7" the highest score. The total score of the scale ranges from 32 to 224 and the mean score ranges from 1 to 7. Overall quality of life is calculated by summing and averaging the relevant domain values of all questions and sub-dimensions. An increase in the mean value of the overall and sub-dimensions of the scale increases the quality of life. It was found that the Cronbach alpha coefficients of the sub-dimensions of the scale ranged between 0.81-0.87 |
"From enrollment to the end of treatment at 12 weeks"
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dondu Erdogan Inan, MSc, Nigde Omer Halisdemir University
Publications and helpful links
General Publications
- Alpaydin AO, Bora M, Yorgancioglu A, Coskun AS, Celik P. Asthma control test and asthma quality of life questionnaire association in adults. Iran J Allergy Asthma Immunol. 2012 Dec;11(4):301-7.
- Ozgen Alpaydin A, Yorgancioglu A, Yilmaz O, Bora M, Goktalay T, Celik P, Yuksel H. Validity and reliability of "Asthma Quality of Life Questionnaire" in a sample of Turkish adult asthmatic patients. Tuberk Toraks. 2011;59(4):321-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- dnd1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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