Clinical trial NCT06766136: Effectiveness of Asthma Education Program Based on the Roy Adaptation Model
Official title: The Effect of Education Given to Asthmatic Individuals According to Roy Adaptation Model on Psychosocial Adjustment and Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma Patients
Keywords: Asthma patient
Psychosocial Adjustment
Life Quality
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, stratified sampling based on gender and asthma control test (ACT) was used in this study. \[ACT; 24-20, female\], \[ACT≤19 24-20, female\], \[ACT; 24-20, male\], \[ACT≤19 24-20, male\] to ensure equal distribution in terms of gender and asthma control test in each group, strata were created. First, a scheme was developed to bi-randomize the gender and asthma control tests so that the experimental and control groups were stratified according to gender and asthma control tests. Permutation was also used to ensure a balance between strata. Block sets were created for each combination of prognostic factors (gender and asthma control test). The experimental and control groups were then randomized into strata using a table of random numbers.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study; to determine the effect of the education program given to individuals diagnosed with asthma based on Roy's adjustment model on their psychosocial adjustment to the disease and their quality of life.

Detailed description: In addition to the expected physiological effects of asthma on individuals, the course of the disease and the course of the individual's life will change as the duration of living with the disease increases. In order to improve the attitude towards the disease positively in asthmatic individuals, to ensure asthma control and to improve the quality of life by managing the process well, patients' behaviors against the disease should be improved. Regular repetition of trainings created within the framework of a specific plan to improve adaptation behaviors is one of the recommended steps to empower individuals with chronic diseases during the disease process. In this randomized controlled trial, individuals aged 18-64 years with a diagnosis of asthma, an asthma control test (ACT) score of 24-20 (partial control) or ≤19 (uncontrolled) and no secondary chronic disease other than asthma were included.

Eligibility criteria: 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

Primary outcomes:
measure: "Evaluation of psychosocial adjustment of asthmatic individuals after education with the Psychosocial Adjustment To Illness-Self-Report Scale (PAIS-SR)".
timeFrame: "From enrollment to the end of treatment at 12 weeks"
Secondary outcomes:
measure: "Evaluation of the quality of life of asthmatic individuals after education with the Asthma Quality of Life Questionnaire (AQLQ)".
timeFrame: "From enrollment to the end of treatment at 12 weeks"
Other outcomes:
Locations:
city: Nigde
country: Turkey
facility: Nigde Omer Halisdemir University
state: Center
Study officials:
affiliation: Nigde Omer Halisdemir University
name: Dondu Erdogan Inan, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.