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NCT Number: NCT06766136

Effectiveness of Asthma Education Program Based on the Roy Adaptation Model

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.

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Key information

Conditions

Asthma Patients

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nigde Omer Halisdemir University

Niğde, Center, 51100, Turkey (Türkiye)

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Asthma education program

Behavioral

An educational program based on the Roy Adaptation Model in addition to standard asthma treatment.

Primary outcomes

  1. "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.

Secondary outcomes

  1. "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

Study contacts

Contact information is provided by the study sponsor or research team.

Dondu Erdogan Inan, MSc

CONTACT

[email protected]

+903882112815

Ulku Polat, PhD

CONTACT

[email protected]

+903122162903 ext. 216 26 62

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Registry information

Official study title

The Effect of Education Given to Asthmatic Individuals According to Roy Adaptation Model on Psychosocial Adjustment and Quality of Life

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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