Effectiveness of Asthma Education Program Based on the Roy Adaptation Model

June 13, 2025 updated by: Döndü ERDOĞAN İNAN, Nigde Omer Halisdemir University

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Center
      • Nigde, Center, Turkey, 51100
        • Recruiting
        • Nigde Omer Halisdemir University

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

  • Adult

Accepts Healthy Volunteers

Yes

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

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: 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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dondu Erdogan Inan, MSc, Nigde Omer Halisdemir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

December 20, 2024

Primary Completion (Actual)

May 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 13, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It will be shared after the article is published

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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