Effectiveness of Asthma Education Program Based on the Roy Adaptation Model

NCT06766136 | Recruiting

• 1 other identifier: dnd1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma Patients

Keywords

Asthma patient; Psychosocial Adjustment; Life Quality

Outcome Measures

Primary Outcomes (1)

• "Evaluation of psychosocial adjustment of asthmatic individuals after education with the Psychosocial Adjustment To Illness-Self-Report Scale (PAIS-SR)".

  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 Outcomes (1)

• "Evaluation of the quality of life of asthmatic individuals after education with the Asthma Quality of Life Questionnaire (AQLQ)".

  "From enrollment to the end of treatment at 12 weeks"

Study Arms (2)

Asthma education program

EXPERIMENTAL

Experimental: Asthma education program Experiment group will receive an education program based on Roy Adaptation Model in addition to standard asthma treatment.

Behavioral: Asthma education program

Standard asthma treatment

NO INTERVENTION

No Intervention: Standard asthma treatment

Interventions

Asthma education program BEHAVIORAL

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

Asthma education program

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Nigde Omer Halisdemir University

Niğde, Center, 51100, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 23264406 RESULT

• 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.

  PMID: 22233301 RESULT

Study Officials

• Dondu Erdogan Inan, MSc

  Nigde Omer Halisdemir University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dondu Erdogan Inan, MSc

CONTACT

+903882112815; derdoganinan@ohu.edu.tr

Ulku Polat, PhD

CONTACT

+903122162903; ulku_gorgulu@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 9, 2025
• Study Start: December 20, 2024
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)