Asthma PatientsNCT06766136
Effectiveness of Asthma Education Program Based on the Roy Adaptation Model
A study testing Asthma education program in people with Asthma Patients, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma Patients
- What is being tested?
- Asthma education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Nigde Omer Halisdemir University
Niğde, Center, 51100
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma Patients
- Being tested
- Asthma education program
- Keywords
- Asthma patient, Psychosocial Adjustment, Life Quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma education programBehavioural
An educational program based on the Roy Adaptation Model in addition to standard asthma treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Asthma education program |
| Standard asthma treatment | No intervention | No Intervention: Standard asthma treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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.
Measured: "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)".
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
Measured: "From enrollment to the end of treatment at 12 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start20 Dec 2024
- Primary completion1 May 2025
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asthma PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Döndü ERDOĞAN İNAN, Nigde Omer Halisdemir University
- Investigators
- Dondu Erdogan Inan, MSc, Principal investigator, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766136
- Sponsor's protocol ID
- dnd1
- Status last verified
- Jun 2025
- First submitted
- 23 Dec 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published
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.
PubMed 23264406Ozgen 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.
PubMed 22233301
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Asthmatic Individuals According to Roy Adaptation Model on Psychosocial Adjustment and Quality of Life
- ClinicalTrials.gov ID
- NCT06766136
- Acronym / sponsor ID
- dnd1
- Conditions
- Asthma Patients
- Keywords
- Asthma patient, Psychosocial Adjustment, Life Quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Asthma education program | Experimental | Behavioral: Asthma education programExperimental: Asthma education program Experiment group will receive an education program based on Roy Adaptation Model in addition to standard asthma treatment. |
| Standard asthma treatment | No intervention | –No Intervention: Standard asthma treatment |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asthma education programAn educational program based on the Roy Adaptation Model in addition to standard asthma treatment. | Behavioural | Asthma education program |
Primary outcome
"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.
1 secondary outcome
"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"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Results publication: PubMed 23264406Alpaydin 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.
- Results publication: PubMed 22233301Ozgen 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.
- Individual participant dataSharing planned: No. It will be shared after the article is published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dondu Erdogan Inan, MSc principal investigator
Nigde Omer Halisdemir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asthma education program in people with Asthma Patients, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dondu Erdogan Inan, MSc (+903882112815, derdoganinan@ohu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"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"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06766136, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025; AzTrials last refreshed its copy on 30 Oct 2026.