NCT06269289

Brief Summary

Asthma is defined as a chronic inflammatory disorder of the airways associated with an extreme increase in airway hyperresponsiveness leading to recurrent wheezing, shortness of breath, chest tightness, and coughing attacks. The World Health Organization states that approximately 339 million individuals worldwide have asthma and more than 400 thousand deaths occur due to asthma every year. With effective and sustainable asthma management, it is possible to reduce disease-related complaints, admissions to emergency units and hospitalizations, limit the physiological and psychological effects of the disease, prevent dependence on healthcare professionals and caregivers, increase the quality of life and reduce the mortality of the disease. Patient education, which is within the educational role of professional nurses, is very important in asthma management. The research was planned in a single-center, randomized control group pretest-posttest design. The sample will consist of individuals who applied to the Allergy and Immunology clinic of Sureyyapasa Chest Diseases and Surgery Training and Research Hospital between May 2024 and January 2024, who have been diagnosed with asthma for at least one year and who accept the study \[25 intervention group - 25 control group\]. Groups will be determined using the random numbers table from the simple random sampling method. A web-based asthma education module will be created in line with the literature, and participants in the intervention group will be given synchronous training in 5 modules. After meeting the individuals in the intervention and control groups and obtaining verbal and written consent, they will be asked to fill out the Patient Information Form, Patient Empowerment Scale and Asthma Control Test prepared via Google Forms. A 30-minute training session will be given to the intervention group every week and there will be short evaluations after each training. When the 5th Module is completed, the intervention group will be asked to fill out the Patient Empowerment Scale and Asthma Control Test Scale. No intervention will be applied to the control group. 5. At the end of the module, the Patient Empowerment Scale and Asthma Control Test will be completed by individuals in the control group. It is thought that web-based asthma education that individuals will receive will positively affect their empowerment levels and increase their disease control.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

May 30, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

February 12, 2024

Last Update Submit

February 12, 2024

Conditions

Keywords

asthmaweb based interventioneducationnursingpatient empowerment

Outcome Measures

Primary Outcomes (1)

  • patient empowerment scale (PES)

    The scale consists of 37 items and five factors. Scale rating: 5-point Likert (1 = strongly disagree - 5 = strongly agree) The score that can be obtained from the scale varies between 37 and 185. As the score from the scale increases towards 5, patient empowerment is considered high, and as it decreases towards 1, patient empowerment is considered low.

    five weeks

Secondary Outcomes (1)

  • Asthma Control Test (ACT)

    five weeks

Study Arms (2)

intervention group

EXPERIMENTAL

It will be determined using a table of random numbers. The group has been diagnosed for at least 1 year, It will consist of people (25) between the ages of 18-65, who can read and write in Turkish, who volunteer to participate in the study and who have not received any training before. After meeting the individuals and obtaining their verbal and written consent, they will be asked to fill out the Patient Information Form, Patient Empowerment Scale and Asthma Control Test obtained through Google Forms. Post-tests will be applied to individuals who complete all 5 modules of training.

Other: web based education

Control group

ACTIVE COMPARATOR

The participants will be individuals who apply to the Allergy and Immunology Clinic of Istanbul Sureyyapasa Chest Diseases and Surgery Training and Research Hospital, have been diagnosed with asthma for at least one year and agree to participate in the study. It will consist of people who are between the ages of 18-65, understand Turkish, know how to read and write. Twenty five people selected by the randomization table method will be in the control group. They will be given the Ministry of Health's asthma education brochure. As in the intervention group, pre-test and post-test will be conducted.

Other: Standard education brochure

Interventions

Training presentations will be prepared in 5 modules by taking expert opinions in line with the literature. Training will be aimed at empowering patients to control asthma. It will include topics such as medication use, device use, exercise and disease management. Each week, an intervention group will be invited online to a module and the training will be given by the researcher.

intervention group

The control group will not be given web-based training, but will be given the standard asthma education brochure of the Ministry of Health.

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving treatment with a diagnosis of asthma for at least 1 year
  • Having severe asthma
  • Not having had any previous training
  • Being between the ages of 18-65,
  • Knowing how to read, write,
  • Volunteering to participate in research

You may not qualify if:

  • Having received treatment for less than 1 year
  • Being educated,
  • Not being at the level of severe asthma,
  • Not meeting the age criterion,
  • Not having the ability to understand, read and write Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AsthmaPatient Participation

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Neslihan Komser

    SUREYYAPASA CHEST DISEASES AND THORACIC SURGERY TRAINING AND RESEARCH HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research was designed as a randomized controlled experimental study with a pretest-posttest design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 21, 2024

Study Start

May 30, 2024

Primary Completion

June 30, 2024

Study Completion

September 30, 2024

Last Updated

February 21, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations