NCT07139080

Brief Summary

Asthma patients with recurrent airway obstruction frequently exhibit poor symptom control, characterized by treatment non-adherence and sleep-wake cycle disturbances. A nurse-led mobile health education intervention may address these challenges by enhancing collaborative disease management, enabling remote patient monitoring, and strengthening self-management competencies. The AstımAsistan application was designed to monitor changes in patient self-efficacy, medication adherence, and sleep quality through three core features: (1) patient education modules, (2) breathing exercise/medication reminders, and (3) mobile consultation capabilities. Study data were collected using four instruments: (1) the Participant Information Form, (2) the Chronic Disease Self-Efficacy Scale, (3) the Medication Adherence Reporting Scale, and (4) the Pittsburgh Sleep Quality Index. The mobile education-based application was developed following the ADDIE (Analysis, Design, Development, Implementation, and Evaluation) instructional design model."

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

May 8, 2025

Last Update Submit

August 17, 2025

Conditions

Keywords

AsthmaSelf EfficacyMedication AdherenceMobile EducationSleep

Outcome Measures

Primary Outcomes (3)

  • Chronic Disease Self-Efficacy

    Chronic Disease Self Efficacy Scale: In this 30-item scale, each question is scored between 1 and 10 points to determine the level of self-efficacy. The total score obtained by the individual from the scale is divided by the number of items to calculate an overall self-efficacy average. The scale also has 10 subtitles. If the 30 items' average is below 7, it means the individual has low self-efficacy. If the average is 7 or above, it indicates that the individual has high self-efficacy regarding their illness and believes they can achieve their goals."

    10 weeks

  • Medication Adherence

    The Medication Adherence Report Scale (MARS), developed by Horne and Hankins (2001), can be adapted based on disease type. The scale requires participants to indicate the frequency of occurrence for 5 specific statements in themselves. The scoring uses a Likert-type scale where: 5=never, 4=rarely, 3=sometimes, 2=often, and 1=always. The total test score is obtained by summing the scores from all items. The minimum possible score on the scale is 5, and the maximum is 25. Higher scores indicate compliance, while lower scores suggest non-compliance.

    10 weeks

  • Sleep Quality

    PSQI is developed by Buysse et al. in 1989, this scale is used to assess sleep quality and identify factors contributing to sleep disorders. Its validity and reliability for our country were established by Ağargün et al. The scale consists of 18 scored items grouped into 7 component scores, with each item rated on a 0-3 scale. The components are: Subjective Sleep Quality Sleep Latency Sleep Duration Habitual Sleep Efficiency Sleep Disturbances Use of Sleep Medication Daytime Dysfunction The total scale score is calculated by summing the seven component scores. A total score of 5 or higher indicates poor sleep quality.

    10 weeks

Study Arms (2)

Mobile Education Group

EXPERIMENTAL

It consists of participants who will download the mobile patient education and breathing exercise reminder program and apply it for 10 weeks.

Behavioral: Mobile education

Control Group

NO INTERVENTION

This is the group of participants to be followed within the standard treatment plan. A mobile training and breathing exercise reminder program will be downloaded to patients in this group at the end of the study.

Interventions

It consists of participants who will download the mobile patient education and breathing exercise reminder program and apply it for 10 weeks.

Mobile Education Group

Eligibility Criteria

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

You may qualify if:

  • Being between the ages of 18-65
  • Having been diagnosed with asthma at least 6 months ago
  • Being treated for asthma in oral, inhaler or injection forms
  • Being literate in Turkish
  • Having an Android phone on which the mobile application can be installed and being able to use the phone
  • Having mobile network or wireless internet access
  • Volunteering to participate in research
  • Living in Ankara

You may not qualify if:

  • Being hospitalized for asthma treatment
  • Having a language barrier that hinders communication
  • Being diagnosed with COPD
  • Being diagnosed with a psychiatric disease
  • Being on psychoactive or opioid therapy
  • Being diagnosed with a sleep disorder related to non-respiratory reasons (physical and psychological) and being treated
  • Intervention group;
  • The participant was diagnosed with a health problem requiring inpatient treatment during the study period.
  • The participant withdraws from the study voluntarily.
  • Inability to use the mobile application during the research
  • Reading fewer than 6 theme headings in the mobile application (75% or less) and missing breathing exercises for more than 16 days (80% or less)
  • Control group;
  • The participant was diagnosed with a health problem requiring inpatient treatment during the study period.
  • The participant withdraws from the study voluntarily.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, KEÇİÖREN, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AsthmaMedication Adherence

Condition Hierarchy (Ancestors)

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

Study Officials

  • AYLA DEMİRTAŞ, Associate Professor

    UNIVERSITY OF HEALTH SCIENCES GULHANE FACULTY OF NURSING

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Randomization will be performed according to disease duration via calculatorsoup.com, a web-based program. It will be defined as the intervention group (M) and the control group (K). During the randomization process, numbered envelopes will be prepared by an academician outside the research for the patients included in the intervention and control groups. The researcher will learn the information about the intervention or control group in the prepared envelopes when the relevant envelope is opened during the interview with the patient. Thus, statistical blinding will be ensured.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

May 8, 2025

First Posted

August 24, 2025

Study Start

December 1, 2023

Primary Completion

April 28, 2025

Study Completion

April 28, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations