Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Self-Management in Adults With Asthma or COPD

4. november 2026 oppdatert av: Irem Hüzmeli, Mustafa Kemal University

Video Animation Versus Printed Educational Materials for Home-Based Self-Management Education in Adults With Asthma or COPD: A Randomized Controlled Trial

This study is a single-blind (evaluator-blind), parallel-group randomized controlled trial comparing two approaches to home-based pulmonary rehabilitation self-management training in individuals with chronic respiratory disease (asthma or COPD): brochure-based and video-animation-based. The topic is current and clinically relevant; the comparison of digital health literacy and patient education materials is a relatively understudied area in the literature. Sample size calculations were performed, the CONSORT 2010 guidelines were followed, and the statistical method (mixed-design ANOVA) is appropriate to the study question.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

104

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
    • Hatay
      • Antakya, Hatay, Tyrkia (Türkiye), 31010
        • Hatay Mustafa Kemal University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Diagnosis of COPD (GOLD 2026) or asthma (GINA 2025) The operational definition of clinical stability FEV₁ > 70% predicted for participants with asthma Smartphone access, if applicable

Exclusion Criteria:

Clinically unstable respiratory condition or acute disease exacerbation Neuromuscular disease Unstable cardiovascular disease Musculoskeletal disorder that could limit participation in the exercise program Cognitive impairment or mental disorder that could interfere with communication or compliance with the study procedures

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Video Education Group

Participants receive a six-week home-based self-management education program with standardized exercise advice delivered through animated educational videos, shared via WhatsApp and accessible on their personal smartphones. They are instructed to watch the videos and perform the recommended exercises at least three times per week for six weeks. The videos cover respiratory disease education, correct inhaler technique, breathing exercises, airway clearance techniques, lower-extremity strengthening exercises, and nutritional recommendations. Participants receive weekly telephone calls to monitor adherence, encourage continuation of the program, address questions, and confirm access to the videos.
Atferdsmessig: Video animation-based self-management education

Home-based self-management education with standardized exercise advice delivered through animated educational videos. The educational content, frequency, duration, and exercise advice are identical to those of the brochure-based intervention; only the mode of delivery differs. The program does not include individual exercise testing or supervised exercise training.
Aktiv komparator: Brochure Group

Participants receive the same six-week home-based self-management education program with standardized exercise advice delivered through a printed brochure with illustrated instructions. They are instructed to perform the recommended exercises at least three times per week for six weeks. The brochure covers the same content as the videos: respiratory disease education, correct inhaler technique, breathing exercises, airway clearance techniques, lower-extremity strengthening exercises, and nutritional recommendations. Participants receive weekly telephone calls identical to those in the video group to monitor adherence, encourage continuation of the program, and address questions.
Atferdsmessig: Brochure-based self-management education

Home-based self-management education with standardized exercise advice delivered through a printed brochure with illustrated instructions. The educational content, frequency, duration, and exercise advice are identical to those of the video animation-based intervention; only the mode of delivery differs. The program does not include individual exercise testing or supervised exercise training.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Chronic Disease Self-Management Scale
Tidsramme: At baseline (before the intervention) and at the end of week 6 (immediately after completion of the intervention).

Chronic Disease Self-Management Scale (CDSMS) total score, calculated as the sum of the four subscale scores (possible range 21-105) and assessed at baseline and week 6. Replace the current description of the score as the mean of the item scores (range 1-5), and state the scoring direction of the Self-Stigmatization subscale
At baseline (before the intervention) and at the end of week 6 (immediately after completion of the intervention).

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Self-Stigmatization subscale score of the Chronic Disease Self-Management Scale (CDSMS)
Tidsramme: Baseline and week 6

Description: Self-stigmatization subscale of the Turkish version of the Chronic Disease Self-Management Scale. Items are rated on a 5-point scale (1 = never to 5 = always) and summed. Higher scores indicate greater self-stigma (worse outcome)..
Baseline and week 6
Coping with Stigma subscale score of the Chronic Disease Self-Management Scale (CDSMS)
Tidsramme: Baseline and week 6

Coping with stigma subscale of the Turkish version of the Chronic Disease Self-Management Scale. Items are rated on a 5-point scale (1 = never to 5 = always) and summed. Higher scores indicate better ability to cope with stigma.
Baseline and week 6
Healthcare Effectiveness subscale score of the Chronic Disease Self-Management Scale (CDSMS)
Tidsramme: Baseline and week 6

Healthcare effectiveness subscale of the Turkish version of the Chronic Disease Self-Management Scale. Items are rated on a 5-point scale (1 = never to 5 = always) and summed. Higher scores indicate greater healthcare effectiveness
Baseline and week 6
Treatment Adherence subscale score of the Chronic Disease Self-Management Scale (CDSMS)
Tidsramme: Baseline and week 6

Treatment adherence subscale of the Turkish version of the Chronic Disease Self-Management Scale. Items are rated on a 5-point scale (1 = never to 5 = always) and summed. Higher scores indicate better treatment adherence.
Baseline and week 6

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mustafa Kemal University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. februar 2026

Primær fullføring (Faktiske)

1. juni 2026

Studiet fullført (Faktiske)

30. juni 2026

Datoer for studieregistrering

Først innsendt

28. juli 2026

Først innsendt som oppfylte QC-kriteriene

31. juli 2026

Først lagt ut (Faktiske)

3. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. november 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • hmkü

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

data available from the corresponding author upon reasonable request

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere