- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07742085
Self-Management in Adults With Asthma or COPD
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Hatay
-
Antakya, Hatay, Turkiet (Türkiye), 31010
- Hatay Mustafa Kemal University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
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. |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Chronic Disease Self-Management Scale
Tidsram: 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).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Self-Stigmatization subscale score of the Chronic Disease Self-Management Scale (CDSMS)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Immunsystemets sjukdomar
- Luftvägssjukdomar
- Lungsjukdomar
- Bronkialsjukdomar
- Lungsjukdomar, obstruktiv
- Respiratorisk överkänslighet
- Överkänslighet, Omedelbar
- Överkänslighet
- Patologiska tillstånd, tecken och symtom
- Lungsjukdom, kronisk obstruktiv
- Astma
Andra studie-ID-nummer
- hmkü
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
data available from the corresponding author upon reasonable request
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