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Effects of a Comprehensive Health Coaching Program in Advanced Chronic Obstructive Pulmonary Disease.

24. april 2018 oppdatert av: Taipei Medical University

Effects of a Comprehensive Health Coaching Program on Lung Function, Exercise Tolerance, Symptom Distress, Quality of Life, Readmission, and Survival in Advanced Chronic Obstructive Pulmonary Disease Patients: A Randomized Controlled Trial.

Chronic obstructive pulmonary disease due to incurable and prevalence has increased steadily, chronic respiratory disease is considered hazardous to health and quality of life of the disease. GOLD treatment guidelines (global initiative for chronic obstructive lung disease guideline) pointed out the pulmonary rehabilitation is one of the non-drug treatment in patients with severe COPD, shown to improve exercise capacity and reduce the short of breathing, improve the quality of life and reduce the anxiety associated and depression and improved survival advantages. Meanwhile, a few studies have examined effect the exercise training in severe COPD patients' symptom distress and quality of life, so as to make severe COPD patients to improve the effectiveness of the campaign to ongoing regular pulmonary rehabilitation movement, is considered an important issue.

It has been proposed that physical activity enhancement or exercise training can be effective in improving symptoms and quality of life in these patients. However, it has not been examined systematically. Therefore, the main purposes of this study are: 1.Prevalence of symptom distress; 2.The physical preferences; 3.The relationship between quality of life and physical activity; 4.Effects of Comprehensive Health coaching exercise training on improving fatigue, sleep disturbances, quality of life, readmission, and survival. In the first year of this study, a descriptive-correlational design will be used and in the second and third years of study, the experimental design and prospective longitudinal study will be undertaken. Instruments include motion sensors, physical activity scale, Physical Activity Preferences, Pittsburgh Sleep Quality of Life Index. Statistical analyses include descriptive statistics, t-test, one-way ANOVA, latent growth modeling, Logistic models, GEE, and survival analysis. Results from this study will provide important implications for improving symptom management and quality of life for sever chronic obstructive pulmonary disease patients.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Taiwan
      • Taipei, Taiwan
        • Rekruttering
        • Taipei Medical Hospital-Shuang Ho Hospital,Ministry of Health and Welfare

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

40 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • age ≥40 years and ≦80 years
  • patients with advanced COPD are defined according to the diagnostic criteria for severe (GOLD 3) and very severe (GOLD 4)
  • pulmonologist assess need pulmonary rehabilitation, but not accept any rehabilitation exercise program.
  • pulmonologist assessment the patients with a stable state.
  • awareness, has the ability to read, write, and communication.
  • willing to communicate by phone, and can operate smart phones.

Exclusion Criteria:

  • COPD AE requiring corticosteroids, antibiotics, emergency room visit or hospitalization within the past 3 month.
  • diagnosed mentally or cognitive disorder, such as dementia or unable to cooperate.
  • severe hip, knee disease, can not perform exercise, or with neuromuscular dysfunction, such as limb hemiplegia, no independent walking function or other deterioration due to bone and joint disease.
  • combined with severe heart disease, such as AMI, severe arrhythmia or heart failure.
  • current regular practice of physical activity

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Experiment
Comprehensive Health Coaching Program
Atferdsmessig: Comprehensive Health Coaching Program
Comprehensive Health Coaching Program: included physical activity and motivational interviewing techniques, participants were encouraged to set goals with decision-making, self-management and self-monitor their progress, and received support from researcher.
Ingen inngripen: Control
Guideline-based usual care

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline Lung function at 3 months, 6months
Tidsramme: 3 months, 6months
Spirometry (FEVl % predicted )
3 months, 6months
Change from Baseline Exercise Tolerance at 3 months, 6months
Tidsramme: 3 months, 6months
6 Minute walking test
3 months, 6months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from Baseline Health-related quality of life at 3 months, 6months
Tidsramme: 3 months, 6months
St. George's Respiratory Questionnaire
3 months, 6months
Change from Baseline Fatigue at 3 months, 6months
Tidsramme: 3 months, 6months
Brief Fatigue Inventory Short Form BFI-Taiwan Form
3 months, 6months
Change from Baseline Psychological distress at 3 months, 6months
Tidsramme: 3 months, 6months
Hospital Anxiety and Depression Scale
3 months, 6months
Change from Baseline Symptom Distress at 3 months, 6months
Tidsramme: 3 months, 6months
Taiwanese version of the M. D. Anderson Symptom Inventory
3 months, 6months
Change from Baseline Quality of Sleep at 3 months, 6months
Tidsramme: 3 months, 6months
Taiwanese version of the Pittsburgh Sleep Quality Index
3 months, 6months
Readmission rate Survival
Tidsramme: 1 year
pulmonologists blinded to allocation reviewed admission summaries and information to determine as COPD related readmission or mortality
1 year

Samarbeidspartnere og etterforskere

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

Sponsor

Taipei Medical 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)

1. mars 2018

Primær fullføring (Forventet)

31. juli 2020

Studiet fullført (Forventet)

31. juli 2020

Datoer for studieregistrering

Først innsendt

2. januar 2018

Først innsendt som oppfylte QC-kriteriene

6. januar 2018

Først lagt ut (Faktiske)

12. januar 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. april 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. april 2018

Sist bekreftet

1. november 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • N201704032

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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