- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03216603
Health Literacy in People With Chronic Obstructive Pulmonary Disease
Health Literacy. An Intervention on Organized Information and Health Care for People With Chronic Obstructive Pulmonary Disease (COPD)
Health literacy refers to personal and relational factors affecting a person's ability to acquire, understand and use information about health and health services. In a need assessment study it was found that, the health services need to focus on health literacy factors in the follow up of patients with chronic obstructive pulmonary disease (COPD).
Thus, this project evaluate the effect a of a health literacy partnership health promotion intervention (hospital, municipalities, university) after discharge from hospital with the use of motivational interviewing and tailored follow-ups on re-admission, health literacy, self-management quality of life and cost in people with COPD compared with usual care.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Oslo, Norge, 0440
- Lovisenberg Diakonale Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Diagnosed with COPD,
- Above 18 years,
- Admitted to a medical department at the main intervention hospital, l
- Live in the sites belonging to the intervention hospital.
Exclusion Criteria:
- Not diagnosed with COPD,
- Not above 18 years,
- Not admitted to a medical department at the main intervention hospital, and
- Not living in the sites belonging to the intervention hospital.
- Cognitive failure
- Patients that are investigated or treated for cancer
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Health literacy intervention group
Health literacy intervention group will receive self-management help using a motivating interviewing technique delivered by nurses trained on motivating interviewing technique and COPD.
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In the health literacy intervention group all patients will receive self-management help using a motivating interviewing (MI) technique delivered by two MI and COPD trained nurses once a week for eight weeks after hospitalization.
Subsequently, the contact between the patients and the nurses will be by follow up motivational telephone calls once a month or more if needed for four months (i.a a total of six months intervention period).
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Ingen inngripen: Usual care group
Usual care group will receive usual follow up
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change of admissions
Tidsramme: Eight weeks, six months and one year
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Number of re-admissions
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Eight weeks, six months and one year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change of health literacy
Tidsramme: Eight weeks, six months and one year
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Questionnaire
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Eight weeks, six months and one year
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Change of disease specific quality of life
Tidsramme: Eight weeks, six months and one year
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Questionnaire
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Eight weeks, six months and one year
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Change of e-Health
Tidsramme: Eight weeks, six months and one year
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Questionnaire
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Eight weeks, six months and one year
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Change of physical function
Tidsramme: Eight weeks, six months and one year
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Questionnaire
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Eight weeks, six months and one year
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Change of self-management
Tidsramme: Eight weeks, six months and one year
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Questionnaire
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Eight weeks, six months and one year
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Change of psychological stress
Tidsramme: Eight weeks, six months and one year
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Questionnaire
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Eight weeks, six months and one year
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Change of self-efficacy
Tidsramme: Eight weeks, six months and one year
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Questionnaire
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Eight weeks, six months and one year
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Christine Borge, Phd, University of Oslo and Lovisenberg Diaconal Hospital
- Studiestol: Astrid K. Wahl, Phd, University of Oslo
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 298
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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