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Efficacy of Chronic Disease Self-management Program in People With Schizophrenia

8. november 2021 opdateret af: En-Chi Chiu, National Taipei University of Nursing and Health Sciences
This was a randomized controlled behavioral intervention trial to assess the efficacy of investigating program of chronic disease self-management program in people on schizophrenia patients conditions of depression, activities of daily living, social function, work, and quality of life.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Subjects were randomized to intervention group and control group. The primary outcome included eight measures, Stanford Self-Management Questionnaire, the Beck Depression Inventory-II, the Activities of Daily Living Rating Scale III, the Instrumental Activities of Daily Living Scale, the Participation Measure-3 Domains, 4 Dimensions, the Work Behavior Inventory, and the Schizophrenia-Quality of Life questionnaire.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Taiwan
    • Wanhua Dist
      • Taipei, Wanhua Dist, Taiwan, 108306
        • National Taipei University of Nursing and Health Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of schizophrenia by DSM-5
  • age > 20 years
  • Stable mental symptoms
  • Willing to sign the subject's consent

Exclusion Criteria:

  • History of severe brain injury
  • Substance abuse
  • Diagnosis of intellectual developmental disorder
  • Unable to follow instructions

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Self-management group
Self-management group Chronic disease self-management program is conduct training skills, person how to live together with personal chronic disease to make life quality better.
Andet: Chronic disease self-management program
The chronic disease self-management program is based on the self-efficacy theory for improving health behavior, by the solve health problem skill, health life style, emotion management skill, improve intention of health condition in people with chronic disease.
Placebo komparator: Control group
Control group will continue general psychiatric intervention.
Andet: General psychiatric intervention
General psychiatric intervention contains the activities in psychiatric center.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stanford Self-Management Questionnaire
Tidsramme: 6 week
The Stanford Self-Management Questionnaire is for Chronic Disease Self-management Program. A higher score indicates better self-management. Changes of the Canadian Occupational Performance Measure will be assessed at the 0 week, 6 weeks.
6 week
Beck Depression Inventory-II,
Tidsramme: 6 week

Beck Depression Inventory-II assesses the person about depression. A higher score indicates more depression.

Changes of Beck Depression Inventory-II will be assessed at the 0 week, 6 weeks.
6 week
Activities of Daily Living Rating Scale III,
Tidsramme: 6 week
Activities of Daily Living Rating Scale III assesses instrumental activities of daily living. A higher score indicates better activities of daily living. Changes of Activities of Daily Living Rating Scale III will be assessed at the 0 week, 6 weeks.
6 week
Instrumental Activities of Daily Living
Tidsramme: 6 week

Instrumental Activities of Daily Living assesses instrumental activities of daily living.

A higher score indicates better instrumental activities of daily living. Changes of Instrumental Activities of Daily Living will be assessed at the 0 week, 6 weeks.
6 week
Participation Measure-3 Domains Domains, 4 Dimensions
Tidsramme: 6 week
Participation Measure-3 Domains, 4 Dimensions assesses social participation. A higher score indicates better social participation. Changes of Participation Measure-3 Domains, 4 Dimensions will be assessed at the 0 week, 6 weeks.
6 week
Work Behavior Inventory
Tidsramme: 6 week
Work Behavior Inventory assesses work behavior about chronic mental patients. A lower score indicates better work behavior. Changes of Work Behavior Inventory will be assessed at the 0 week, 6 weeks.
6 week
Schizophrenia-Quality of Life questionnaire
Tidsramme: 6 week
Schizophrenia-Quality of Life questionnaire assesses schizophrenia quality of life. A higher score indicates better quality of life. Changes of Schizophrenia-Quality of Life questionnaire will be assessed at the 0 week, 6 weeks.
6 week
Mini Mental State Examination-2nd edition
Tidsramme: 6 week

Mini Mental State Examination general cognitive function. A higher score indicates better general cognitive function.

Changes of Mini Mental State Examination will be assessed at the 0 week, 6 weeks.
6 week

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Taipei University of Nursing and Health Sciences

Efterforskere

  • Studieleder: En-Chi Chiu, PhD, National Taipei University of Nursing and Health Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. september 2020

Primær færdiggørelse (Faktiske)

25. december 2020

Studieafslutning (Faktiske)

25. december 2020

Datoer for studieregistrering

Først indsendt

5. august 2020

Først indsendt, der opfyldte QC-kriterier

5. august 2020

Først opslået (Faktiske)

7. august 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. november 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. november 2021

Sidst verificeret

1. november 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TCHIRB-10904004

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Chronic disease self-management program

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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