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Effectiveness of an APN-led Self-management Program in Patients in the First Year After Renal Transplantation (SMP-NEP)

30. april 2021 opdateret af: University of Zurich

Effectiveness of an Advanced Practice Nurse-led Self-management Program on Prevention of Weight Gain, Physical Activity and Medication Adherence in Patients in the First Year After Renal Transplantation

The aim of this study is to investigate the effectiveness of the program in patients after renal transplantation using a randomized controlled trial design. Physical, behavioural, and clinical outcomes will be measured at baseline before randomization then 8 and 12 months later.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Renal transplant recipients have to integrate preventive behaviours into their everyday lives. From the literature it is known that patients can only partially adhere to the recommended behaviours. An evidence-based self-management program to support patients in behaviour change was developed with a main focus on prevention of weight gain and increasing physical activity and medication adherence.

The aim of this study is to investigate the effectiveness of the program in patients in the first year after renal transplantation.

The specific aims of this study are:

  1. Compare differences in weight gain between subjects in the IG (intervention group) and in the CG (control group).
  2. Compare differences in the amount of physical exercise between subjects in the IG group and the CG.
  3. Compare differences in self-reported medication adherence between the subjects of the IG group and the CG.

Secondarily, differences in self-reported quality of life, anxiety and depression, and differences in patients' perception of health care provision regarding chronic illness between the subjects of the IG group and the CG will be compared.

Design: Randomised controlled trial, not blinded

Setting and time: The study will take place at the Nephrology Clinic, University Hospital Zürich, from 1 May 2012 through 31 April 2015.

Variables and Measurement: Physical, behavioural, and clinical outcomes will be measured at baseline, before randomization and then 8 and 12 months later. Medication adherence, physical activity, symptoms of depression and anxiety, quality of life and patients' perception of health care provided will be measured with validated questionnaires. Body weight, height, waist to hip ratio and body composition (BCM Fresenius) will be measured at the Nephrology Clinic. Physical activity will be measured with the pedometer StepWatchTM.

Intervention

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

122

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Schweiz
      • Zurich, Schweiz, 8091
        • University Hospital Zurich

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • received a kidney or a kidney-pancreas transplant in the University Hospital Zürich

Exclusion Criteria:

  • unstable psychiatric disorder
  • cognitive impairment
  • multi-organ transplantation with lung
  • liver or heart
  • illiteracy
  • not able to speak and understand German

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Styring
Adfærdsmæssigt: Usual Care, containing one session
Session takes place within the first three months after transplantation
Eksperimentel: Intervention

The intensity of the intervention follows a defined algorithm during the first eight months after renal transplantation. Behaviours are classified in three groups:

  • Group 1: Patients with optimal behaviour in all three behaviours.
  • Group 2: Patients with slight deviation (defined) from optimal behaviour in one or more behaviours.
  • Group 3: Patients with larger deviation (defined) from optimal behaviour in one or more behaviours.

All patients (group 1-3) will receive an assessment, education and a monthly reassessment.

Patients from group 2 und 3 will receive additionally behavioral education and peer involvement. Patients from group 3 will receive additionally a consilium of specialized healthcare professionals such as a nutritionist, physiotherapist, or psychologist.
Adfærdsmæssigt: Self-management program with monthly sessions
Patients participate in 9 sessions during the first 8th month after transplantaiton

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change from baseline BMI at 8 months
Tidsramme: 8th month
BMI
8th month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
difference of activity between control and intervention group at month 8
Tidsramme: month 8
differences in steps measured with pedometer (Stepwatch)
month 8
difference of activity between control and intervention group at month 12
Tidsramme: month 12
differences in steps measured with pedometer (Stepwatch)
month 12
change from baseline BMI at 12 months
Tidsramme: 12th month
BMI
12th month
difference of self-reported adherence between control and intervention group at month 8
Tidsramme: month 8
month 8
difference of self-reported adherence between control and intervention group at month 12
Tidsramme: month 12
month 12
change from baseline LTM at 8 months
Tidsramme: 8 months
LTM measured with Body Composition Analysis
8 months
change from baseline LTM at 12 months
Tidsramme: 12 months
LTM measured with Body Composition Analysis
12 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of Zurich

Efterforskere

  • Ledende efterforsker: Rebecca Spirig, PHD, RN, Nursing Director, Head Office of Nursing and Allied Health Professionals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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)

1. maj 2012

Primær færdiggørelse (Faktiske)

1. januar 2018

Studieafslutning (Faktiske)

1. februar 2018

Datoer for studieregistrering

Først indsendt

27. oktober 2014

Først indsendt, der opfyldte QC-kriterier

3. november 2014

Først opslået (Skøn)

4. november 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • KEK-ZK-Nr. 2011-0411

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med Self-management program with monthly sessions

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