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Unravelling Effectiveness of a Nurse-led Behavior Change Intervention to Enhance Physical Activity in Patients

16. oktober 2018 opdateret af: H.Westland, UMC Utrecht

Unravelling Effectiveness of a Nurse-led Behavior Change Intervention to Enhance Physical Activity in Patients With a Cardiovascular Risk: a Clustered-randomized Controlled Trial in Primary Care

A two-armed, cluster randomized controlled trial will be conducted comparing the Activate intervention with care as usual in 31 general practices in the Netherlands, in which approximately 279 patients at risk for cardiovascular disease will participate. The Activate intervention focuses on increasing physical activity and is developed using the Behavior Change Wheel (BCW). The activate intervention consists of four nurse-led consultations divided over a 3-months period. Primary outcome is the level of physical activity measured with an accelerometer. Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline amount of minutes of physical activity. Data will be collected at baseline, at 3 months and at 6 months of follow up.

Nurses will be trained in delivering the intervention by a one-day training and coaching sessions supervised. A process evaluation will be conducted.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Self-management interventions are considered effective in chronic disease patients, but trials have shown inconsistent results and it is unknown which patients benefit most. Adequate self-management requires behaviour change in patients and in healthcare providers to equip them in supporting patients in changing their behaviour. To unravel effectiveness of self-management, a nurse-led intervention was developed targeting at one self-management behaviour, namely physical activity, in primary care patients at risk for cardiovascular disease: the Activate intervention. This study aims to evaluate the effectiveness of the Activate intervention, to identify which patient-related characteristics modify change in physical activity levels in patients at risk for CVD in primary care, and to conduct a process evaluation.

A two-armed, cluster randomized controlled trial will be conducted comparing the Activate intervention with care as usual in 31 general practices in the Netherlands, in which approximately 300 patients at risk for cardiovascular disease will participate. The Activate intervention focuses on increasing physical activity and is developed using the Behavior Change Wheel (BCW). The activate intervention consists of four nurse-led consultations divided over a 3-months period in which 17 behaviour change techniques (BCTs) are integrated. Primary outcome is the level of physical activity measured with an accelerometer . Potential effect modifiers are age, body mass index, level of education, social support, depression, patient-provider relationship and baseline amount of minutes of physical activity. Data will be collected at baseline, at 3 months and at 6 months of follow up.

Subsequently, the BCW was applied to analyse what behavior change is needed in nurses to deliver the Activate intervention adequately. This resulted in a one-day training and coaching sessions supervised by a health psychologist and included 21 BCT.

A process evaluation will be conducted to evaluate the training of nurses, fidelity, dose and reach of the Activate intervention, identify barriers and facilitators for implementation and to assess participants' satisfaction.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

195

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Holland
      • Utrecht, Holland, 3531 HX
        • GP Lombok
    • Brabant
      • Asten, Brabant, Holland, 5721CM
        • GP Lienderweg
      • Drunen, Brabant, Holland, 5151 HA
        • GP Timmerman
      • s Hertogenbosch, Brabant, Holland, 5235KG
        • GP Emmers
    • Gelderland
      • Ede, Gelderland, Holland, 6713 NS
        • GP Klaar and Vincent
      • Hoevelaken, Gelderland, Holland, 3871EE
        • GP Parklaan
    • Gerlderland
      • Buren, Gerlderland, Holland, 4116CW
        • GP Buren
    • Noord Holland
      • Hilversum, Noord Holland, Holland, 1223DT
        • GP Seinhorst
    • Noord-Holland
      • Amstelveen, Noord-Holland, Holland, 1186PJ
        • GP Tjin a Ton and Parlevliet
      • Bennebroek, Noord-Holland, Holland, 2121BB
        • GP De Kennemerpoort
      • Heerhugowaard, Noord-Holland, Holland, 1701 ER
        • GP Odijk-Visser
      • Heerhugowaard, Noord-Holland, Holland, 1701ER
        • GP Munster
      • Hilversum, Noord-Holland, Holland, 1215EK
        • GP Eedenburgh
      • Koedijk, Noord-Holland, Holland, 1831EK
        • GP Koedijk
      • Nieuw Vennep, Noord-Holland, Holland, 2152CA
        • GP De Hollenhorst
      • Wassenaar, Noord-Holland, Holland, 2241KE
        • GP Spelt
    • Overijssel
      • Colmschate, Overijssel, Holland, 7429BG
        • GP Jonker
      • Kampen, Overijssel, Holland, 8265 DN
        • GP Amarant
      • Markelo, Overijssel, Holland, 7475AG
        • GP Rosing and Bruins Slot
      • Zwolle, Overijssel, Holland, 8042AD
        • GP Blanker, Thiele, Brand
    • Utrecht
      • Bilthoven, Utrecht, Holland, 3723RC
        • GP Provostlaan
      • Bunnik, Utrecht, Holland, 3981EV
        • GP van Steenis
      • De BIlt, Utrecht, Holland, 3732BG
        • GP De Bilt
      • Leusden, Utrecht, Holland, 3831JR
        • GP Tolgaarde
      • Odijk, Utrecht, Holland, 3984MA
        • GP Odijk
      • Woudenberg, Utrecht, Holland, 3931 KJ
        • GP De Schans
    • Zuid-Holland
      • Alphen aan den Rijn, Zuid-Holland, Holland, 2408 LA
        • GP Sparreboom
      • Boskoop, Zuid-Holland, Holland, 2771 EN
        • GP Wiechen
      • Schoonrewoerd, Zuid-Holland, Holland, 4145NV
        • GP De Wiel
      • The Hague, Zuid-Holland, Holland, 2525CE
        • GP Mozaiek
      • The Hague, Zuid-Holland, Holland, 2593WB
        • GP Loudon

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

40 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Aged 40-75

AND at least one of the following criteria:

  • have a high blood pressure (≥ 140 mmHg) or are already treated for high blood pressure
  • have a high total cholesterol (≥ 6.5 mmol/l) or already treated for high cholesterol
  • have diabetes mellitus type 2 (DM2)
  • have a positive family history of CVD AND Do not meet the Dutch Norm for Healthy Exercise according to the Short QUestionnaire to Asses Health (SQUASH).

Exclusion Criteria:

  • unable to give informed consent (eg. due to cognitive impairment),
  • unable to speak, write and read Dutch,
  • have contra-indications to increase their physical activity level (eg. unstable angina pectoris, unstable heart failure, acute illness)
  • have a terminal illness or have severe psychiatric illness or chronic disorder(s) that seriously influence the ability to improve their psychical activity level.
  • patients should not have participated in a program to increase their level of physical activity in the past 2 years.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention: Activate intervention
Participants in the intervention arm will visit their primary care nurse four times in a three-month period for structured and comprehensive support in achieving an improved level of physical activity.
Adfærdsmæssigt: Activate
The Activate intervention consists of four nurse-led consultations in a thee-month period. In the consultations patients receive structured and comprehensive support in achieving an improved level of physical activity. The Behavior Change Wheel was used to develop the Activate intervention, and led to a selection of 17 behavior change techniques, which are integrated in the Activate intervention
Ingen indgriben: Control
Patients in the control arm will receive care as usual.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
level of physical activity measured with the Personal Activity Monitor (PAM AM300)
Tidsramme: baseline - 6 months of follow up
The amount of minutes of physical activity in the moderate (3-6 METabolic equivalent (METS)) and vigorous categories (≥6 METS) at 6 months of follow up will be considered as primary outcome measure. Patients will be asked to wear the accelerometer during 7 consecutive days for 12 hours a day at baseline (T0), 3 months of follow up (T1) and at 6 months of follow up (T2).
baseline - 6 months of follow up

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (<1,8 METS)
Tidsramme: baseline -3 months and 6 months of follow up
Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (<1,8 METS)
baseline -3 months and 6 months of follow up
Self-efficacy for physical activity using the Exercise Self-efficacy Scale (ESS)
Tidsramme: baseline - 3 months and 6 months of follow up
Self-efficacy for physical activity using the Exercise Self-efficacy Scale (ESS), baseline, T0, T1, T2
baseline - 3 months and 6 months of follow up
Patient activation using the Patient Activation Measure (PAM-13)
Tidsramme: baseline -3 months and 6 months of follow up
Patient activation using the Patient Activation Measure (PAM-13)
baseline -3 months and 6 months of follow up
Health status using the EQ-5D
Tidsramme: baseline - 6 months of follow up
Health status using the EQ-5D
baseline - 6 months of follow up

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Potential effect modifier: age
Tidsramme: baseline
does age modify change in physical activity level
baseline
Potential effect modifier: depression using the Hospital Anxiety and Depression Scale (HADS)
Tidsramme: baseline
does depression modify change in physical activity level
baseline
Potential effect modifier: Body Mass Index (BMI)
Tidsramme: baseline
does BMI modify change in physical activity level
baseline
Potential effect modifier: level of education
Tidsramme: baseline
does education level modify change in physical activity
baseline
Potential effect modifier: social support using Multidimensional Scale of Perceived Social Support (MSPSS)
Tidsramme: baseline,
does social support modify change in level of physical activity
baseline,
Potential effect modifier: patient-provider relationship using the Communication Assessment Tool (CAT)
Tidsramme: baseline, 3 months and 6 months of follow up
does the patient-provider relationship modify change in level of physical activity
baseline, 3 months and 6 months of follow up
Potential effect modifier: baseline amount of minutes of moderate to vigorous level of physical activity using the PAM AM300
Tidsramme: baseline
does baseline amount of minutes of moderate to vigorous level of physical activity modify change in level of physical activity
baseline

Samarbejdspartnere og efterforskere

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

Sponsor

UMC Utrecht

Samarbejdspartnere

ZonMw: The Netherlands Organisation for Health Research and Development

Efterforskere

  • Studiestol: Marieke J. Schuurmans, PhD, UMC Utrecht
  • Ledende efterforsker: Heleen Westland, MSc, UMC Utrecht
  • Ledende efterforsker: Irene D Bos-Touwen, MSc, UMC Utrecht
  • Studiestol: Jaap CA Trappenburg, PhD, UMC Utrecht
  • Studiestol: Carin D Schröder, PhD, UMC Utrecht

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

1. marts 2016

Primær færdiggørelse (Faktiske)

1. november 2017

Studieafslutning (Faktiske)

1. november 2017

Datoer for studieregistrering

Først indsendt

25. marts 2016

Først indsendt, der opfyldte QC-kriterier

30. marts 2016

Først opslået (Skøn)

31. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NL54286.041.15

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