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

16 oktober 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

195

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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
Geen tussenkomst: Control
Patients in the control arm will receive care as usual.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
level of physical activity measured with the Personal Activity Monitor (PAM AM300)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (<1,8 METS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: baseline - 6 months of follow up
Health status using the EQ-5D
baseline - 6 months of follow up

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Potential effect modifier: age
Tijdsspanne: baseline
does age modify change in physical activity level
baseline
Potential effect modifier: depression using the Hospital Anxiety and Depression Scale (HADS)
Tijdsspanne: baseline
does depression modify change in physical activity level
baseline
Potential effect modifier: Body Mass Index (BMI)
Tijdsspanne: baseline
does BMI modify change in physical activity level
baseline
Potential effect modifier: level of education
Tijdsspanne: baseline
does education level modify change in physical activity
baseline
Potential effect modifier: social support using Multidimensional Scale of Perceived Social Support (MSPSS)
Tijdsspanne: baseline,
does social support modify change in level of physical activity
baseline,
Potential effect modifier: patient-provider relationship using the Communication Assessment Tool (CAT)
Tijdsspanne: 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
Tijdsspanne: baseline
does baseline amount of minutes of moderate to vigorous level of physical activity modify change in level of physical activity
baseline

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

UMC Utrecht

Medewerkers

ZonMw: The Netherlands Organisation for Health Research and Development

Onderzoekers

  • Studie stoel: Marieke J. Schuurmans, PhD, UMC Utrecht
  • Hoofdonderzoeker: Heleen Westland, MSc, UMC Utrecht
  • Hoofdonderzoeker: Irene D Bos-Touwen, MSc, UMC Utrecht
  • Studie stoel: Jaap CA Trappenburg, PhD, UMC Utrecht
  • Studie stoel: Carin D Schröder, PhD, UMC Utrecht

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 maart 2016

Primaire voltooiing (Werkelijk)

1 november 2017

Studie voltooiing (Werkelijk)

1 november 2017

Studieregistratiedata

Eerst ingediend

25 maart 2016

Eerst ingediend dat voldeed aan de QC-criteria

30 maart 2016

Eerst geplaatst (Schatting)

31 maart 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 oktober 2018

Laatste update ingediend die voldeed aan QC-criteria

16 oktober 2018

Laatst geverifieerd

1 oktober 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NL54286.041.15

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