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

16 ottobre 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

195

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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
Nessun intervento: Control
Patients in the control arm will receive care as usual.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
level of physical activity measured with the Personal Activity Monitor (PAM AM300)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (<1,8 METS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: baseline - 6 months of follow up
Health status using the EQ-5D
baseline - 6 months of follow up

Altre misure di risultato

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

UMC Utrecht

Collaboratori

ZonMw: The Netherlands Organisation for Health Research and Development

Investigatori

  • Cattedra di studio: Marieke J. Schuurmans, PhD, UMC Utrecht
  • Investigatore principale: Heleen Westland, MSc, UMC Utrecht
  • Investigatore principale: Irene D Bos-Touwen, MSc, UMC Utrecht
  • Cattedra di studio: Jaap CA Trappenburg, PhD, UMC Utrecht
  • Cattedra di studio: Carin D Schröder, PhD, UMC Utrecht

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2016

Completamento primario (Effettivo)

1 novembre 2017

Completamento dello studio (Effettivo)

1 novembre 2017

Date di iscrizione allo studio

Primo inviato

25 marzo 2016

Primo inviato che soddisfa i criteri di controllo qualità

30 marzo 2016

Primo Inserito (Stima)

31 marzo 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 ottobre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 ottobre 2018

Ultimo verificato

1 ottobre 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NL54286.041.15

Piano per i dati dei singoli partecipanti (IPD)

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Descrizione del piano IPD

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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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