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

16 de outubro de 2018 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Real)

195

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

40 anos a 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Comportamental: 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
Sem intervenção: Control
Patients in the control arm will receive care as usual.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
level of physical activity measured with the Personal Activity Monitor (PAM AM300)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (<1,8 METS)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: baseline - 6 months of follow up
Health status using the EQ-5D
baseline - 6 months of follow up

Outras medidas de resultado

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

UMC Utrecht

Colaboradores

ZonMw: The Netherlands Organisation for Health Research and Development

Investigadores

  • Cadeira de estudo: Marieke J. Schuurmans, PhD, UMC Utrecht
  • Investigador principal: Heleen Westland, MSc, UMC Utrecht
  • Investigador principal: Irene D Bos-Touwen, MSc, UMC Utrecht
  • Cadeira de estudo: Jaap CA Trappenburg, PhD, UMC Utrecht
  • Cadeira de estudo: Carin D Schröder, PhD, UMC Utrecht

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de março de 2016

Conclusão Primária (Real)

1 de novembro de 2017

Conclusão do estudo (Real)

1 de novembro de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

25 de março de 2016

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de março de 2016

Primeira postagem (Estimativa)

31 de março de 2016

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de outubro de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de outubro de 2018

Última verificação

1 de outubro de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NL54286.041.15

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

Not yet

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