Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

16 de octubre de 2018 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

195

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

40 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Conductual: 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
Sin intervención: Control
Patients in the control arm will receive care as usual.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
level of physical activity measured with the Personal Activity Monitor (PAM AM300)
Periodo de tiempo: 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 resultado secundarias

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

Otras medidas de resultado

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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

UMC Utrecht

Colaboradores

ZonMw: The Netherlands Organisation for Health Research and Development

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2016

Finalización primaria (Actual)

1 de noviembre de 2017

Finalización del estudio (Actual)

1 de noviembre de 2017

Fechas de registro del estudio

Enviado por primera vez

25 de marzo de 2016

Primero enviado que cumplió con los criterios de control de calidad

30 de marzo de 2016

Publicado por primera vez (Estimar)

31 de marzo de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de octubre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

16 de octubre de 2018

Última verificación

1 de octubre de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NL54286.041.15

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

Not yet

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir