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

2018年10月16日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

195

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

40年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
行为的：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
无干预：Control
Patients in the control arm will receive care as usual.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
level of physical activity measured with the Personal Activity Monitor (PAM AM300)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (<1,8 METS)
大体时间：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)
大体时间：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)
大体时间：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
大体时间：baseline - 6 months of follow up
Health status using the EQ-5D
baseline - 6 months of follow up

其他结果措施

结果测量
措施说明
大体时间
Potential effect modifier: age
大体时间：baseline
does age modify change in physical activity level
baseline
Potential effect modifier: depression using the Hospital Anxiety and Depression Scale (HADS)
大体时间：baseline
does depression modify change in physical activity level
baseline
Potential effect modifier: Body Mass Index (BMI)
大体时间：baseline
does BMI modify change in physical activity level
baseline
Potential effect modifier: level of education
大体时间：baseline
does education level modify change in physical activity
baseline
Potential effect modifier: social support using Multidimensional Scale of Perceived Social Support (MSPSS)
大体时间：baseline,
does social support modify change in level of physical activity
baseline,
Potential effect modifier: patient-provider relationship using the Communication Assessment Tool (CAT)
大体时间：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
大体时间：baseline
does baseline amount of minutes of moderate to vigorous level of physical activity modify change in level of physical activity
baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

UMC Utrecht

合作者

ZonMw: The Netherlands Organisation for Health Research and Development

调查人员

  • 学习椅：Marieke J. Schuurmans, PhD、UMC Utrecht
  • 首席研究员：Heleen Westland, MSc、UMC Utrecht
  • 首席研究员：Irene D Bos-Touwen, MSc、UMC Utrecht
  • 学习椅：Jaap CA Trappenburg, PhD、UMC Utrecht
  • 学习椅：Carin D Schröder, PhD、UMC Utrecht

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年3月1日

初级完成 (实际的)

2017年11月1日

研究完成 (实际的)

2017年11月1日

研究注册日期

首次提交

2016年3月25日

首先提交符合 QC 标准的

2016年3月30日

首次发布 (估计)

2016年3月31日

研究记录更新

最后更新发布 (实际的)

2018年10月18日

上次提交的符合 QC 标准的更新

2018年10月16日

最后验证

2018年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NL54286.041.15

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

Not yet

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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赞助者和合作者

医疗条件

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条件

罕见疾病

药物干预

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赞助者/合作者

地点

3
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