Unravelling Effectiveness of a Nurse-led Behavior Change Intervention to Enhance Physical Activity in Patients
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Utrecht、オランダ、3531 HX
- GP Lombok
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Brabant
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Asten、Brabant、オランダ、5721CM
- GP Lienderweg
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Drunen、Brabant、オランダ、5151 HA
- GP Timmerman
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s Hertogenbosch、Brabant、オランダ、5235KG
- GP Emmers
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Gelderland
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Ede、Gelderland、オランダ、6713 NS
- GP Klaar and Vincent
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Hoevelaken、Gelderland、オランダ、3871EE
- GP Parklaan
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Gerlderland
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Buren、Gerlderland、オランダ、4116CW
- GP Buren
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Noord Holland
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Hilversum、Noord Holland、オランダ、1223DT
- GP Seinhorst
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Noord-Holland
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Amstelveen、Noord-Holland、オランダ、1186PJ
- GP Tjin a Ton and Parlevliet
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Bennebroek、Noord-Holland、オランダ、2121BB
- GP De Kennemerpoort
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Heerhugowaard、Noord-Holland、オランダ、1701 ER
- GP Odijk-Visser
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Heerhugowaard、Noord-Holland、オランダ、1701ER
- GP Munster
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Hilversum、Noord-Holland、オランダ、1215EK
- GP Eedenburgh
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Koedijk、Noord-Holland、オランダ、1831EK
- GP Koedijk
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Nieuw Vennep、Noord-Holland、オランダ、2152CA
- GP De Hollenhorst
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Wassenaar、Noord-Holland、オランダ、2241KE
- GP Spelt
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Overijssel
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Colmschate、Overijssel、オランダ、7429BG
- GP Jonker
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Kampen、Overijssel、オランダ、8265 DN
- GP Amarant
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Markelo、Overijssel、オランダ、7475AG
- GP Rosing and Bruins Slot
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Zwolle、Overijssel、オランダ、8042AD
- GP Blanker, Thiele, Brand
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Utrecht
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Bilthoven、Utrecht、オランダ、3723RC
- GP Provostlaan
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Bunnik、Utrecht、オランダ、3981EV
- GP van Steenis
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De BIlt、Utrecht、オランダ、3732BG
- GP De Bilt
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Leusden、Utrecht、オランダ、3831JR
- GP Tolgaarde
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Odijk、Utrecht、オランダ、3984MA
- GP Odijk
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Woudenberg、Utrecht、オランダ、3931 KJ
- GP De Schans
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Zuid-Holland
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Alphen aan den Rijn、Zuid-Holland、オランダ、2408 LA
- GP Sparreboom
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Boskoop、Zuid-Holland、オランダ、2771 EN
- GP Wiechen
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Schoonrewoerd、Zuid-Holland、オランダ、4145NV
- GP De Wiel
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The Hague、Zuid-Holland、オランダ、2525CE
- GP Mozaiek
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The Hague、Zuid-Holland、オランダ、2593WB
- GP Loudon
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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
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介入なし：Control
Patients in the control arm will receive care as usual.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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level of physical activity measured with the Personal Activity Monitor (PAM AM300)
時間枠：baseline - 6 months of follow up
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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).
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baseline - 6 months of follow up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (<1,8 METS)
時間枠：baseline -3 months and 6 months of follow up
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Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (<1,8 METS)
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baseline -3 months and 6 months of follow up
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Self-efficacy for physical activity using the Exercise Self-efficacy Scale (ESS)
時間枠：baseline - 3 months and 6 months of follow up
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Self-efficacy for physical activity using the Exercise Self-efficacy Scale (ESS), baseline, T0, T1, T2
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baseline - 3 months and 6 months of follow up
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Patient activation using the Patient Activation Measure (PAM-13)
時間枠：baseline -3 months and 6 months of follow up
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Patient activation using the Patient Activation Measure (PAM-13)
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baseline -3 months and 6 months of follow up
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Health status using the EQ-5D
時間枠：baseline - 6 months of follow up
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Health status using the EQ-5D
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baseline - 6 months of follow up
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Potential effect modifier: age
時間枠：baseline
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does age modify change in physical activity level
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baseline
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Potential effect modifier: depression using the Hospital Anxiety and Depression Scale (HADS)
時間枠：baseline
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does depression modify change in physical activity level
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baseline
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Potential effect modifier: Body Mass Index (BMI)
時間枠：baseline
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does BMI modify change in physical activity level
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baseline
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Potential effect modifier: level of education
時間枠：baseline
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does education level modify change in physical activity
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baseline
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Potential effect modifier: social support using Multidimensional Scale of Perceived Social Support (MSPSS)
時間枠：baseline,
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does social support modify change in level of physical activity
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baseline,
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Potential effect modifier: patient-provider relationship using the Communication Assessment Tool (CAT)
時間枠：baseline, 3 months and 6 months of follow up
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does the patient-provider relationship modify change in level of physical activity
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baseline, 3 months and 6 months of follow up
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Potential effect modifier: baseline amount of minutes of moderate to vigorous level of physical activity using the PAM AM300
時間枠：baseline
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does baseline amount of minutes of moderate to vigorous level of physical activity modify change in level of physical activity
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baseline
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Marieke J. Schuurmans, PhD、UMC Utrecht
- 主任研究者：Heleen Westland, MSc、UMC Utrecht
- 主任研究者：Irene D Bos-Touwen, MSc、UMC Utrecht
- スタディチェア：Jaap CA Trappenburg, PhD、UMC Utrecht
- スタディチェア：Carin D Schröder, PhD、UMC Utrecht
出版物と役立つリンク
一般刊行物
- Westland H, Trappenburg JCA, Schuurmans MJ, Zonneveld MH, Schroder CD. Fidelity of primary care nurses' delivery of a behavioural change intervention enhancing physical activity in patients at risk of cardiovascular disease: an observational study. BMJ Open. 2021 Mar 23;11(3):e046551. doi: 10.1136/bmjopen-2020-046551.
- Westland H, Schuurmans MJ, Bos-Touwen ID, de Bruin-van Leersum MA, Monninkhof EM, Schroder CD, de Vette DA, Trappenburg JC. Effectiveness of the nurse-led Activate intervention in patients at risk of cardiovascular disease in primary care: a cluster-randomised controlled trial. Eur J Cardiovasc Nurs. 2020 Dec;19(8):721-731. doi: 10.1177/1474515120919547. Epub 2020 May 6.
- Westland H, Sluiter J, Te Dorsthorst S, Schroder CD, Trappenburg JCA, Vervoort SCJM, Schuurmans MJ. Patients' experiences with a behaviour change intervention to enhance physical activity in primary care: A mixed methods study. PLoS One. 2019 Feb 12;14(2):e0212169. doi: 10.1371/journal.pone.0212169. eCollection 2019.
- Westland H, Koop Y, Schroder CD, Schuurmans MJ, Slabbers P, Trappenburg JCA, Vervoort SCJM. Nurses' perceptions towards the delivery and feasibility of a behaviour change intervention to enhance physical activity in patients at risk for cardiovascular disease in primary care: a qualitative study. BMC Fam Pract. 2018 Dec 12;19(1):194. doi: 10.1186/s12875-018-0888-1.
- Westland H, Bos-Touwen ID, Trappenburg JC, Schroder CD, de Wit NJ, Schuurmans MJ. Unravelling effectiveness of a nurse-led behaviour change intervention to enhance physical activity in patients at risk for cardiovascular disease in primary care: study protocol for a cluster randomised controlled trial. Trials. 2017 Feb 22;18(1):79. doi: 10.1186/s13063-017-1823-9.
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一次修了 (実際)
研究の完了 (実際)
試験登録日
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QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
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最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NL54286.041.15
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