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Cardiovascular DiseasesNCT02725203

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

A study testing Activate in people with Cardiovascular Diseases, run by UMC Utrecht at 31 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Activate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
31 sitesNetherlands
Study dates
Mar 2016to Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Netherlands31 sites

  • GP Emmers

    's-Hertogenbosch, North Brabant, 5235KG

  • GP Sparreboom

    Alphen aan den Rijn, South Holland, 2408 LA

  • GP Tjin a Ton and Parlevliet

    Amstelveen, North Holland, 1186PJ

  • GP Lienderweg

    Asten, North Brabant, 5721CM

  • GP De Kennemerpoort

    Bennebroek, North Holland, 2121BB

  • GP Provostlaan

    Bilthoven, Utrecht, 3723RC

  • GP Wiechen

    Boskoop, South Holland, 2771 EN

  • GP van Steenis

    Bunnik, Utrecht, 3981EV

  • GP Buren

    Buren, Gerlderland, 4116CW

  • GP Jonker

    Colmschate, Overijssel, 7429BG

  • GP De Bilt

    De Bilt, Utrecht, 3732BG

  • GP Timmerman

    Drunen, North Brabant, 5151 HA

  • GP Klaar and Vincent

    Ede, Gelderland, 6713 NS

  • GP Odijk-Visser

    Heerhugowaard, North Holland, 1701 ER

  • GP Munster

    Heerhugowaard, North Holland, 1701ER

  • GP Eedenburgh

    Hilversum, North Holland, 1215EK

  • GP Seinhorst

    Hilversum, North Holland, 1223DT

  • GP Parklaan

    Hoevelaken, Gelderland, 3871EE

  • GP Amarant

    Kampen, Overijssel, 8265 DN

  • GP Koedijk

    Koedijk, North Holland, 1831EK

  • GP Tolgaarde

    Leusden, Utrecht, 3831JR

  • GP Rosing and Bruins Slot

    Markelo, Overijssel, 7475AG

  • GP De Hollenhorst

    Nieuw-Vennep, North Holland, 2152CA

  • GP Odijk

    Odijk, Utrecht, 3984MA

  • GP De Wiel

    Schoonrewoerd, South Holland, 4145NV

  • GP Mozaiek

    The Hague, South Holland, 2525CE

  • GP Loudon

    The Hague, South Holland, 2593WB

  • GP Lombok

    Utrecht, 3531 HX

  • GP Spelt

    Wassenaar, North Holland, 2241KE

  • GP De Schans

    Woudenberg, Utrecht, 3931 KJ

  • GP Blanker, Thiele, Brand

    Zwolle, Overijssel, 8042AD

Other trials in Netherlands

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Activate
Keywords
Cardiovascular risk management, behaviour change techniques, self-management, physical activity, nurse-led, behaviour change wheel, primary care, clustered RCT
Medical subject headings
Cardiovascular Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ActivateBehavioural

    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

Study groups in NCT02725203
Study groupRoleWhat they receive
Intervention: Activate interventionExperimentalParticipants 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.
Receives: Behavioral: Activate
ControlNo interventionPatients in the control arm will receive care as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. level of physical activity measured with the Personal Activity Monitor (PAM AM300)

    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).

    Measured: baseline - 6 months of follow up

Secondary outcomes (4)

  1. Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (<1,8 METS)

    Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (<1,8 METS)

    Measured: baseline -3 months and 6 months of follow up

  2. Self-efficacy for physical activity using the Exercise Self-efficacy Scale (ESS)

    Self-efficacy for physical activity using the Exercise Self-efficacy Scale (ESS), baseline, T0, T1, T2

    Measured: baseline - 3 months and 6 months of follow up

  3. Patient activation using the Patient Activation Measure (PAM-13)

    Patient activation using the Patient Activation Measure (PAM-13)

    Measured: baseline -3 months and 6 months of follow up

  4. Health status using the EQ-5D

    Health status using the EQ-5D

    Measured: baseline - 6 months of follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02725203
Sponsor's protocol ID
NL54286.041.15
Status last verified
Oct 2018
First submitted
25 Mar 2016
Last updated
18 Oct 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: Not yet

Publications

  • 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.

    PubMed 33757957

  • 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.

    PubMed 32375491

  • 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.

    PubMed 30753213

  • 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.

    PubMed 30541460

  • 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.

    PubMed 28228151

Questions about this trial

What is this clinical trial studying?

A study testing Activate in people with Cardiovascular Diseases, run by UMC Utrecht at 31 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

level of physical activity measured with the Personal Activity Monitor (PAM AM300) (time frame: baseline - 6 months of follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02725203, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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