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

2018년 10월 16일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

195

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

40년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: 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
간섭 없음: Control
Patients in the control arm will receive care as usual.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
level of physical activity measured with the Personal Activity Monitor (PAM AM300)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Sedentary behaviour using the accelerometer using amount of minutes in the sedentary category (<1,8 METS)
기간: 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)
기간: 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)
기간: 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
기간: baseline - 6 months of follow up
Health status using the EQ-5D
baseline - 6 months of follow up

기타 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

UMC Utrecht

협력자

ZonMw: The Netherlands Organisation for Health Research and Development

수사관

  • 연구 의자: Marieke J. Schuurmans, PhD, UMC Utrecht
  • 수석 연구원: Heleen Westland, MSc, UMC Utrecht
  • 수석 연구원: Irene D Bos-Touwen, MSc, UMC Utrecht
  • 연구 의자: Jaap CA Trappenburg, PhD, UMC Utrecht
  • 연구 의자: Carin D Schröder, PhD, UMC Utrecht

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2016년 3월 1일

기본 완료 (실제)

2017년 11월 1일

연구 완료 (실제)

2017년 11월 1일

연구 등록 날짜

최초 제출

2016년 3월 25일

QC 기준을 충족하는 최초 제출

2016년 3월 30일

처음 게시됨 (추정)

2016년 3월 31일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 10월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 10월 16일

마지막으로 확인됨

2018년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NL54286.041.15

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

Not yet

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

심혈관 질환에 대한 임상 시험

Activate에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in New Zealand

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다