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临床试验/NCT05672004
NCT05672004已完成不适用

Implementation of the Combined Lifestyle Intervention ProMuscle for Community-living Older Adults in Community-care Practices.

UMC Utrecht1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
UMC Utrecht
入组人数
27
试验地点
1
主要终点
Adoption of ProMuscle

研究概览

简要总结

Implementation of a previously shown (cost-)effective combined lifestyle intervention for community living older adults, ProMuscle, in at least four of the eight communities of the 'Foodvalley' in the Netherlands.

详细描述

ProMuscle is a combined lifestyle intervention that has been shown effective in improving muscle mass, muscle strength, and physical functioning in community-dwelling older adults. Potentially, it could facilitate older people in maintaining their functional independence.

Despite the promising results, ProMuscle is still not part of daily care. Previously factors influencing successful implementation were identified and implementation strategies targeting these factors were developed and formatted as an implementation toolbox for healthcare professionals.

To increase the likelihood of successful implementation of ProMuscle, this study aims to investigate the PUMP-fit strategy (implementation toolbox) effectiveness on the adoption of ProMuscle in community-care

A hybrid type 3 stepped wedge cluster trial with a mixed method analysis will be conducted to assess the effectiveness of the PUMP-fit implementation toolbox. A stepped wedge trail is chosen because of the ability to compare between clusters, but also within clusters.

Moreover, ProMuscle is already found effective, and the researchers hypothesized that the implementation toolbox should be assessable for all healthcare professionals in the 'Foodvalley'. At last, a stepped wedge design is recommended if there is limited time and a small sample of professionals to recruit from in comparison to the total sample size that is needed to detect any effect.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

盲法说明

Recipients of ProMuscle are not the target group within this study. Healthcare professionals are the participants of the study, they know that they received the implementation toolbox once they switched to the intervention group

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •To be eligible to participate in this study, healthcare professionals must met the following criteria:
  • •Physical therapist, lifestyle coach or dietician in one of the communities in the Foodvalley in the Netherlands
  • •Interested in combined lifestyle programs for older adults
  • •Frequently involved in maintaining physical functioning in older adults

排除标准

  • •for older residents receiving ProMuscle are:
  • •Inclusion criteria:
  • •Aged 65 years or older
  • •Living in one of the eight communities of the 'Foodvalley' (Ede, Wageningen, Nijkerk, Rhenen, Veenendaal, Barneveld, Scherpenzeel, Renswoude)
  • •Able to understand Dutch
  • •Are pre-frail or frail (score 1 or more points on the Fried frailty criteria), or report loss of muscle strength
  • •Exclusion criteria:
  • •- One or more red flags for participating in progressive resistance exercise without consent of a medical specialist or general practitioner

研究组 & 干预措施

Implementation as usual

Active Comparator

Healthcare professionals will be instructed to implement ProMuscle in their practice as usual

干预措施: Implementation as usual (Other)

PUMP-fit strategy: Implementation toolbox

Experimental

Healthcare professionals receive a personal implementation toolbox, tailored to their contexts' barriers for implementation

干预措施: PUMP-fit strategy (implementation toolbox) (Other)

结局指标

主要结局

Adoption of ProMuscle

时间窗: 36 weeks

The number of healthcare professionals delivering ProMuscle is measured with administrative data and the REport of Sustainment Scale (PRESS). Because it is not possible to measure adoption at baseline, The Measure of Innovation-Specific Implementation Intentions (MISII) questionnaire will be used to measure adoptability (the attention to adopt an EBP) at T0

Fidelity of ProMuscle

时间窗: 36 weeks

Fidelity is the degree to which an intervention was implemented as prescribed. The number of activities described in the ProMuscle guideline executed by the healthcare professionals will be assessed with a self-report checklist based on the content of the ProMuscle intervention. Comparing the outcomes of fidelity before and after receiving the PUMP-fit strategy can indicate whether the toolbox contributed to the fidelity of delivery of ProMuscle.

次要结局

  • Appropriateness of the PUMP-fit strategy(36 weeks)
  • Appropriateness of ProMuscle(36 weeks)
  • Feasibility of ProMuscle(36 weeks)
  • Reach of ProMuscle(36 weeks)
  • Functional mobility recipients of ProMuscle 1RM(54 weeks)
  • Lean body mass recipients ProMuscle(54 weeks)
  • Barriers and facilitators for implementation of ProMuscle(36 weeks)
  • Acceptability of ProMuscle(36 weeks)
  • Functional lower extremity strength recipients of ProMuscle(54 weeks)
  • Leg strength recipients of ProMuscle(54 weeks)
  • Fidelity of the PUMP-fit strategy(24 weeks)
  • Acceptability of the PUMP-fit strategy(36 weeks)
  • Feasibility of the PUMP-fit strategy(36 weeks)
  • Sustainment of ProMuscle(54 weeks)
  • Physical functioning recipients of ProMuscle(54 weeks)
  • Care dependency recipients of ProMuscle(54 weeks)

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia van der Laag

Principal investigator, MSc

UMC Utrecht

研究点 (1)

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