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Clinical Trials/NCT05672004
NCT05672004
Completed
N/A

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

UMC Utrecht1 site in 1 country27 target enrollmentDecember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
UMC Utrecht
Enrollment
27
Locations
1
Primary Endpoint
Adoption of ProMuscle
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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. In addition, the researchers hypothesized that the program would be adapted to specific contexts' outcomes from the recipients of ProMuscle will be collected. A hybrid type three trial aims to investigate the implementation as a primary outcome and the effect of the (adapted) intervention as a secondary outcome.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
May 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patricia van der Laag

Principal investigator, MSc

UMC Utrecht

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Adoption of ProMuscle

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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