Implementation of ProMuscle in Daily Practice

NCT05672004 | Completed

• 1 other identifier: 22/050
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Frailty; Aging Problems

Keywords

implementation; lifestyle intervention; prevention

Outcome Measures

Primary Outcomes (2)

• Adoption of ProMuscle

  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

  36 weeks

• Fidelity of ProMuscle

  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.

  36 weeks

Secondary Outcomes (16)

• Fidelity of the PUMP-fit strategy

  24 weeks

• Acceptability of the PUMP-fit strategy

  36 weeks

• Appropriateness of the PUMP-fit strategy

  36 weeks

• Feasibility of the PUMP-fit strategy

  36 weeks

• Barriers and facilitators for implementation of ProMuscle

  36 weeks

Study Arms (2)

Implementation as usual

ACTIVE COMPARATOR

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

Other: Implementation as usual

PUMP-fit strategy: Implementation toolbox

EXPERIMENTAL

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

Other: PUMP-fit strategy (implementation toolbox)

Interventions

PUMP-fit strategy (implementation toolbox) OTHER

Healthcare professionals will receive the ProMuscle training from one of the researchers during a one-hour online meeting (during the control period). Healthcare professionals will be informed about the platform and toolbox. Healthcare professionals receive a personal log-in for the online platform. Healthcare professionals receive a questionnaire about their readiness for implementation. The results of this questionnaire are directly visible on the platform Within the separate environment of the online platform, healthcare professionals can access their implementation toolbox. The toolbox is tailored to their personal context based on the results of the 'Readinesstool'.

PUMP-fit strategy: Implementation toolbox

Implementation as usual OTHER

First, healthcare professionals will receive the ProMuscle training from one of the researchers during a one-hour online meeting. At the end of the training healthcare professionals are informed about the mandatory conditions to implement ProMuscle (champion, material, approval of management). Healthcare professionals receive a questionnaire about their readiness for implementation. The results of this questionnaire are directly visible. Results contain a graph of possible barriers for implementation in their practice. Hereafter they will be instructed to start with implementation as usual.

Implementation as usual

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• \- One or more red flags for participating in progressive resistance exercise without consent of a medical specialist or general practitioner

Sponsors & Collaborators

• UMC Utrecht: lead
• Regiodeal Foodvalley: collaborator

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3508 GA, Netherlands

Location

MeSH Terms

Conditions

Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Lisette Schoonhoven, prof

  Julius Center, University Medical Center Utrecht, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MSc

Model Details: stepped wedge cluster trial and mixed methods process analysis

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 5, 2023
• Study Start: December 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)