Implementation of ProMuscle in Daily Practice

Sarcopenia Clinical Trial

— PUMP-fit  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05672004
• Other study ID #: 22/050
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: January 2025

Study information

• Verified date: January 2023
• Source: UMC Utrecht
• Contact: Patricia J van der Laag, MSc
• Phone: 003161118181
• Email: p.j.vanderlaag-3[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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 In and exclusion criteria 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

Related Conditions & MeSH terms

• Aging Problems
• Frailty
• Sarcopenia

Intervention

Other:
• PUMP-fit strategy (implementation toolbox)
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'.
• Implementation as usual
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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Regiodeal Foodvalley

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Fidelity of the PUMP-fit strategy	Fidelity is the degree to which an intervention was implemented as prescribed. For the PUMP-fit strategy, fidelity is defined as the degree to which the activities described in the online implementation toolbox are implemented as prescribed.; The number of implementation activities described in the implementation toolbox and the time healthcare professionals are active in the implementation toolbox will be collected from the online platform (tracking activity).; Fidelity according to healthcare professionals will be assessed with a self-report containing statements based on the Fidelity of Implementation (FOI) framework. The statements are scored with a 5-point Likert scale, the higher the score, the higher the fidelity.; In addition, the experience of healthcare professionals about the fidelity will be investigated during the process evaluation guided by the domain "implementation" of the RE-AIM framework.	24 weeks
Secondary	Acceptability of the PUMP-fit strategy	Acceptability will be measured with the translated Acceptability of Intervention Measure (AIM). The AIM contains four statements about the acceptability of the PUMP-fit implementation strategy. Statements are scored on a five-point Likert scale. The higher the score the higher the acceptability of the PUMP-fit strategy.	36 weeks
Secondary	Appropriateness of the PUMP-fit strategy	Appropriateness will be measured with the translated Intervention Appropriateness Measure (IAM). The IAM contains four statements about the appropriateness of the PUMP-fit implementation strategy. Statements are scored on a five-point Likert scale. The higher the score the higher the appropriateness of the PUMP-fit strategy.	36 weeks
Secondary	Feasibility of the PUMP-fit strategy	Feasibility will be measured with the translated Feasibility of Intervention Measure (FIM) questionnaire. The FIM contains four statements about the feasibility of the PUMP-fit implementation strategy. Statements are scored on a five-point Likert scale. The higher the score the higher the feasibility of the PUMP-fit strategy.	36 weeks
Secondary	Barriers and facilitators for implementation of ProMuscle	Barriers and facilitators will be assessed with a questionnaire developed by the research group. The questionnaire contains statements about different factors that could influence implementation (CFIR framework) and is based on the 'Wandersman readiness thinking tool' and 'Organization Readiness'. Statements are rated on a 5-point Likert scale. Factors that are scored three or lower will be defined as barriers. Factors that are scored with four of higher will be defined as facilitators.; Moreover, during the washout period and process evaluation barriers and facilitators will be identified in interviews with healthcare professionals implementing ProMuscle.	36 weeks
Secondary	Acceptability of ProMuscle	Acceptability of ProMuscle will be measured with the translated Acceptability of Intervention Measure (AIM) by the start of the implementation of ProMuscle (T0). Four statements are scored on a five-point Likert scale. The higher the score, the higher the score the higher the acceptability of the ProMuscle intervention	36 weeks
Secondary	Appropriateness of ProMuscle	Appropriateness will be measured with the translated Intervention Appropriateness Measure (IAM) by the start of the implementation of ProMuscle (T0). Four statements are scored on a five-point Likert scale, the higher the score the higher the appropriateness of ProMuscle.	36 weeks
Secondary	Feasibility of ProMuscle	Feasibility will be measured with the translated Feasibility of Intervention Measure (FIM) questionnaire by the start of the implementation of ProMuscle (T0). Four statements are scored on a five-point Likert scale, the higher the score, the higher the score the higher the feasibility of the ProMuscle intervention	36 weeks
Secondary	Reach of ProMuscle	Reach is defined as the number of older adults and will be measured by administrative data.	36 weeks
Secondary	Sustainment of ProMuscle	Sustainment of the implementation of ProMuscle will be measured with the Program Sustainability Assessment Tool (PSAT) and during a one-hour focus group guided by the RE-AIM framework (domain Maintenance) to assess if ProMuscle became part of daily care.	54 weeks
Secondary	Physical functioning recipients of ProMuscle	The Short Physical Performance Battery (SPPB) is conducted by participating healthcare professionals to asses physical functioning.	54 weeks
Secondary	Functional lower extremity strength recipients of ProMuscle	Repeated chair-rise test is conducted by participating healthcare professionals to assess functional strength.	54 weeks
Secondary	Leg strength recipients of ProMuscle	The one repetition (1RM) of leg strength is performed on leg press machines. The 1RM is conducted by participating healthcare professionals.; The 1RM measures the maximal strength and can be used to develop the exercise program.	54 weeks
Secondary	Functional mobility recipients of ProMuscle 1RM	Functional mobility is measured with the Timed-Up-And-Go test (TUG).	54 weeks
Secondary	Care dependency recipients of ProMuscle	Healthcare professionals report the current health status of the recipients in terms of care dependency. Recipients are asked if they receive care. Answers can be categorized as no care, care from spouse or family, domestic worker, home care, nursing or other help.	54 weeks
Secondary	Lean body mass recipients ProMuscle	Lean body mass is measured with the bioelectrical impedance analysis (BIA)	54 weeks